Trial Outcomes & Findings for Autologous CD22 CAR T Cells in Adults w/ Recurrent or Refractory B Cell Malignancies (NCT NCT04088890)
NCT ID: NCT04088890
Last Updated: 2026-03-30
Results Overview
Incidence and severity of dose limiting toxicities (DLTs) following chemotherapy preparative regimen and infusion of CD22 CAR T cells, as recorded and graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, at each dose level tested in subjects with aggressive B-cell NHL
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
52 participants
Primary outcome timeframe
28 days after infusion
Results posted on
2026-03-30
Participant Flow
Participant milestones
| Measure |
R/R Aggressive B-cell NHL - Dose Level 1 (1×10⁶ Cells/kg)
Participants with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) received lymphodepleting chemotherapy (fludarabine 30 mg/m²/day and cyclophosphamide 500 mg/m²/day for 3 days) followed by infusion of autologous CD22 CAR T cells at Dose Level 1 (1×10⁶ cells/kg ± 20%).
|
R/R Aggressive B-cell NHL - Dose Level 2 (3×10⁶ Cells/kg)
Participants with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) received lymphodepleting chemotherapy (fludarabine 30 mg/m²/day and cyclophosphamide 500 mg/m²/day for 3 days) followed by infusion of autologous CD22 CAR T cells at Dose Level 2 (3×10⁶ cells/kg ± 20%).
|
R/R ALL - Dose Level 1 (1×10⁶ Cells/kg)
Participants with relapsed/refractory acute lymphoblastic leukemia (ALL) received autologous CD22 CAR T cells following lymphodepleting chemotherapy (fludarabine 30 mg/m²/day and cyclophosphamide 500 mg/m²/day for 3 days).
CD22 CAR T cells were administered intravenously at Dose Level 1 (1×10⁶ cells/kg ± 20%).
|
|---|---|---|---|
|
Overall Study
STARTED
|
32
|
9
|
10
|
|
Overall Study
Treated (Received CD22 CAR T cells)
|
29
|
9
|
9
|
|
Overall Study
Completed Day +28 Assessment
|
29
|
9
|
9
|
|
Overall Study
Completed 3 Months Follow-up
|
22
|
5
|
5
|
|
Overall Study
Completed 12 Months Follow-up
|
12
|
4
|
3
|
|
Overall Study
Completed 24 Months Follow-up
|
11
|
4
|
2
|
|
Overall Study
COMPLETED
|
11
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
21
|
5
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Autologous CD22 CAR T Cells in Adults w/ Recurrent or Refractory B Cell Malignancies
Baseline characteristics by cohort
| Measure |
R/R Aggressive B-cell NHL - Dose Level 1 (1×10⁶ Cells/kg)
n=32 Participants
Participants with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) received lymphodepleting chemotherapy (fludarabine 30 mg/m²/day and cyclophosphamide 500 mg/m²/day for 3 days) followed by infusion of autologous CD22 CAR T cells at Dose Level 1 (1×10⁶ cells/kg ± 20%).
|
R/R Aggressive B-cell NHL - Dose Level 2 (3×10⁶ Cells/kg)
n=9 Participants
Participants with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) received lymphodepleting chemotherapy (fludarabine 30 mg/m²/day and cyclophosphamide 500 mg/m²/day for 3 days) followed by infusion of autologous CD22 CAR T cells at Dose Level 2 (3×10⁶ cells/kg ± 20%).
|
R/R ALL - Dose Level 1 (1×10⁶ Cells/kg)
n=10 Participants
Participants with relapsed/refractory acute lymphoblastic leukemia (ALL) received autologous CD22 CAR T cells following lymphodepleting chemotherapy (fludarabine 30 mg/m²/day and cyclophosphamide 500 mg/m²/day for 3 days).
CD22 CAR T cells were administered intravenously at Dose Level 1 (1×10⁶ cells/kg ± 20%).
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
70-79 years old
|
10 Participants
n=4 Participants
|
4 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
14 Participants
n=38 Participants
|
|
Age, Customized
18-29 years old
|
1 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=38 Participants
|
|
Age, Customized
30-39 years old
|
2 Participants
n=4 Participants
|
1 Participants
n=28 Participants
|
3 Participants
n=10 Participants
|
6 Participants
n=38 Participants
|
|
Age, Customized
40-49 years old
|
2 Participants
n=4 Participants
|
1 Participants
n=28 Participants
|
4 Participants
n=10 Participants
|
7 Participants
n=38 Participants
|
|
Age, Customized
50-59 years old
|
7 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
7 Participants
n=38 Participants
|
|
Age, Customized
60-69 years old
|
9 Participants
n=4 Participants
|
3 Participants
n=28 Participants
|
1 Participants
n=10 Participants
|
13 Participants
n=38 Participants
|
|
Age, Customized
80-89 years old
|
1 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=38 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=4 Participants
|
2 Participants
n=28 Participants
|
3 Participants
n=10 Participants
|
20 Participants
n=38 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=4 Participants
|
7 Participants
n=28 Participants
|
7 Participants
n=10 Participants
|
31 Participants
n=38 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
6 Participants
n=10 Participants
|
12 Participants
n=38 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=4 Participants
|
9 Participants
n=28 Participants
|
4 Participants
n=10 Participants
|
39 Participants
n=38 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=38 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=38 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=4 Participants
|
1 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=38 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=38 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=38 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=4 Participants
|
7 Participants
n=28 Participants
|
4 Participants
n=10 Participants
|
34 Participants
n=38 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=38 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=4 Participants
|
1 Participants
n=28 Participants
|
6 Participants
n=10 Participants
|
12 Participants
n=38 Participants
|
|
Region of Enrollment
United States
|
32 Participants
n=4 Participants
|
9 Participants
n=28 Participants
|
10 Participants
n=10 Participants
|
51 Participants
n=38 Participants
|
PRIMARY outcome
Timeframe: 7-11 days from start of manufacturingThe percentage of apheresis samples (fresh or frozen) that are successfully processed and expanded to manufacture CD22 CAR T cells will be determined for each dose cohort.
Outcome measures
| Measure |
R/R Aggressive B-cell NHL - Dose Level 1 (1×10⁶ Cells/kg)
n=31 Participants
Participants with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) received lymphodepleting chemotherapy (fludarabine 30 mg/m²/day and cyclophosphamide 500 mg/m²/day for 3 days) followed by infusion of autologous CD22 CAR T cells at Dose Level 1 (1×10⁶ cells/kg ± 20%).
|
R/R Aggressive B-cell NHL - Dose Level 2 (3×10⁶ Cells/kg)
n=9 Participants
Participants with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) received lymphodepleting chemotherapy (fludarabine 30 mg/m²/day and cyclophosphamide 500 mg/m²/day for 3 days) followed by infusion of autologous CD22 CAR T cells at Dose Level 2 (3×10⁶ cells/kg ± 20%).
|
R/R ALL - Dose Level 1 (1×10⁶ Cells/kg)
n=9 Participants
Participants with relapsed/refractory acute lymphoblastic leukemia (ALL) received autologous CD22 CAR T cells following lymphodepleting chemotherapy (fludarabine 30 mg/m²/day and cyclophosphamide 500 mg/m²/day for 3 days).
CD22 CAR T cells were administered intravenously at Dose Level 1 (1×10⁶ cells/kg ± 20%).
|
|---|---|---|---|
|
Rate of Successful Manufacture of CD22 CAR T Cells
|
94 Percentage
|
100 Percentage
|
100 Percentage
|
PRIMARY outcome
Timeframe: 28 days after infusionIncidence and severity of dose limiting toxicities (DLTs) following chemotherapy preparative regimen and infusion of CD22 CAR T cells, as recorded and graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, at each dose level tested in subjects with aggressive B-cell NHL
Outcome measures
| Measure |
R/R Aggressive B-cell NHL - Dose Level 1 (1×10⁶ Cells/kg)
n=29 Participants
Participants with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) received lymphodepleting chemotherapy (fludarabine 30 mg/m²/day and cyclophosphamide 500 mg/m²/day for 3 days) followed by infusion of autologous CD22 CAR T cells at Dose Level 1 (1×10⁶ cells/kg ± 20%).
|
R/R Aggressive B-cell NHL - Dose Level 2 (3×10⁶ Cells/kg)
n=9 Participants
Participants with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) received lymphodepleting chemotherapy (fludarabine 30 mg/m²/day and cyclophosphamide 500 mg/m²/day for 3 days) followed by infusion of autologous CD22 CAR T cells at Dose Level 2 (3×10⁶ cells/kg ± 20%).
|
R/R ALL - Dose Level 1 (1×10⁶ Cells/kg)
Participants with relapsed/refractory acute lymphoblastic leukemia (ALL) received autologous CD22 CAR T cells following lymphodepleting chemotherapy (fludarabine 30 mg/m²/day and cyclophosphamide 500 mg/m²/day for 3 days).
CD22 CAR T cells were administered intravenously at Dose Level 1 (1×10⁶ cells/kg ± 20%).
|
|---|---|---|---|
|
Incidence of Dose Limiting Toxicities (DLTs) in Subjects With Aggressive B-cell NHL
Participants with DLTs
|
0 Participants
|
2 Participants
|
—
|
|
Incidence of Dose Limiting Toxicities (DLTs) in Subjects With Aggressive B-cell NHL
Participants without DLTs
|
29 Participants
|
7 Participants
|
—
|
PRIMARY outcome
Timeframe: 28 days after infusionPopulation: Analysis includes participants in the R/R ALL cohort treated at Dose Level 1.
Incidence and severity of dose limiting toxicities (DLTs) following chemotherapy preparative regimen and infusion of CD22 CAR T cells, as recorded and graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, at each dose level tested in subjects with ALL
Outcome measures
| Measure |
R/R Aggressive B-cell NHL - Dose Level 1 (1×10⁶ Cells/kg)
n=7 Participants
Participants with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) received lymphodepleting chemotherapy (fludarabine 30 mg/m²/day and cyclophosphamide 500 mg/m²/day for 3 days) followed by infusion of autologous CD22 CAR T cells at Dose Level 1 (1×10⁶ cells/kg ± 20%).
|
R/R Aggressive B-cell NHL - Dose Level 2 (3×10⁶ Cells/kg)
Participants with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) received lymphodepleting chemotherapy (fludarabine 30 mg/m²/day and cyclophosphamide 500 mg/m²/day for 3 days) followed by infusion of autologous CD22 CAR T cells at Dose Level 2 (3×10⁶ cells/kg ± 20%).
|
R/R ALL - Dose Level 1 (1×10⁶ Cells/kg)
Participants with relapsed/refractory acute lymphoblastic leukemia (ALL) received autologous CD22 CAR T cells following lymphodepleting chemotherapy (fludarabine 30 mg/m²/day and cyclophosphamide 500 mg/m²/day for 3 days).
CD22 CAR T cells were administered intravenously at Dose Level 1 (1×10⁶ cells/kg ± 20%).
|
|---|---|---|---|
|
Safety Evaluation of CD22-CAR T Cells in Subjects With ALL
Participants with DLTs
|
1 Participants
|
—
|
—
|
|
Safety Evaluation of CD22-CAR T Cells in Subjects With ALL
Participants without DLTs
|
6 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after infusionClinical response was assessed at Day 28 per modified International Working Group (IWG) criteria for acute lymphoblastic leukemia. Complete Response (CR) was defined as \<5% bone marrow blasts with hematologic recovery. CR with minimal residual disease (MRD-) required no detectable MRD by protocol-specified assay, whereas CR with MRD+ indicated detectable MRD. Progressive Disease (PD) was defined as increased bone marrow blasts or clinical progression.
Outcome measures
| Measure |
R/R Aggressive B-cell NHL - Dose Level 1 (1×10⁶ Cells/kg)
n=9 Participants
Participants with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) received lymphodepleting chemotherapy (fludarabine 30 mg/m²/day and cyclophosphamide 500 mg/m²/day for 3 days) followed by infusion of autologous CD22 CAR T cells at Dose Level 1 (1×10⁶ cells/kg ± 20%).
|
R/R Aggressive B-cell NHL - Dose Level 2 (3×10⁶ Cells/kg)
Participants with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) received lymphodepleting chemotherapy (fludarabine 30 mg/m²/day and cyclophosphamide 500 mg/m²/day for 3 days) followed by infusion of autologous CD22 CAR T cells at Dose Level 2 (3×10⁶ cells/kg ± 20%).
|
R/R ALL - Dose Level 1 (1×10⁶ Cells/kg)
Participants with relapsed/refractory acute lymphoblastic leukemia (ALL) received autologous CD22 CAR T cells following lymphodepleting chemotherapy (fludarabine 30 mg/m²/day and cyclophosphamide 500 mg/m²/day for 3 days).
CD22 CAR T cells were administered intravenously at Dose Level 1 (1×10⁶ cells/kg ± 20%).
|
|---|---|---|---|
|
Clinical Activity of CD22-CAR T Cells in Adults With Relapsed/Refractory CD22-expressing B-cell ALL at Target Dose
Complete Response (CR, MRD-)
|
5 Participants
|
—
|
—
|
|
Clinical Activity of CD22-CAR T Cells in Adults With Relapsed/Refractory CD22-expressing B-cell ALL at Target Dose
Complete Response (CR, MRD+)
|
2 Participants
|
—
|
—
|
|
Clinical Activity of CD22-CAR T Cells in Adults With Relapsed/Refractory CD22-expressing B-cell ALL at Target Dose
Progressive Disease (PD)
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 months after infusionPopulation: 1 patient died in Complete Response but is excluded from 3 month analysis.
Clinical response was assessed at Month 3 per Lugano 2014 criteria for non-Hodgkin lymphoma. Complete Response (CR) was defined as disappearance of all evidence of disease. Partial Response (PR) was defined as ≥50% reduction in measurable disease. Stable Disease (SD) was defined as neither sufficient shrinkage for PR nor sufficient increase for PD. Progressive Disease (PD) was defined as appearance of new lesions or ≥50% increase in disease burden.
Outcome measures
| Measure |
R/R Aggressive B-cell NHL - Dose Level 1 (1×10⁶ Cells/kg)
n=29 Participants
Participants with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) received lymphodepleting chemotherapy (fludarabine 30 mg/m²/day and cyclophosphamide 500 mg/m²/day for 3 days) followed by infusion of autologous CD22 CAR T cells at Dose Level 1 (1×10⁶ cells/kg ± 20%).
|
R/R Aggressive B-cell NHL - Dose Level 2 (3×10⁶ Cells/kg)
n=8 Participants
Participants with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) received lymphodepleting chemotherapy (fludarabine 30 mg/m²/day and cyclophosphamide 500 mg/m²/day for 3 days) followed by infusion of autologous CD22 CAR T cells at Dose Level 2 (3×10⁶ cells/kg ± 20%).
|
R/R ALL - Dose Level 1 (1×10⁶ Cells/kg)
Participants with relapsed/refractory acute lymphoblastic leukemia (ALL) received autologous CD22 CAR T cells following lymphodepleting chemotherapy (fludarabine 30 mg/m²/day and cyclophosphamide 500 mg/m²/day for 3 days).
CD22 CAR T cells were administered intravenously at Dose Level 1 (1×10⁶ cells/kg ± 20%).
|
|---|---|---|---|
|
Clinical Activity of CD22-CAR T Cells in Adults With Relapsed/Refractory Aggressive B-cell NHL at MTD/RP2D
Complete Response (CR)
|
14 Participants
|
4 Participants
|
—
|
|
Clinical Activity of CD22-CAR T Cells in Adults With Relapsed/Refractory Aggressive B-cell NHL at MTD/RP2D
Partial Response (PR)
|
0 Participants
|
0 Participants
|
—
|
|
Clinical Activity of CD22-CAR T Cells in Adults With Relapsed/Refractory Aggressive B-cell NHL at MTD/RP2D
Stable Disease (SD)
|
0 Participants
|
0 Participants
|
—
|
|
Clinical Activity of CD22-CAR T Cells in Adults With Relapsed/Refractory Aggressive B-cell NHL at MTD/RP2D
Progressive Disease (PD)
|
15 Participants
|
4 Participants
|
—
|
Adverse Events
R/R Aggressive B-cell NHL - Dose Level 2 (3×10⁶ Cells/kg)
Serious events: 9 serious events
Other events: 9 other events
Deaths: 6 deaths
R/R ALL - Dose Level 1 (1×10⁶ Cells/kg)
Serious events: 9 serious events
Other events: 9 other events
Deaths: 6 deaths
R/R Aggressive B-cell NHL - Dose Level 1 (1×10⁶ Cells/kg)
Serious events: 29 serious events
Other events: 29 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
R/R Aggressive B-cell NHL - Dose Level 2 (3×10⁶ Cells/kg)
n=9 participants at risk
Participants with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) received lymphodepleting chemotherapy (fludarabine 30 mg/m²/day and cyclophosphamide 500 mg/m²/day for 3 days) followed by infusion of autologous CD22 CAR T cells at Dose Level 2 (3×10⁶ cells/kg ± 20%).
|
R/R ALL - Dose Level 1 (1×10⁶ Cells/kg)
n=9 participants at risk
Participants with relapsed/refractory acute lymphoblastic leukemia (ALL) received autologous CD22 CAR T cells following lymphodepleting chemotherapy (fludarabine 30 mg/m²/day and cyclophosphamide 500 mg/m²/day for 3 days).
CD22 CAR T cells were administered intravenously at Dose Level 1 (1×10⁶ cells/kg ± 20%).
|
R/R Aggressive B-cell NHL - Dose Level 1 (1×10⁶ Cells/kg)
n=29 participants at risk
Participants with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) received lymphodepleting chemotherapy (fludarabine 30 mg/m²/day and cyclophosphamide 500 mg/m²/day for 3 days) followed by infusion of autologous CD22 CAR T cells at Dose Level 1 (1×10⁶ cells/kg ± 20%).
|
|---|---|---|---|
|
Nervous system disorders
Parathesia
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
General disorders
Fever
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Cardiac disorders
Heart failure
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
Gastrointestinal disorders
Jejunal and ileal obstruction
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
General disorders
Multi-organ failure
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Immune system disorders
Cytokine Release Syndrome
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Immune system disorders
Macrophage activation syndrome
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
Immune system disorders
Other: IEC-HS
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Infections and infestations
Sepsis
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Infections and infestations
Bacteremia
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Infections and infestations
Lung infection
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
Investigations
ANC decreased
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Investigations
Ejection fraction decreased
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Investigations
AST increased
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Investigations
Neutrophils decreased
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other: Treatment-related secondary malignancy (myeloid neoplasm)
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Renal and urinary disorders
Urinary tract infection
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Renal and urinary disorders
Acute kidney injury
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Vascular disorders
Hypotension
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Immune system disorders
Other, IEC-HS
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Nervous system disorders
Other, Cytokine related encephalopathy syndrome (CRES)
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other: Myelodysplastic syndrome (MDS)
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
Other adverse events
| Measure |
R/R Aggressive B-cell NHL - Dose Level 2 (3×10⁶ Cells/kg)
n=9 participants at risk
Participants with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) received lymphodepleting chemotherapy (fludarabine 30 mg/m²/day and cyclophosphamide 500 mg/m²/day for 3 days) followed by infusion of autologous CD22 CAR T cells at Dose Level 2 (3×10⁶ cells/kg ± 20%).
|
R/R ALL - Dose Level 1 (1×10⁶ Cells/kg)
n=9 participants at risk
Participants with relapsed/refractory acute lymphoblastic leukemia (ALL) received autologous CD22 CAR T cells following lymphodepleting chemotherapy (fludarabine 30 mg/m²/day and cyclophosphamide 500 mg/m²/day for 3 days).
CD22 CAR T cells were administered intravenously at Dose Level 1 (1×10⁶ cells/kg ± 20%).
|
R/R Aggressive B-cell NHL - Dose Level 1 (1×10⁶ Cells/kg)
n=29 participants at risk
Participants with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) received lymphodepleting chemotherapy (fludarabine 30 mg/m²/day and cyclophosphamide 500 mg/m²/day for 3 days) followed by infusion of autologous CD22 CAR T cells at Dose Level 1 (1×10⁶ cells/kg ± 20%).
|
|---|---|---|---|
|
General disorders
Edema face
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
General disorders
Fatigue
|
77.8%
7/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
34.5%
10/29 • 2 years post-infusion
|
|
General disorders
Fever
|
88.9%
8/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
96.6%
28/29 • 2 years post-infusion
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/9 • 2 years post-infusion
|
66.7%
6/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
22.2%
2/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/9 • 2 years post-infusion
|
22.2%
2/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
17.2%
5/29 • 2 years post-infusion
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
General disorders
Chills
|
0.00%
0/9 • 2 years post-infusion
|
33.3%
3/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
General disorders
Edema limbs
|
22.2%
2/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
General disorders
Flu like symptoms
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
General disorders
Generalized edema
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
General disorders
Multiorgan failure
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
General disorders
Non-cardiac chest pain
|
22.2%
2/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/9 • 2 years post-infusion
|
77.8%
7/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Immune system disorders
Other: Macrophage Activation Syndrome
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Infections and infestations
Bacteremia
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Infections and infestations
Bone infection
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
Infections and infestations
Cytomegalovirus infection Reactivation
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
Infections and infestations
Lip infection
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Infections and infestations
Lung infection
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Infections and infestations
Otitis media
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
Infections and infestations
Sepsis
|
0.00%
0/9 • 2 years post-infusion
|
22.2%
2/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Infections and infestations
Shingles
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
Infections and infestations
Skin infection
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Infections and infestations
Thrush
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
6.9%
2/29 • 2 years post-infusion
|
|
Injury, poisoning and procedural complications
Bruising
|
22.2%
2/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Investigations
Alkaline phosphatase Increased
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Investigations
Aspartate aminotransferase Increased
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Investigations
Cardiac troponin increased
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Investigations
Fibrinogen decreased
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
10.3%
3/29 • 2 years post-infusion
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/9 • 2 years post-infusion
|
77.8%
7/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Investigations
Platelet count decreased
|
0.00%
0/9 • 2 years post-infusion
|
77.8%
7/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Investigations
Weight loss
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
6.9%
2/29 • 2 years post-infusion
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
10.3%
3/29 • 2 years post-infusion
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm benign (cyst)
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy (myeloid neoplastic processes)
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
6.9%
2/29 • 2 years post-infusion
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
27.6%
8/29 • 2 years post-infusion
|
|
Nervous system disorders
Intracranial hemorrhage
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Nervous system disorders
Presyncope
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Nervous system disorders
Seizures
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Nervous system disorders
Tremor
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
Nervous system disorders
Other: Immune effector cell associated neurotoxicity (ICANS)
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Psychiatric disorders
Confusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
Psychiatric disorders
Delirium
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/9 • 2 years post-infusion
|
22.2%
2/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
6.9%
2/29 • 2 years post-infusion
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
Vascular disorders
Capillary leak syndrome
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Vascular disorders
Hematoma
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
Vascular disorders
Hypertension
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Vascular disorders
Hypotension
|
0.00%
0/9 • 2 years post-infusion
|
33.3%
3/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/9 • 2 years post-infusion
|
0.00%
0/9 • 2 years post-infusion
|
3.4%
1/29 • 2 years post-infusion
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Gastrointestinal disorders
Gum sensitivity
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Infections and infestations
Viremia
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/9 • 2 years post-infusion
|
11.1%
1/9 • 2 years post-infusion
|
0.00%
0/29 • 2 years post-infusion
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place