Trial Outcomes & Findings for Cytokine Induced Memory-like NK Cell Adoptive Therapy for Relapsed AML After Allogeneic Hematopoietic Cell Transplant (NCT NCT03068819)
NCT ID: NCT03068819
Last Updated: 2026-04-24
Results Overview
-Feasibility is defined as the ability to generate and successfully infuse CIML NK cells with SOC donor lymphocyte infusion (DLI). Will be considered successful if doses above the minimum can be delivered in at least 18 of 24 patients. Target and minimum CIML doses are maximum capped at 20x10\^6/kg with a minimum dose of 0.5x10\^6 kg.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
62 participants
Primary outcome timeframe
Completion of all recipients through Day 0
Results posted on
2026-04-24
Participant Flow
Participant milestones
| Measure |
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered \> 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
|
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered \> 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
|
Donors
On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
15
|
28
|
|
Overall Study
COMPLETED
|
18
|
14
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered \> 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
|
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered \> 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
|
Donors
On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
|
|---|---|---|---|
|
Overall Study
Recipient did not receive treatment
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Disease progression prior to treatment
|
1
|
0
|
0
|
Baseline Characteristics
Cytokine Induced Memory-like NK Cell Adoptive Therapy for Relapsed AML After Allogeneic Hematopoietic Cell Transplant
Baseline characteristics by cohort
| Measure |
Donors
n=28 Participants
On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
|
Total
n=62 Participants
Total of all reporting groups
|
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
n=19 Participants
* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered \> 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
|
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
n=15 Participants
* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered \> 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
|
|---|---|---|---|---|
|
Age, Continuous
|
33.5 years
n=3 Participants
|
29 years
n=24 Participants
|
8 years
n=2 Participants
|
54 years
n=1 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=3 Participants
|
30 Participants
n=24 Participants
|
12 Participants
n=2 Participants
|
8 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=3 Participants
|
32 Participants
n=24 Participants
|
7 Participants
n=2 Participants
|
7 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=3 Participants
|
6 Participants
n=24 Participants
|
3 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=3 Participants
|
54 Participants
n=24 Participants
|
16 Participants
n=2 Participants
|
15 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=3 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=3 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=3 Participants
|
4 Participants
n=24 Participants
|
2 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=3 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=3 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=3 Participants
|
55 Participants
n=24 Participants
|
16 Participants
n=2 Participants
|
15 Participants
n=1 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=3 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=3 Participants
|
62 participants
n=24 Participants
|
19 participants
n=2 Participants
|
15 participants
n=1 Participants
|
PRIMARY outcome
Timeframe: Completion of all recipients through Day 0Population: Evaluability for outcome measure is for Pilot Pediatric/Young Adult Cohort only. One recipient was removed due to disease progression prior to infusion of CIML NK cells with SOC DLI.
-Feasibility is defined as the ability to generate and successfully infuse CIML NK cells with SOC donor lymphocyte infusion (DLI). Will be considered successful if doses above the minimum can be delivered in at least 18 of 24 patients. Target and minimum CIML doses are maximum capped at 20x10\^6/kg with a minimum dose of 0.5x10\^6 kg.
Outcome measures
| Measure |
Donors
On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
|
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
n=18 Participants
* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered \> 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
|
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered \> 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
|
|---|---|---|---|
|
Feasibility of Successfully Generating CIML NK Cells With Standard of Care (SOC) DLI From the Original Stem Cell Donor as Measured by the Number of Participants That Had Successful Doses Infused (Pilot Pediatric/Young Adult Cohort)
|
—
|
18 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to Day 100Population: Evaluability for outcome measure is for Pilot Pediatric/Young Adult Cohort only. One recipient was removed due to disease progression prior to infusion of CIML NK cells with SOC DLI.
Unexpected early mortality is defined as deaths that occur through day 100 that are possibly, probably, or definitely related to the study treatment.
Outcome measures
| Measure |
Donors
On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
|
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
n=18 Participants
* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered \> 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
|
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered \> 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
|
|---|---|---|---|
|
Safety of Administering CIML NK Cells Plus T Cell DLI as Measured by Number of Recipients With Unexpected Early Mortality (Pilot Pediatric/Young Adult Cohort)
|
—
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: From day 14 through month 6Population: Evaluability for outcome measure is for Pilot Pediatric/Young Adult Cohort only. One recipient was removed due to disease progression prior to infusion of CIML NK cells with SOC DLI.
Unacceptable GVHD is defined as grade IV acute GVHD as assessed by the Minnesota Grading Scale or grade D acute GVHD as assessed by the CIBMTR Grading Scale.
Outcome measures
| Measure |
Donors
On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
|
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
n=18 Participants
* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered \> 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
|
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered \> 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
|
|---|---|---|---|
|
Safety of Administering CIML NK Cells Plus T Cell DLI as Measured by Number of Recipients With Unacceptable Graft Versus Host Disease (GVHD) (Pilot Pediatric/Young Adult Cohort)
|
—
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: 8 weeks post CIML NK infusionPopulation: Evaluability for outcome measure is for Pilot Pediatric/Young Adult Cohort only. One recipient was removed due to disease progression prior to infusion of CIML NK cells with SOC DLI.
Prolonged neutropenia is defined as an absolute neutrophil count \<500/μL persisting for \> 2 weeks.
Outcome measures
| Measure |
Donors
On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
|
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
n=18 Participants
* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered \> 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
|
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered \> 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
|
|---|---|---|---|
|
Safety of Administering CIML NK Cells Plus T Cell DLI as Measured by Number of Recipients With Prolonged Neutropenia (Pilot Pediatric/Young Adult Cohort)
|
—
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to Day 100Population: Evaluability for outcome measure is for Phase 2 Adult Cohort only. One recipient withdrew prior to infusion of CIML NK cells with SOC DLI.
Unexpected early mortality is defined as deaths that occur through day 100 that are possibly, probably, or definitely related to the study treatment.
Outcome measures
| Measure |
Donors
On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
|
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered \> 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
|
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
n=14 Participants
* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered \> 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
|
|---|---|---|---|
|
Safety of Administering CIML NK Cells Plus T Cell DLI as Measured by Number of Recipients With Unexpected Early Mortality (Phase 2 Adult Cohort)
|
—
|
—
|
1 Participants
|
PRIMARY outcome
Timeframe: From day 14 through month 6Population: Evaluability for outcome measure is for Phase 2 Adult Cohort only. One recipient withdrew prior to infusion of CIML NK cells with SOC DLI.
Unacceptable GVHD is defined as grade IV acute GVHD as assessed by the Minnesota Grading Scale or grade D acute GVHD as assessed by the CIBMTR Grading Scale.
Outcome measures
| Measure |
Donors
On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
|
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered \> 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
|
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
n=14 Participants
* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered \> 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
|
|---|---|---|---|
|
Safety of Administering CIML NK Cells Plus T Cell DLI as Measured by Number of Recipients With Unacceptable GVHD (Phase 2 Adult Cohort)
|
—
|
—
|
1 Participants
|
PRIMARY outcome
Timeframe: 8 weeks post CIML NK infusionPopulation: Evaluability for outcome measure is for Phase 2 Adult Cohort only. One recipient withdrew prior to infusion of CIML NK cells with SOC DLI.
Prolonged neutropenia is defined as an absolute neutrophil count \<500/μL persisting for \> 2 weeks.
Outcome measures
| Measure |
Donors
On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
|
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered \> 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
|
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
n=14 Participants
* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered \> 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
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|---|---|---|---|
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Safety of Administering CIML NK Cells Plus T Cell DLI as Measured by Number of Recipients With Prolonged Neutropenia (Phase 2 Adult Cohort)
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—
|
—
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Evaluability for outcome measure is for Phase 2 Adult Cohort only and only includes those who achieved CR/CRi.
-LFS is defined as the time from achievement of CR/CRi to the time of relapse, death in remission, or last follow-up.
Outcome measures
| Measure |
Donors
On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
|
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
n=5 Participants
* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered \> 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
|
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered \> 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
|
|---|---|---|---|
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Kaplan-Meier Estimate of Percentage of Participants With Leukemia-Free Survival (LFS) (Phase 2 Adult Cohort)
|
—
|
20.000 percentage of participants-Kaplan Meier
Interval 0.837 to 58.185
|
—
|
SECONDARY outcome
Timeframe: Day 30Population: Evaluability for outcome measure is for Pilot Pediatric/Young Adult Cohort only. One recipient was removed due to disease progression prior to infusion of CIML NK cells with SOC DLI.
* Complete remission (CR):Morphologically leukemia free state (i.e. bone marrow with \<5% blasts by morphologic criteria and no blasts with Auer rods, no evidence of extramedullary leukemia) and absolute neutrophil count ≥1000 /μL and platelets ≥100,000 /μL. Patient must be independent of transfusions * Complete remission with incomplete blood count recover (CRi): All of the above criteria for CR must be met, except that absolute neutrophils \<1000 /μL or platelets \<100,000 /μL in the blood.
Outcome measures
| Measure |
Donors
On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
|
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
n=18 Participants
* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered \> 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
|
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered \> 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
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|---|---|---|---|
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Complete Remission Rate (CR/CRi) (Pilot Pediatric/Young Adult Cohort)
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—
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8 Participants
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—
|
SECONDARY outcome
Timeframe: Day 30Population: Evaluability for outcome measure is for Phase 2 Adult Cohort only. One recipient withdrew prior to infusion of CIML NK cells with SOC DLI.
* Complete remission (CR):Morphologically leukemia free state (i.e. bone marrow with \<5% blasts by morphologic criteria and no blasts with Auer rods, no evidence of extramedullary leukemia) and absolute neutrophil count ≥1000 /μL and platelets ≥100,000 /μL. Patient must be independent of transfusions * Complete remission with incomplete blood count recover (CRi): All of the above criteria for CR must be met, except that absolute neutrophils \<1000 /μL or platelets \<100,000 /μL in the blood.
Outcome measures
| Measure |
Donors
On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
|
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
n=14 Participants
* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered \> 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
|
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered \> 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
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|---|---|---|---|
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Complete Remission Rate (CR/CRi) (Phase 2 Adult Cohort)
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—
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5 Participants
|
—
|
SECONDARY outcome
Timeframe: 100 days post CIML NK cell infusionPopulation: Evaluability for outcome measure is for Pilot Pediatric/Young Adult Cohort only and only includes those who achieved CR/CRi.
-LFS is defined as the time from achievement of CR/CRi to the time of relapse, death in remission, or last follow-up.
Outcome measures
| Measure |
Donors
On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
|
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
n=8 Participants
* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered \> 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
|
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered \> 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
|
|---|---|---|---|
|
Kaplan-Meier Estimate of Percentage of Participants With Leukemia-Free Survival (LFS) (Pilot Pediatric/Young Adult Cohort)
|
—
|
57.143 percentage of participants-Kaplan Meier
Interval 17.187 to 83.708
|
—
|
SECONDARY outcome
Timeframe: 1 year post CIML NK cell infusionPopulation: Evaluability for outcome measure is for Pilot Pediatric/Young Adult Cohort only and only includes those who achieved CR/CRi.
-LFS is defined as the time from achievement of CR/CRi to the time of relapse, death in remission, or last follow-up.
Outcome measures
| Measure |
Donors
On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
|
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
n=8 Participants
* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered \> 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
|
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered \> 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
|
|---|---|---|---|
|
Kaplan-Meier Estimate of Percentage of Participants With Leukemia-Free Survival (LFS) (Pilot Pediatric/Young Adult Cohort)
|
—
|
28.571 percentage of participants-Kaplan Meier
Interval 4.113 to 61.151
|
—
|
SECONDARY outcome
Timeframe: 100 days post CIML NK cell infusionPopulation: Evaluability for outcome measure is for Phase 2 Adult Cohort only and only includes those who achieved CR/CRi.
-LFS is defined as the time from achievement of CR/CRi to the time of relapse, death in remission, or last follow-up.
Outcome measures
| Measure |
Donors
On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
|
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
n=5 Participants
* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered \> 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
|
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered \> 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
|
|---|---|---|---|
|
Kaplan-Meier Estimate of Percentage of Participants With Leukemia-Free Survival (LFS) (Phase 2 Adult Cohort)
|
—
|
40.000 percentage of participants-Kaplan Meier
Interval 5.198 to 75.282
|
—
|
SECONDARY outcome
Timeframe: 1 year post CIML NK cell infusionPopulation: Evaluability for outcome measure is for Phase 2 Adult Cohort only and only includes those who achieved CR/CRi.
-LFS is defined as the time from achievement of CR/CRi to the time of relapse, death in remission, or last follow-up.
Outcome measures
| Measure |
Donors
On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
|
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
n=5 Participants
* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered \> 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
|
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered \> 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
|
|---|---|---|---|
|
Kaplan-Meier Estimate of Percentage of Participants With Leukemia-Free Survival (LFS) (Phase 2 Adult Cohort)
|
—
|
20.000 percentage of participants-Kaplan Meier
Interval 0.837 to 58.185
|
—
|
SECONDARY outcome
Timeframe: 100 days post CIML NK cell infusionPopulation: Evaluability for outcome measure is for Pilot Pediatric/Young Adult Cohort only. One recipient was removed due to disease progression prior to infusion of CIML NK cells with SOC DLI.
-OS is defined as the time from the date of Day 0 until death from any cause.
Outcome measures
| Measure |
Donors
On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
|
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
n=18 Participants
* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered \> 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
|
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered \> 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
|
|---|---|---|---|
|
Kaplan-Meier Estimate of Percentage of Participants With Overall Survival (OS) (Pilot Pediatric/Young Adult Cohort)
|
—
|
83.333 percentage of participants-Kaplan Meier
Interval 56.769 to 94.298
|
—
|
SECONDARY outcome
Timeframe: 1 year post CIML NK cell infusionPopulation: Evaluability for outcome measure is for Pilot Pediatric/Young Adult Cohort only. One recipient was removed due to disease progression prior to infusion of CIML NK cells with SOC DLI.
-OS is defined as the time from the date of Day 0 until death from any cause.
Outcome measures
| Measure |
Donors
On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
|
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
n=18 Participants
* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered \> 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
|
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered \> 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
|
|---|---|---|---|
|
Kaplan-Meier Estimate of Percentage of Participants With Overall Survival (OS) (Pilot Pediatric/Young Adult Cohort)
|
—
|
33.333 percentage of participants-Kaplan Meier
Interval 13.653 to 54.545
|
—
|
SECONDARY outcome
Timeframe: 100 days post CIML NK cell infusionPopulation: Evaluability for outcome measure is for Phase 2 Adult Cohort only. One recipient withdrew prior to infusion of CIML NK cells with SOC DLI.
-OS is defined as the time from the date of Day 0 until death from any cause.
Outcome measures
| Measure |
Donors
On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
|
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
n=14 Participants
* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered \> 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
|
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered \> 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
|
|---|---|---|---|
|
Kaplan-Meier Estimate of Percentage of Participants With Overall Survival (OS) (Phase 2 Adult Cohort)
|
—
|
42.857 percentage of participants-Kaplan Meier
Interval 17.727 to 66.037
|
—
|
SECONDARY outcome
Timeframe: 1 year post CIML NK cell infusionPopulation: Evaluability for outcome measure is for Phase 2 Adult Cohort only. One recipient withdrew prior to infusion of CIML NK cells with SOC DLI.
-OS is defined as the time from the date of Day 0 until death from any cause.
Outcome measures
| Measure |
Donors
On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
|
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
n=14 Participants
* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered \> 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
|
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered \> 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
|
|---|---|---|---|
|
Kaplan-Meier Estimate of Percentage of Participants With Overall Survival (OS) (Phase 2 Adult Cohort)
|
—
|
7.143 percentage of participants-Kaplan Meier
Interval 0.452 to 27.523
|
—
|
SECONDARY outcome
Timeframe: Day 14 through 6 monthsPopulation: Evaluability for outcome measure is for Pilot Pediatric/Young Adult Cohort only. One recipient was removed due to disease progression prior to infusion of CIML NK cells with SOC DLI.
* Incidence and severity of acute GVHD will be assessed based on the Minnesota grading scale. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s). * The Minnesota Grading scale is graded with I, II, III, IV. Grade I is the least severe and Grade IV is the most severe.
Outcome measures
| Measure |
Donors
On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
|
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
n=18 Participants
* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered \> 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
|
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered \> 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
|
|---|---|---|---|
|
Incidence and Severity of Acute GVHD Rates as Assessed on the Minnesota Grading Scale (Pilot Pediatric/Young Adult Cohort)
None
|
—
|
16 Participants
|
—
|
|
Incidence and Severity of Acute GVHD Rates as Assessed on the Minnesota Grading Scale (Pilot Pediatric/Young Adult Cohort)
Grade I
|
—
|
0 Participants
|
—
|
|
Incidence and Severity of Acute GVHD Rates as Assessed on the Minnesota Grading Scale (Pilot Pediatric/Young Adult Cohort)
Grade II
|
—
|
1 Participants
|
—
|
|
Incidence and Severity of Acute GVHD Rates as Assessed on the Minnesota Grading Scale (Pilot Pediatric/Young Adult Cohort)
Grade III
|
—
|
1 Participants
|
—
|
|
Incidence and Severity of Acute GVHD Rates as Assessed on the Minnesota Grading Scale (Pilot Pediatric/Young Adult Cohort)
Grade IV
|
—
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 14 through 6 monthsPopulation: Evaluability for outcome measure is for Pilot Pediatric/Young Adult Cohort only. One recipient was removed due to disease progression prior to infusion of CIML NK cells with SOC DLI.
* Incidence and severity of acute GVHD will be assessed based on the CIBMTR grading scale. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s). * The CIBMTR grading scale is graded with A, B, C, or D. Grade A is considered the least severe with Grade D being the most severe.
Outcome measures
| Measure |
Donors
On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
|
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
n=18 Participants
* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered \> 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
|
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered \> 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
|
|---|---|---|---|
|
Incidence and Severity of Acute GVHD Rates as Assessed on the CIBMTR Grading Scale (Pilot Pediatric/Young Adult Cohort)
None
|
—
|
16 Participants
|
—
|
|
Incidence and Severity of Acute GVHD Rates as Assessed on the CIBMTR Grading Scale (Pilot Pediatric/Young Adult Cohort)
Grade A
|
—
|
0 Participants
|
—
|
|
Incidence and Severity of Acute GVHD Rates as Assessed on the CIBMTR Grading Scale (Pilot Pediatric/Young Adult Cohort)
Grade B
|
—
|
1 Participants
|
—
|
|
Incidence and Severity of Acute GVHD Rates as Assessed on the CIBMTR Grading Scale (Pilot Pediatric/Young Adult Cohort)
Grade C
|
—
|
1 Participants
|
—
|
|
Incidence and Severity of Acute GVHD Rates as Assessed on the CIBMTR Grading Scale (Pilot Pediatric/Young Adult Cohort)
Grade D
|
—
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 100 through 12 monthsPopulation: Evaluability for outcome measure is for Pilot Pediatric/Young Adult Cohort only. One recipient was removed due to disease progression prior to infusion of CIML NK cells with SOC DLI. 8 recipients were not evaluable as they were removed prior to any chronic GVHD assessments.
* Incidence and severity of chronic GVHD will be assessed based on the NIH consensus criteria and global severity scoring system. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s). * Severity is graded with mild, moderate, or severe chronic GVHD.
Outcome measures
| Measure |
Donors
On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
|
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
n=10 Participants
* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered \> 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
|
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered \> 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
|
|---|---|---|---|
|
Incidence and Severity of Chronic GVHD Rates (Pilot Pediatric/Young Adult Cohort)
None
|
—
|
9 Participants
|
—
|
|
Incidence and Severity of Chronic GVHD Rates (Pilot Pediatric/Young Adult Cohort)
Mild
|
—
|
0 Participants
|
—
|
|
Incidence and Severity of Chronic GVHD Rates (Pilot Pediatric/Young Adult Cohort)
Moderate
|
—
|
1 Participants
|
—
|
|
Incidence and Severity of Chronic GVHD Rates (Pilot Pediatric/Young Adult Cohort)
Severe
|
—
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 14 through 6 monthsPopulation: Evaluability for outcome measure is for Phase 2 Adult Cohort only. One recipient withdrew prior to infusion of CIML NK cells with SOC DLI.
* Incidence and severity of acute GVHD will be assessed based on the CIBMTR grading scale. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s). * The Minnesota Grading scale is graded with I, II, III, IV. Grade I is the least severe and Grade IV is the most severe.
Outcome measures
| Measure |
Donors
On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
|
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered \> 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
|
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
n=14 Participants
* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered \> 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
|
|---|---|---|---|
|
Incidence and Severity of Acute GVHD Rates as Assessed on the Minnesota Grading Scale (Phase 2 Adult Cohort)
None
|
—
|
—
|
11 Participants
|
|
Incidence and Severity of Acute GVHD Rates as Assessed on the Minnesota Grading Scale (Phase 2 Adult Cohort)
Grade I
|
—
|
—
|
0 Participants
|
|
Incidence and Severity of Acute GVHD Rates as Assessed on the Minnesota Grading Scale (Phase 2 Adult Cohort)
Grade II
|
—
|
—
|
1 Participants
|
|
Incidence and Severity of Acute GVHD Rates as Assessed on the Minnesota Grading Scale (Phase 2 Adult Cohort)
Grade III
|
—
|
—
|
1 Participants
|
|
Incidence and Severity of Acute GVHD Rates as Assessed on the Minnesota Grading Scale (Phase 2 Adult Cohort)
Grade IV
|
—
|
—
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 14 through 6 monthsPopulation: Evaluability for outcome measure is for Phase 2 Adult Cohort only. One recipient withdrew prior to infusion of CIML NK cells with SOC DLI.
* Incidence and severity of acute GVHD will be assessed based on the CIBMTR grading scale. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s). * The CIBMTR grading scale is graded with A, B, C, or D. Grade A is considered the least severe with Grade D being the most severe.
Outcome measures
| Measure |
Donors
On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
|
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered \> 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
|
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
n=14 Participants
* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered \> 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
|
|---|---|---|---|
|
Incidence and Severity of Acute GVHD Rates as Assessed on the CIBMTR Grading Scale (Phase 2 Adult Cohort)
None
|
—
|
—
|
11 Participants
|
|
Incidence and Severity of Acute GVHD Rates as Assessed on the CIBMTR Grading Scale (Phase 2 Adult Cohort)
Grade A
|
—
|
—
|
0 Participants
|
|
Incidence and Severity of Acute GVHD Rates as Assessed on the CIBMTR Grading Scale (Phase 2 Adult Cohort)
Grade B
|
—
|
—
|
0 Participants
|
|
Incidence and Severity of Acute GVHD Rates as Assessed on the CIBMTR Grading Scale (Phase 2 Adult Cohort)
Grade C
|
—
|
—
|
2 Participants
|
|
Incidence and Severity of Acute GVHD Rates as Assessed on the CIBMTR Grading Scale (Phase 2 Adult Cohort)
Grade D
|
—
|
—
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 100 through 12 monthsPopulation: Evaluability for outcome measure is for Phase 2 Adult Cohort only. One recipient withdrew prior to infusion of CIML NK cells with SOC DLI. 12 recipients were not evaluable as they were removed prior to any chronic GVHD assessments.
* Incidence and severity of chronic GVHD will be assessed based on the NIH consensus criteria and global severity scoring system. Attempts should be made to confirm the diagnosis pathologically by biopsy of target organ(s). * Severity is graded with mild, moderate, or severe chronic GVHD.
Outcome measures
| Measure |
Donors
On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
|
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered \> 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
|
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
n=1 Participants
* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered \> 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
|
|---|---|---|---|
|
Incidence and Severity of Chronic GVHD Rates (Phase 2 Adult Cohort)
None
|
—
|
—
|
1 Participants
|
|
Incidence and Severity of Chronic GVHD Rates (Phase 2 Adult Cohort)
Mild
|
—
|
—
|
0 Participants
|
|
Incidence and Severity of Chronic GVHD Rates (Phase 2 Adult Cohort)
Moderate
|
—
|
—
|
0 Participants
|
|
Incidence and Severity of Chronic GVHD Rates (Phase 2 Adult Cohort)
Severe
|
—
|
—
|
0 Participants
|
Adverse Events
Donors
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
Serious events: 5 serious events
Other events: 19 other events
Deaths: 14 deaths
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
Serious events: 10 serious events
Other events: 15 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Donors
n=28 participants at risk
On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
|
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
n=19 participants at risk
* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered \> 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
|
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
n=15 participants at risk
* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered \> 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemmorhage
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
General disorders
Acute GvHD
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
General disorders
Death due to acute GvHD
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
General disorders
Fever
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
General disorders
Infusion related reaction
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
General disorders
Multi-organ failure
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Infections and infestations
Lung infection
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Infections and infestations
RSV+
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Infections and infestations
Sepsis
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
13.3%
2/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death due to disease progression
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
21.1%
4/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
40.0%
6/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
26.7%
4/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
Other adverse events
| Measure |
Donors
n=28 participants at risk
On Day -2 or -1, peripheral blood mononuclear cells will be collected by a standard apheresis over 4-5 hours (with a target volume of at least 20 L for patients ≥ 18 years of age) from the same donor that provided the HCT graft. For related local donors, apheresis will occur on Day -1. For unrelated donors, apheresis will occur on Day -2 or -1, with the goal of processing the product into T cell and NK cells on Day -1. The dose of the DLI will be 1x106 CD3+/kg the first cycle in the pediatric cohort, and follow institutional practices for the adult cohort and for subsequent cycles in the pediatric cohort.
|
CIML NK Cell After T Cell DLI (Pilot Pediatric/Young Adult Cohort)
n=19 participants at risk
* Recipients will receive standard of care salvage chemotherapy with FLAG (fludarabine, ara-C and G-CSF) or decitabine 2-4 weeks prior to receiving the DLI on day -1 and CIML NK cell infusion on day 0.
* A second cycle of therapy may be administered \> 30 days after the administration of the first course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the inclusion/exclusion criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the first cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered.
|
CIML NK Cell After T Cell DLI (Phase 2 Adult Cohort)
n=15 participants at risk
* Recipients will receive lymphodepleting therapy with fludarabine and cyclophosphamide on days -7 through -3 prior to receiving CIML NK cell infusion on day 0. DLI will be given on day 30. rh IL-2 will be administered beginning on Day 0, continuing every other day through Day + 12. Note that the addition of IL-2 started with the 7th recipient treated.
* A 2nd cycle of therapy may be administered \> 30 days after the administration of the 1st course of protocol therapy to maintain response or to treat persistent/relapsed AML, if a patient continues to meet the eligibility criteria. Chemotherapy may be omitted before a second infusion of DLI and CIML NK cells. In the setting of GVHD following the 1st cycle of therapy, the T cell DLI may be omitted, and ML NK cells administered. The date of the 2nd NK cell infusion will be considered a 2nd Day 0.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
36.8%
7/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
46.7%
7/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
13.3%
2/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
15.8%
3/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
20.0%
3/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
36.8%
7/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
26.7%
4/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
15.8%
3/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
13.3%
2/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
15.8%
3/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
52.6%
10/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
66.7%
10/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
10.5%
2/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
20.0%
3/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
47.4%
9/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
40.0%
6/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
31.6%
6/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
33.3%
5/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Metabolism and nutrition disorders
Iron overload
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Musculoskeletal and connective tissue disorders
Ankle instability
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
31.6%
6/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
33.3%
5/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Musculoskeletal and connective tissue disorders
Bone infarct
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
10.5%
2/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
26.7%
4/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
13.3%
2/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
13.3%
2/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
31.6%
6/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
13.3%
2/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Nervous system disorders
Altered mental status
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
40.0%
6/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Nervous system disorders
Facial muscle weakness
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Nervous system disorders
Headache
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
31.6%
6/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
33.3%
5/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Nervous system disorders
Insomnia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
20.0%
3/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Nervous system disorders
Movements involuntary
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
13.3%
2/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Nervous system disorders
Syncope
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Nervous system disorders
Tremor
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
10.5%
2/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
20.0%
3/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
13.3%
2/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
13.3%
2/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Psychiatric disorders
Depression
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Renal and urinary disorders
Burn with urination
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Renal and urinary disorders
Enlarged kidneys
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
10.5%
2/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
46.7%
7/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Renal and urinary disorders
Incomplete urination
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
26.7%
4/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
20.0%
3/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
20.0%
3/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Reproductive system and breast disorders
Mennorhagia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
13.3%
2/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
15.8%
3/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
26.7%
4/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
40.0%
6/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
40.0%
6/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
15.8%
3/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
40.0%
6/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
15.8%
3/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
15.8%
3/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
13.3%
2/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
15.8%
3/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
26.7%
4/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
15.8%
3/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
13.3%
2/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Respiratory, thoracic and mediastinal disorders
Transfusion associated circulatory overload
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
20.0%
3/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Skin and subcutaneous tissue disorders
Diaper dermatitis
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
10.5%
2/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Skin and subcutaneous tissue disorders
Erosion/scratch
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Skin and subcutaneous tissue disorders
Erythema at G tube site
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
57.9%
11/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
13.3%
2/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
10.5%
2/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
13.3%
2/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Cardiac disorders
Dilated coronary arteries
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Cardiac disorders
Dilated left ventricle
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
10.5%
2/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
10.5%
2/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
20.0%
3/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
15.8%
3/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
60.0%
9/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Ear and labyrinth disorders
Mastoid effusion
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Eye disorders
Blurred vision
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Eye disorders
Dry eye
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Eye disorders
Subconjunctival hemorrhage
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
36.8%
7/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
13.3%
2/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Anal mucositis
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Anal pain
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
13.3%
2/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Bleeding gums
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
10.5%
2/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
13.3%
2/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
10.5%
2/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
46.7%
7/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
36.8%
7/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
46.7%
7/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
13.3%
2/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
13.3%
2/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Frequent solid bowel movements
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Gagging
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Hematemesis
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
13.3%
2/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Jaw pain
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Mouth sore
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
10.5%
2/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
10.5%
2/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
26.7%
4/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
26.3%
5/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
40.0%
6/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Oral lesion
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
21.1%
4/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Oral plaque
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Small intestinal mucositis
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
31.6%
6/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
20.0%
3/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
General disorders
Chills
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
57.9%
11/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
73.3%
11/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
General disorders
Diffuse pain
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
General disorders
Edema face
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
General disorders
Edema limbs
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
73.3%
11/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
General disorders
Facial pain
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
General disorders
Fatigue
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
21.1%
4/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
66.7%
10/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
General disorders
Fever
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
57.9%
11/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
13.3%
2/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
General disorders
Flu like symptoms
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
13.3%
2/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
General disorders
Fluid overload
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
General disorders
Gait disturbance
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
10.5%
2/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
General disorders
Infusion related reaction
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
10.5%
2/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
General disorders
Injection site reaction
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
26.7%
4/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
General disorders
Irritability
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
31.6%
6/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
General disorders
Localized edema
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
15.8%
3/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
General disorders
Malaise
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
20.0%
3/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
20.0%
3/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
General disorders
Oroantral fistula
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
General disorders
Overdose of controlled substance
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
General disorders
Pain
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
10.5%
2/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
20.0%
3/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
General disorders
Post sedation sickness
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
13.3%
2/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Infections and infestations
Bacteremia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Infections and infestations
Bacteremia - Staphylococcus epidermidis (MRSE)
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Infections and infestations
C-difficile colitis
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Infections and infestations
C. difficile
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Infections and infestations
CMV infection
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Infections and infestations
Candida krusel fungal
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Infections and infestations
E. Faecium bacteremia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Infections and infestations
Epstein-Barr virus
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Infections and infestations
Lung infection
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
20.0%
3/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Infections and infestations
MRSE + blood bacteremia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Infections and infestations
Oral thrush
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Infections and infestations
Parainfluenza
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Infections and infestations
Salivary gland infection
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
13.3%
2/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Infections and infestations
Skin infection
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
26.3%
5/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
33.3%
5/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
33.3%
5/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
15.8%
3/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
26.7%
4/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
47.4%
9/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
46.7%
7/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
15.8%
3/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
46.7%
7/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
47.4%
9/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
53.3%
8/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
21.1%
4/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
46.7%
7/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
13.3%
2/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Investigations
Creatinine increased
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
26.7%
4/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
26.7%
4/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Investigations
Fibrinogen decreased
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Investigations
GGT increased
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
42.1%
8/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Investigations
INR increased
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
26.7%
4/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Investigations
Lipase increased
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
10.5%
2/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
20.0%
3/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
13.3%
2/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Investigations
Platelet count decreased
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
31.6%
6/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
20.0%
3/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Investigations
Weight loss
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
15.8%
3/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
13.3%
2/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Investigations
White blood cell decreased
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
10.5%
2/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
13.3%
2/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
21.1%
4/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
73.3%
11/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
10.5%
2/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
20.0%
3/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Skin and subcutaneous tissue disorders
Lesion on arm
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
10.5%
2/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
15.8%
3/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
15.8%
3/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
31.6%
6/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
33.3%
5/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Skin and subcutaneous tissue disorders
Red lump
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Skin and subcutaneous tissue disorders
Scaling of scalp
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
20.0%
3/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Vascular disorders
Hematoma
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
5.3%
1/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
6.7%
1/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Vascular disorders
Hypertension
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
21.1%
4/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
60.0%
9/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Vascular disorders
Hypotension
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
36.8%
7/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
46.7%
7/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
|
Vascular disorders
Kawasaki Disease
|
0.00%
0/28 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
10.5%
2/19 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
0.00%
0/15 • - Adverse events for recipients were collected from start of treatment through 100 days after the last CIML NK cell infusion. From 100 days-48 months, targeted collection of grade 3/4 AEs related to study therapy that encompass hematologic AEs, infection, or GVHD. - All-cause mortality for recipients was collected from start of treatment through completion of follow-up (up to 48 months). - Adverse events and all-cause mortality for donors were collected on the day of leukapheresis.
|
Additional Information
Dr. Amanda Cashen
Washington University School of Medicine
Phone: 314-454-8323
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place