Trial Outcomes & Findings for A Phase I/II Study to Evaluate the Safety of Cellular Immunotherapy Using Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor for Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas (NCT NCT03277729)
NCT ID: NCT03277729
Last Updated: 2026-01-05
Results Overview
Will be graded by Common Terminology Criteria for Adverse Events version 4.0. Observed DLT rates will be summarized based on the DLT-Evaluable analysis set. Outcome reported as count of participants in each arm who experienced a DLT.
ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
53 participants
Up to 28 days
2026-01-05
Participant Flow
Fifty-three participants were enrolled but three participants did not move on to treatment due to worsening of their disease status. They were not assigned to a treatment dose level.
Participant milestones
| Measure |
Dose Level 0 of CD20 CAR T Cells
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.
Arm 1 contains patients treated at Dose Level 0 (1 x 10\^5 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 8.51 x 10\^4 - 2.80 x 10\^5 tCD19+ T cells/kg)
Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV
Leukapheresis: Undergo leukapheresis
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
|
Dose Level 1 of CD20 CAR T Cells
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.
Arm 2 contains patients treated at Dose Level 1 (3.3 x 10\^5 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 2.81 x 10\^5 - 8.50 x 10\^5 tCD19+ T cells/kg)
Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV
Leukapheresis: Undergo leukapheresis
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
|
Dose Level 2 of CD20 CAR T Cells
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.
Arm 3 contains patients treated at Dose Level 2 (1 x 10\^6 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 8.51 x 10\^5 - 2.80 x 10\^6 tCD19+ T cells/kg)
Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV
Leukapheresis: Undergo leukapheresis
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
|
Dose Level 3 of CD20 CAR-T Cells
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.
Arm 4 contains patients treated at Dose Level 3 (3.3 x 10\^6 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 2.81 x 10\^6 - 8.50 x 10\^6 tCD19+ T cells/kg)
Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV
Leukapheresis: Undergo leukapheresis
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
|
Dose Level 4 of CD20 CAR-T Cells
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.
Arm 5 contains patients treated at Dose Level 4 (1 x 10\^7 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: \> 8.5 x 10\^6 tCD19+ T cells/kg)
Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV
Leukapheresis: Undergo leukapheresis
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
8
|
4
|
6
|
31
|
|
Overall Study
COMPLETED
|
1
|
1
|
0
|
5
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
7
|
4
|
1
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase I/II Study to Evaluate the Safety of Cellular Immunotherapy Using Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor for Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas
Baseline characteristics by cohort
| Measure |
Dose Level 0 of CD20 CAR T Cells
n=1 Participants
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.
Arm 1 contains patients treated at Dose Level 0 (1 x 10\^5 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 8.51 x 10\^4 - 2.80 x 10\^5 tCD19+ T cells/kg)
Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV
Leukapheresis: Undergo leukapheresis
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
|
Dose Level 1 of CD20 CAR T Cells
n=8 Participants
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.
Arm 2 contains patients treated at Dose Level 1 (3.3 x 10\^5 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 2.81 x 10\^5 - 8.50 x 10\^5 tCD19+ T cells/kg)
Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV
Leukapheresis: Undergo leukapheresis
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
|
Dose Level 2 of CD20 CAR T Cells
n=4 Participants
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.
Arm 3 contains patients treated at Dose Level 2 (1 x 10\^6 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 8.51 x 10\^5 - 2.80 x 10\^6 tCD19+ T cells/kg)
Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV
Leukapheresis: Undergo leukapheresis
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
|
Dose Level 3 of CD20 CAR-T Cells
n=6 Participants
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.
Arm 4 contains patients treated at Dose Level 3 (3.3 x 10\^6 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 2.81 x 10\^6 - 8.50 x 10\^6 tCD19+ T cells/kg)
Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV
Leukapheresis: Undergo leukapheresis
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
|
Dose Level 4 of CD20 CAR-T Cells
n=31 Participants
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.
Arm 5 contains patients treated at Dose Level 4 (1 x 10\^7 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: \> 8.5 x 10\^6 tCD19+ T cells/kg)
Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV
Leukapheresis: Undergo leukapheresis
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Sex: Female, Male
Male
|
0 Participants
n=9667 Participants
|
6 Participants
n=6597 Participants
|
3 Participants
n=16264 Participants
|
4 Participants
n=31 Participants
|
18 Participants
n=21 Participants
|
31 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9667 Participants
|
1 Participants
n=6597 Participants
|
0 Participants
n=16264 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9667 Participants
|
0 Participants
n=6597 Participants
|
0 Participants
n=16264 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=9667 Participants
|
7 Participants
n=6597 Participants
|
4 Participants
n=16264 Participants
|
6 Participants
n=31 Participants
|
28 Participants
n=21 Participants
|
46 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=9667 Participants
|
8 participants
n=6597 Participants
|
4 participants
n=16264 Participants
|
6 participants
n=31 Participants
|
31 participants
n=21 Participants
|
50 participants
n=3 Participants
|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 0 • n=9667 Participants
|
61 years
STANDARD_DEVIATION 9 • n=6597 Participants
|
61 years
STANDARD_DEVIATION 8 • n=16264 Participants
|
59 years
STANDARD_DEVIATION 9 • n=31 Participants
|
67 years
STANDARD_DEVIATION 8 • n=21 Participants
|
64 years
STANDARD_DEVIATION 9 • n=3 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=9667 Participants
|
2 Participants
n=6597 Participants
|
1 Participants
n=16264 Participants
|
2 Participants
n=31 Participants
|
13 Participants
n=21 Participants
|
19 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysWill be graded by Common Terminology Criteria for Adverse Events version 4.0. Observed DLT rates will be summarized based on the DLT-Evaluable analysis set. Outcome reported as count of participants in each arm who experienced a DLT.
Outcome measures
| Measure |
Dose Level 0 of CD20 CAR T Cells
n=1 Participants
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.
Arm 1 contains patients treated at Dose Level 0 (1 x 10\^5 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 8.51 x 10\^4 - 2.80 x 10\^5 tCD19+ T cells/kg)
Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV
Leukapheresis: Undergo leukapheresis
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
|
Dose Level 1 of CD20 CAR T Cells
n=8 Participants
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.
Arm 2 contains patients treated at Dose Level 1 (3.3 x 10\^5 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 2.81 x 10\^5 - 8.50 x 10\^5 tCD19+ T cells/kg)
Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV
Leukapheresis: Undergo leukapheresis
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
|
Dose Level 2 of CD20 CAR T Cells
n=4 Participants
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.
Arm 3 contains patients treated at Dose Level 2 (1 x 10\^6 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 8.51 x 10\^5 - 2.80 x 10\^6 tCD19+ T cells/kg)
Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV
Leukapheresis: Undergo leukapheresis
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
|
Dose Level 3 of CD20 CAR-T Cells
n=6 Participants
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.
Arm 4 contains patients treated at Dose Level 3 (3.3 x 10\^6 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 2.81 x 10\^6 - 8.50 x 10\^6 tCD19+ T cells/kg)
Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV
Leukapheresis: Undergo leukapheresis
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
|
Dose Level 4 of CD20 CAR-T Cells
n=31 Participants
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.
Arm 5 contains patients treated at Dose Level 4 (1 x 10\^7 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: \> 8.5 x 10\^6 tCD19+ T cells/kg)
Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV
Leukapheresis: Undergo leukapheresis
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
|
|---|---|---|---|---|---|
|
Dose-limiting Toxicities (DLT) Rate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 15 yearsWill be assessed based on the Lugano criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Duration from study enrollment to progression or death due to any cause (whichever comes first), assessed up to 15 yearsA Cox proportional hazards model will be used to evaluate PFS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Duration from study enrollment to death due to any cause, assessed up to 15 yearsA Cox proportional hazards model will be used to evaluate OS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 15 yearsWill be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Outcome measures
Outcome data not reported
Adverse Events
Dose Level 0 of CD20 CAR T Cells
Dose Level 1 of CD20 CAR T Cells
Dose Level 2 of CD20 CAR T Cells
Dose Level 3 of CD20 CAR-T Cells
Dose Level 4 of CD20 CAR-T Cells
Serious adverse events
| Measure |
Dose Level 0 of CD20 CAR T Cells
n=1 participants at risk
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.
Arm 1 contains patients treated at Dose Level 0 (1 x 10\^5 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 8.51 x 10\^4 - 2.80 x 10\^5 tCD19+ T cells/kg)
Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV
Leukapheresis: Undergo leukapheresis
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
|
Dose Level 1 of CD20 CAR T Cells
n=8 participants at risk
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.
Arm 2 contains patients treated at Dose Level 1 (3.3 x 10\^5 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 2.81 x 10\^5 - 8.50 x 10\^5 tCD19+ T cells/kg)
Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV
Leukapheresis: Undergo leukapheresis
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
|
Dose Level 2 of CD20 CAR T Cells
n=4 participants at risk
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.
Arm 3 contains patients treated at Dose Level 2 (1 x 10\^6 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 8.51 x 10\^5 - 2.80 x 10\^6 tCD19+ T cells/kg)
Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV
Leukapheresis: Undergo leukapheresis
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
|
Dose Level 3 of CD20 CAR-T Cells
n=6 participants at risk
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.
Arm 4 contains patients treated at Dose Level 3 (3.3 x 10\^6 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 2.81 x 10\^6 - 8.50 x 10\^6 tCD19+ T cells/kg)
Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV
Leukapheresis: Undergo leukapheresis
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
|
Dose Level 4 of CD20 CAR-T Cells
n=31 participants at risk
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.
Arm 5 contains patients treated at Dose Level 4 (1 x 10\^7 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: \> 8.5 x 10\^6 tCD19+ T cells/kg)
Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV
Leukapheresis: Undergo leukapheresis
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
|
|---|---|---|---|---|---|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
33.3%
2/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
38.7%
12/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
100.0%
1/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.0%
1/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
9.7%
3/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
General disorders
Fever
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
16.1%
5/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Infections and infestations
Lung infection
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
6.5%
2/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Immune system disorders
Immune system disorders
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
6.5%
2/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
General disorders
General disorders and administration site conditions - Other, COVID
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
16.7%
1/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukemia secondary to oncology chemotherapy
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
General disorders
Pain
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.0%
1/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
16.7%
1/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Infections and infestations
Rash
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Infections and infestations
Skin infection
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Nervous system disorders
Spasticity
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
Other adverse events
| Measure |
Dose Level 0 of CD20 CAR T Cells
n=1 participants at risk
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.
Arm 1 contains patients treated at Dose Level 0 (1 x 10\^5 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 8.51 x 10\^4 - 2.80 x 10\^5 tCD19+ T cells/kg)
Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV
Leukapheresis: Undergo leukapheresis
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
|
Dose Level 1 of CD20 CAR T Cells
n=8 participants at risk
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.
Arm 2 contains patients treated at Dose Level 1 (3.3 x 10\^5 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 2.81 x 10\^5 - 8.50 x 10\^5 tCD19+ T cells/kg)
Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV
Leukapheresis: Undergo leukapheresis
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
|
Dose Level 2 of CD20 CAR T Cells
n=4 participants at risk
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.
Arm 3 contains patients treated at Dose Level 2 (1 x 10\^6 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 8.51 x 10\^5 - 2.80 x 10\^6 tCD19+ T cells/kg)
Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV
Leukapheresis: Undergo leukapheresis
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
|
Dose Level 3 of CD20 CAR-T Cells
n=6 participants at risk
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.
Arm 4 contains patients treated at Dose Level 3 (3.3 x 10\^6 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 2.81 x 10\^6 - 8.50 x 10\^6 tCD19+ T cells/kg)
Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV
Leukapheresis: Undergo leukapheresis
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
|
Dose Level 4 of CD20 CAR-T Cells
n=31 participants at risk
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.
Arm 5 contains patients treated at Dose Level 4 (1 x 10\^7 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: \> 8.5 x 10\^6 tCD19+ T cells/kg)
Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV
Leukapheresis: Undergo leukapheresis
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
|
|---|---|---|---|---|---|
|
Investigations
Lymphocyte count decreased
|
100.0%
1/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
100.0%
8/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
100.0%
4/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
100.0%
6/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
90.3%
28/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Investigations
Neutrophil count decreased
|
100.0%
1/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
87.5%
7/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
100.0%
4/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
83.3%
5/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
93.5%
29/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
General disorders
Fever
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.0%
2/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
50.0%
2/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
33.3%
2/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.8%
8/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Investigations
White blood cell decreased
|
100.0%
1/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
100.0%
8/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
100.0%
4/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
83.3%
5/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
90.3%
28/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
75.0%
6/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
50.0%
2/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
50.0%
3/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
80.6%
25/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
87.5%
7/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
50.0%
2/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
66.7%
4/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
41.9%
13/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
62.5%
5/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
75.0%
3/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
50.0%
3/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
41.9%
13/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
37.5%
3/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
50.0%
2/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
33.3%
2/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
41.9%
13/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Vascular disorders
Hypotension
|
100.0%
1/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
50.0%
4/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
50.0%
2/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
16.7%
1/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
32.3%
10/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
37.5%
3/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
50.0%
2/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
33.3%
2/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
22.6%
7/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
1/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
37.5%
3/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
50.0%
2/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
16.7%
1/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
22.6%
7/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Nervous system disorders
Headache
|
100.0%
1/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.0%
2/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
50.0%
2/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
33.3%
2/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
22.6%
7/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
37.5%
3/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
50.0%
2/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
33.3%
2/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
19.4%
6/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
50.0%
4/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
33.3%
2/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
22.6%
7/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
62.5%
5/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
75.0%
3/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
33.3%
2/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
37.5%
3/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
50.0%
2/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
16.7%
1/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
16.1%
5/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
37.5%
3/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.0%
1/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
66.7%
4/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
9.7%
3/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.0%
2/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.0%
1/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
16.7%
1/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
16.1%
5/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Immune system disorders
Cytokine release syndrome
|
100.0%
1/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
19.4%
6/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.0%
2/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
33.3%
2/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.9%
4/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Investigations
Creatinine increased
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
50.0%
2/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
16.7%
1/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
9.7%
3/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
General disorders
Pain
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
50.0%
2/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
9.7%
3/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
50.0%
2/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
16.7%
1/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
6.5%
2/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
General disorders
Edema limbs
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
50.0%
2/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
16.7%
1/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
6.5%
2/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.0%
1/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
33.3%
2/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
9.7%
3/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
50.0%
2/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
16.7%
1/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
General disorders
Chills
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.0%
2/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.0%
1/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
16.7%
1/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.0%
1/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
33.3%
2/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
6.5%
2/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Metabolism and nutrition disorders
Hypomagnesimia
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.0%
1/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
9.7%
3/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.0%
2/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
50.0%
2/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.0%
2/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.0%
1/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
16.7%
1/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.0%
2/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
16.7%
1/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
50.0%
2/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
6.5%
2/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Injury, poisoning and procedural complications
Activated partial thromboplastin time prolonged
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.0%
2/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.0%
1/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
9.7%
3/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
6.5%
2/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
16.7%
1/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
6.5%
2/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
9.7%
3/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Infections and infestations
Lung infection
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
6.5%
2/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.0%
1/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
6.5%
2/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.0%
1/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.0%
1/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.0%
1/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
6.5%
2/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
6.5%
2/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.0%
1/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Eye disorders
Blurred vision
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Gastrointestinal disorders
Abdominal distention
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
16.7%
1/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
General disorders
General disorders and administration site conditions - Other, Altered Handwriting
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
General disorders
General disorders and administration site conditions - Other, Bilateral Feet Pain
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
16.7%
1/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.0%
1/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Immune system disorders
Immune system disorders - Other, CMV Viremia Reactivation
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Nervous system disorders
Cognitive disorders
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Infections and infestations
Infections and infestations - Other, CoNS Bacteremia
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
16.7%
1/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
General disorders
Edema face
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
General disorders
Edema trunk
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.0%
1/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Gastrointestinal disorders
Enterocolitis infection
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.0%
1/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
16.7%
1/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
General disorders
Gait disturbance
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
16.7%
1/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Infections and infestations
Infections and infestations - Other, GPR Bacteremia
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
General disorders
General disorders and administration site conditions - Other, Handwriting change
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Metabolism and nutrition disorders
Hyperalbuminemia
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
General disorders
Hypothermia
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
General disorders
Irritability
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, Muscle cramp
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.0%
1/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, Nocturia
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, Numbness
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Rash
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
16.7%
1/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
16.7%
1/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
25.0%
1/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Nervous system disorders
Tremor
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
12.5%
1/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
3.2%
1/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, Worsening of knee pain]
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
16.7%
1/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Worsening of night sweats
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
16.7%
1/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
|
General disorders
General dis...General disorders and administration site conditions - Other, COVID
|
0.00%
0/1 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/8 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/4 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
0.00%
0/6 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
6.5%
2/31 • Adverse Events and All-Cause Mortality were assessed up to 1 year after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 1 year after first and only CAR T infusion for all patients.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place