Trial Outcomes & Findings for FT538 in Combination With Daratumumab in AML Acute Myeloid Leukemia (NCT NCT04714372)
NCT ID: NCT04714372
Last Updated: 2024-10-24
Results Overview
Dose limiting toxicity (DLT) is defined as any AE (based on CTCAE v5) that is at least possibly related to FT538 that occurs after the first FT538 infusion through the end of the DLT assessment period on Day 29 as defined below: Any Grade 4 non-hematologic AE, Grade 3 pulmonary or cardiac AE of any duration, Grade 3 immune cell associated neurotoxicity syndrome (ICANS) of any duration, Any other Grade 3 non-hematologic AE of \>72 hours duration or Grade ≥2 acute GvHD requiring systemic steroid administration
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
42 days from the 1st FT538 infusion
Results posted on
2024-10-24
Participant Flow
Participant milestones
| Measure |
Dose Level 1: FT538 at 1 x10^8 Cells/Dose
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 2: FT538 at 3 x10^8 Cells/Dose
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 3: FT538 at 1 x10^9 Cells/Dose
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 4: FT538 at 1.5 x10^9 Cells/Dose
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
6
|
|
Overall Study
COMPLETED
|
1
|
1
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
FT538 in Combination With Daratumumab in AML Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Dose Level 1: FT538 at 1 x10^8 Cells/Dose
n=1 Participants
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 2: FT538 at 3 x10^8 Cells/Dose
n=1 Participants
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 3: FT538 at 1 x10^9 Cells/Dose
n=1 Participants
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 4: FT538 at 1.5 x10^9 Cells/Dose
n=6 Participants
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
6 participants
n=7 Participants
|
9 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 42 days from the 1st FT538 infusionDose limiting toxicity (DLT) is defined as any AE (based on CTCAE v5) that is at least possibly related to FT538 that occurs after the first FT538 infusion through the end of the DLT assessment period on Day 29 as defined below: Any Grade 4 non-hematologic AE, Grade 3 pulmonary or cardiac AE of any duration, Grade 3 immune cell associated neurotoxicity syndrome (ICANS) of any duration, Any other Grade 3 non-hematologic AE of \>72 hours duration or Grade ≥2 acute GvHD requiring systemic steroid administration
Outcome measures
| Measure |
Dose Level 1: FT538 at 1 x10^8 Cells/Dose
n=1 Participants
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 2: FT538 at 3 x10^8 Cells/Dose
n=1 Participants
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 3: FT538 at 1 x10^9 Cells/Dose
n=1 Participants
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 4: FT538 at 1.5 x10^9 Cells/Dose
n=6 Participants
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Dose Limiting Toxicity (DLT) Events
|
0 Count of Participants
Interval 0.0 to 0.89
|
0 Count of Participants
Interval 0.0 to 0.89
|
0 Count of Participants
Interval 0.0 to 0.89
|
0 Count of Participants
Interval 0.0 to 0.31
|
SECONDARY outcome
Timeframe: 28 days from the 1st FT538 infusionEfficacy of treatment is measured by the objective response rate (Complete Remission \[CR\] + Complete Remission with Incomplete Hematologic Recovery \[CRi\]) assessed by Day 28 based on the 2017 European LeukemiaNet (ELN) response criteria CR - defined as bone marrow blast \<5%, absence of circulating blasts and blasts with auer rods, absence of extramedullary disease, Absolute neutrophil count \>= 1.0 × 10e9/L (1000/μL) and platelet count \>=100 × 10e9/L 100,000/μL) CRi - defined as all CR criterial except for residual neutropenia (\<1.0 × 10e9/L \[1000/μL\]) or thrombocytopenia (\<100 × 10e9/L \[100,000/μL\])
Outcome measures
| Measure |
Dose Level 1: FT538 at 1 x10^8 Cells/Dose
n=1 Participants
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 2: FT538 at 3 x10^8 Cells/Dose
n=1 Participants
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 3: FT538 at 1 x10^9 Cells/Dose
n=1 Participants
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 4: FT538 at 1.5 x10^9 Cells/Dose
n=6 Participants
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
|---|---|---|---|---|
|
Number of Participants Achieving Complete Remission (CR + CRi)
|
0 Count of Participants
Interval 0.0 to 0.89
|
0 Count of Participants
Interval 0.0 to 0.89
|
0 Count of Participants
Interval 0.0 to 0.89
|
2 Count of Participants
Interval 0.72 to 3.9
|
SECONDARY outcome
Timeframe: 12 months from the 1st FT538 infusionOverall response rate is defined as number of patients who have a partial or complete response to therapy divided by the total number of patients who received treatment. Response criteria will be based on 2017 European LeukemiaNet (ELN) response criteria assessing the bone marrow blast percentage, presence/absence of circulating blasts, presence/absence of blasts with auer rods, presence/absence of extramedullary disease, Absolute neutrophil counts per liter pf blood and platelet counts per liter blood
Outcome measures
| Measure |
Dose Level 1: FT538 at 1 x10^8 Cells/Dose
n=1 Participants
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 2: FT538 at 3 x10^8 Cells/Dose
n=1 Participants
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 3: FT538 at 1 x10^9 Cells/Dose
n=1 Participants
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 4: FT538 at 1.5 x10^9 Cells/Dose
n=6 Participants
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
|---|---|---|---|---|
|
Overall Response Rate
|
0 participants
Interval 0.0 to 0.89
|
0 participants
Interval 0.0 to 0.89
|
0 participants
Interval 0.0 to 0.89
|
2 participants
Interval 0.72 to 3.9
|
SECONDARY outcome
Timeframe: 12 months from the 1st FT538 infusionPercentage of participants experiencing progression free survival at one year follow up
Outcome measures
| Measure |
Dose Level 1: FT538 at 1 x10^8 Cells/Dose
n=1 Participants
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 2: FT538 at 3 x10^8 Cells/Dose
n=1 Participants
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 3: FT538 at 1 x10^9 Cells/Dose
n=1 Participants
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 4: FT538 at 1.5 x10^9 Cells/Dose
n=6 Participants
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
|---|---|---|---|---|
|
Percentage of Participants With Progression Free Survival (PFS)
|
0 Percentage of participants
Interval 0.0 to 0.89
|
100 Percentage of participants
Interval 0.1 to 100.0
|
0 Percentage of participants
Interval 0.0 to 0.89
|
33 Percentage of participants
Interval 12.0 to 65.0
|
SECONDARY outcome
Timeframe: 12 months from the 1st FT538 infusionPercentage of participants with Overall Survival (OS) at one year follow up
Outcome measures
| Measure |
Dose Level 1: FT538 at 1 x10^8 Cells/Dose
n=1 Participants
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 2: FT538 at 3 x10^8 Cells/Dose
n=1 Participants
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 3: FT538 at 1 x10^9 Cells/Dose
n=1 Participants
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 4: FT538 at 1.5 x10^9 Cells/Dose
n=6 Participants
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
|---|---|---|---|---|
|
Percentage of Participants With Overall Survival (OS)
|
0 Percentage of participants
Interval 0.0 to 0.89
|
100 Percentage of participants
Interval 0.1 to 100.0
|
0 Percentage of participants
Interval 0.0 to 0.89
|
33 Percentage of participants
Interval 12.0 to 65.0
|
SECONDARY outcome
Timeframe: 12 months from the 1st FT538 infusionNumber of participants experiencing adverse events with the combination of Daratumumab and FT538
Outcome measures
| Measure |
Dose Level 1: FT538 at 1 x10^8 Cells/Dose
n=1 Participants
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 2: FT538 at 3 x10^8 Cells/Dose
n=1 Participants
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 3: FT538 at 1 x10^9 Cells/Dose
n=1 Participants
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 4: FT538 at 1.5 x10^9 Cells/Dose
n=6 Participants
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Adverse Events
|
1 Count of Participants
|
1 Count of Participants
|
1 Count of Participants
|
6 Count of Participants
|
Adverse Events
Dose Level 1: FT538 at 1 x10^8 Cells/Dose
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Dose Level 2: FT538 at 3 x10^8 Cells/Dose
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose Level 3: FT538 at 1 x10^9 Cells/Dose
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Dose Level 4: FT538 at 1.5 x10^9 Cells/Dose
Serious events: 5 serious events
Other events: 6 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Dose Level 1: FT538 at 1 x10^8 Cells/Dose
n=1 participants at risk
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 2: FT538 at 3 x10^8 Cells/Dose
n=1 participants at risk
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 3: FT538 at 1 x10^9 Cells/Dose
n=1 participants at risk
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 4: FT538 at 1.5 x10^9 Cells/Dose
n=6 participants at risk
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other, specify - Disease progression
|
100.0%
1/1 • Number of events 2 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
2/6 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Typhlitis
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Investigations
Choledocolithiasis
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholecystitis
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 2 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Febrile neutropenia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
50.0%
3/6 • Number of events 3 • 1 year
|
|
Cardiac disorders
Heart failure
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Dose Level 1: FT538 at 1 x10^8 Cells/Dose
n=1 participants at risk
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 2: FT538 at 3 x10^8 Cells/Dose
n=1 participants at risk
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 3: FT538 at 1 x10^9 Cells/Dose
n=1 participants at risk
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
Dose Level 4: FT538 at 1.5 x10^9 Cells/Dose
n=6 participants at risk
FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
Daratumumab/rHuPH20: Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538: FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
Fludarabine: Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
Cyclophosphamide: Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • Number of events 2 • 1 year
|
100.0%
1/1 • Number of events 3 • 1 year
|
0.00%
0/1 • 1 year
|
50.0%
3/6 • Number of events 3 • 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
100.0%
1/1 • Number of events 1 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
50.0%
3/6 • Number of events 4 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Cardiac disorders
Heart failure
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Cardiac disorders
Sinus tachycardia
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Ear and labyrinth disorders
Hearing impaired
|
100.0%
1/1 • Number of events 2 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 2 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
2/6 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
1/1 • Number of events 2 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
66.7%
4/6 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
2/6 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 2 • 1 year
|
0.00%
0/1 • 1 year
|
66.7%
4/6 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
Typhlitis
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 3 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 3 • 1 year
|
0.00%
0/1 • 1 year
|
66.7%
4/6 • Number of events 4 • 1 year
|
|
General disorders
Chills
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
General disorders
Edema limbs
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
66.7%
4/6 • Number of events 6 • 1 year
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 2 • 1 year
|
33.3%
2/6 • Number of events 3 • 1 year
|
|
General disorders
Fever
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 2 • 1 year
|
0.00%
0/1 • 1 year
|
50.0%
3/6 • Number of events 3 • 1 year
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
2/6 • Number of events 2 • 1 year
|
|
General disorders
Generalized edema
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/6 • 1 year
|
|
General disorders
Injection site reaction
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
General disorders
Pain
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
16.7%
1/6 • Number of events 2 • 1 year
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 2 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
2/6 • Number of events 2 • 1 year
|
|
Infections and infestations
Sepsis
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
33.3%
2/6 • Number of events 2 • 1 year
|
|
Infections and infestations
Viremia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Investigations
Creatinine increased
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Investigations
INR increased
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
100.0%
1/1 • Number of events 4 • 1 year
|
100.0%
1/1 • Number of events 4 • 1 year
|
100.0%
1/1 • Number of events 4 • 1 year
|
16.7%
1/6 • Number of events 2 • 1 year
|
|
Investigations
Neutrophil count decreased
|
100.0%
1/1 • Number of events 5 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
2/6 • Number of events 2 • 1 year
|
|
Investigations
Platelet count decreased
|
100.0%
1/1 • Number of events 10 • 1 year
|
100.0%
1/1 • Number of events 3 • 1 year
|
0.00%
0/1 • 1 year
|
50.0%
3/6 • Number of events 5 • 1 year
|
|
Investigations
White blood cell decreased
|
100.0%
1/1 • Number of events 8 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 4 • 1 year
|
33.3%
2/6 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
1/1 • Number of events 1 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/1 • 1 year
|
33.3%
2/6 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
1/1 • Number of events 3 • 1 year
|
100.0%
1/1 • Number of events 4 • 1 year
|
100.0%
1/1 • Number of events 2 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
100.0%
1/1 • Number of events 5 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
33.3%
2/6 • Number of events 3 • 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
100.0%
1/1 • Number of events 3 • 1 year
|
100.0%
1/1 • Number of events 2 • 1 year
|
100.0%
1/1 • Number of events 4 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
100.0%
1/1 • Number of events 2 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Nervous system disorders
Encephalopathy
|
100.0%
1/1 • Number of events 2 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
33.3%
2/6 • Number of events 2 • 1 year
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
50.0%
3/6 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
16.7%
1/6 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Vascular disorders
Arterial thromboembolism
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
100.0%
1/1 • Number of events 1 • 1 year
|
33.3%
2/6 • Number of events 2 • 1 year
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
16.7%
1/6 • Number of events 2 • 1 year
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
0.00%
0/1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
Additional Information
Dr. Joseph Maakaron
University of Minnesota, Masonic Cancer Center
Phone: 612-624-5109
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place