NCT03602612 · ADVERSE EVENTS

Adverse events

T Cells Expressing a Novel Fully-Human Anti-BCMA CAR for Treating Multiple Myeloma · Source last updated 2026-06-16

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Date treatment consent signed to date off study, approximately 16 months/17 days, 4 months/4 days, 4 months/18 days, 42 months/8 days, 20 months/19 days, 29 months/28 days, and 30 months/26 days for each Arm/Group respectively.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm 1 Dose Escalation (Esc) Dose Level 1 - 0.75x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg Participants received 0.75x10\^6 Chimeric Antigen Receptor (CAR)+ T cells per kg infused on day 0 + Cyclophosphamide: 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 + Fludarabine: 30 mg /m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3.	6 / 6	6 / 6	1 / 6
Arm 1 Dose Escalation Dose Level 2 - 1.5x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg Participants received 1.5x10\^6 Chimeric Antigen Receptor (CAR)+ T cells per kg infused on day 0 + Cyclophosphamide: 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 + Fludarabine: 30 mg /m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3.	1 / 3	3 / 3	0 / 3
Arm 1 Dose Escalation Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg Participants received 3.0x10\^6 Chimeric Antigen Receptor (CAR)+ T cells per kg infused on day 0 + Cyclophosphamide: 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 + Fludarabine: 30 mg /m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3.	2 / 2	2 / 2	0 / 2
Arm 1 Dose Escalation Dose Level 4 - 6.0x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg Participants received 6.0x10\^6 Chimeric Antigen Receptor (CAR)+ T cells per kg infused on day 0 + Cyclophosphamide: 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 + Fludarabine: 30 mg /m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3.	2 / 3	3 / 3	0 / 3
Arm 1 Dose Escalation Dose Level 5 - 12.0x1^06 Chimeric Antigen Receptor (CAR)+ T Cells Per kg Participants received 12.0x1\^06 Chimeric Antigen Receptor (CAR)+ T cells per kg infused on day 0 + Cyclophosphamide: 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 + Fludarabine: 30 mg /m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3.	3 / 3	3 / 3	0 / 3
Arm 2 Dose Expansion (Exp) 6.0x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg Participants received 6.0x10\^6 (maximum feasible dose) CAR+T cells per kg + Cyclophosphamide: 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 + Fludarabine: 30 mg/m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3	6 / 8	8 / 8	0 / 8
Arm 1 DoseEsc DL 3-3.0x10^6 CAR+T Cells Per kg Followed by Arm 2 DoseExp 6.0x10^6 CAR+T Cells Per kg Dose Escalation: Participants received 3.0x10\^6 CAR+T cells per kg infused on day 0 + Cyclophosphamide: 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 + Fludarabine: 30 mg /m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3 AND Dose Expansion: Participants received 6.0x10\^6 (maximum feasible dose) CAR+T cells per kg + Cyclophosphamide: 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 + Fludarabine: 30 mg/m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3	1 / 1	1 / 1	0 / 1

Group identifiers: EG000: Arm 1 Dose Escalation (Esc) Dose Level 1 - 0.75x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg · EG001: Arm 1 Dose Escalation Dose Level 2 - 1.5x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg · EG002: Arm 1 Dose Escalation Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg · EG003: Arm 1 Dose Escalation Dose Level 4 - 6.0x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg · EG004: Arm 1 Dose Escalation Dose Level 5 - 12.0x1^06 Chimeric Antigen Receptor (CAR)+ T Cells Per kg · EG005: Arm 2 Dose Expansion (Exp) 6.0x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg · EG006: Arm 1 DoseEsc DL 3-3.0x10^6 CAR+T Cells Per kg Followed by Arm 2 DoseExp 6.0x10^6 CAR+T Cells Per kg

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
8
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
2
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
8
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
8
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
8
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
CPK increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
8
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Cognitive disturbance
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
0
num At Risk
8
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Confusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
2
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
8
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
4
num At Risk
8
num Events
5
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Cytokine release syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
2
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
8
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
8
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Dysarthria
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
2
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
8
num Events
0
group Id
EG006
num Affected
1
num At Risk
1
num Events
1
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
8
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Ejection fraction decreased

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
8
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Abdominal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
1
num At Risk
8
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
8
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
2
num Events
2
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
2
num At Risk
3
num Events
2
group Id
EG005
num Affected
0
num At Risk
8
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
2
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
1
num At Risk
8
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
6
num At Risk
6
num Events
47
group Id
EG001
num Affected
3
num At Risk
3
num Events
12
group Id
EG002
num Affected
2
num At Risk
2
num Events
11
group Id
EG003
num Affected
2
num At Risk
3
num Events
15
group Id
EG004
num Affected
3
num At Risk
3
num Events
22
group Id
EG005
num Affected
8
num At Risk
8
num Events
48
group Id
EG006
num Affected
1
num At Risk
1
num Events
3
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
4
num At Risk
6
num Events
7
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
2
num At Risk
8
num Events
3
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
0
num At Risk
8
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
5
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
2
num Events
3
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
2
num At Risk
8
num Events
2
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
2
num At Risk
8
num Events
5
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
2
num Events
1
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
1
num At Risk
8
num Events
2
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
8
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Bone pain

Complete source fields

event Groups

deaths Num Affected
1
deaths Num At Risk
6
description
Participants received 0.75x10\^6 Chimeric Antigen Receptor (CAR)+ T cells per kg infused on day 0 + Cyclophosphamide: 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 + Fludarabine: 30 mg /m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3.
id
EG000
other Num Affected
6
other Num At Risk
6
serious Num Affected
6
serious Num At Risk
6
title
Arm 1 Dose Escalation (Esc) Dose Level 1 - 0.75x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg
deaths Num Affected
0
deaths Num At Risk
3
description
Participants received 1.5x10\^6 Chimeric Antigen Receptor (CAR)+ T cells per kg infused on day 0 + Cyclophosphamide: 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 + Fludarabine: 30 mg /m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3.
id
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Arm 1 Dose Escalation Dose Level 2 - 1.5x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg
deaths Num Affected
0
deaths Num At Risk
2
description
Participants received 3.0x10\^6 Chimeric Antigen Receptor (CAR)+ T cells per kg infused on day 0 + Cyclophosphamide: 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 + Fludarabine: 30 mg /m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3.
id
EG002
other Num Affected
2
other Num At Risk
2
serious Num Affected
2
serious Num At Risk
2
title
Arm 1 Dose Escalation Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg
deaths Num Affected
0
deaths Num At Risk
3
description
Participants received 6.0x10\^6 Chimeric Antigen Receptor (CAR)+ T cells per kg infused on day 0 + Cyclophosphamide: 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 + Fludarabine: 30 mg /m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3.
id
EG003
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Arm 1 Dose Escalation Dose Level 4 - 6.0x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg
deaths Num Affected
0
deaths Num At Risk
3
description
Participants received 12.0x1\^06 Chimeric Antigen Receptor (CAR)+ T cells per kg infused on day 0 + Cyclophosphamide: 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 + Fludarabine: 30 mg /m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3.
id
EG004
other Num Affected
3
other Num At Risk
3
serious Num Affected
3
serious Num At Risk
3
title
Arm 1 Dose Escalation Dose Level 5 - 12.0x1^06 Chimeric Antigen Receptor (CAR)+ T Cells Per kg
deaths Num Affected
0
deaths Num At Risk
8
description
Participants received 6.0x10\^6 (maximum feasible dose) CAR+T cells per kg + Cyclophosphamide: 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 + Fludarabine: 30 mg/m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3
id
EG005
other Num Affected
8
other Num At Risk
8
serious Num Affected
6
serious Num At Risk
8
title
Arm 2 Dose Expansion (Exp) 6.0x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg
deaths Num Affected
0
deaths Num At Risk
1
description
Dose Escalation: Participants received 3.0x10\^6 CAR+T cells per kg infused on day 0 + Cyclophosphamide: 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 + Fludarabine: 30 mg /m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3 AND Dose Expansion: Participants received 6.0x10\^6 (maximum feasible dose) CAR+T cells per kg + Cyclophosphamide: 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 + Fludarabine: 30 mg/m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3
id
EG006
other Num Affected
1
other Num At Risk
1
serious Num Affected
1
serious Num At Risk
1
title
Arm 1 DoseEsc DL 3-3.0x10^6 CAR+T Cells Per kg Followed by Arm 2 DoseExp 6.0x10^6 CAR+T Cells Per kg

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
8
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Abdominal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
1
num At Risk
8
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
8
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
2
num Events
2
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
2
num At Risk
3
num Events
2
group Id
EG005
num Affected
0
num At Risk
8
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
2
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
1
num At Risk
8
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
6
num At Risk
6
num Events
47
group Id
EG001
num Affected
3
num At Risk
3
num Events
12
group Id
EG002
num Affected
2
num At Risk
2
num Events
11
group Id
EG003
num Affected
2
num At Risk
3
num Events
15
group Id
EG004
num Affected
3
num At Risk
3
num Events
22
group Id
EG005
num Affected
8
num At Risk
8
num Events
48
group Id
EG006
num Affected
1
num At Risk
1
num Events
3
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
4
num At Risk
6
num Events
7
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
2
num At Risk
8
num Events
3
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
0
num At Risk
8
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
5
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
2
num Events
3
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
2
num At Risk
8
num Events
2
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
2
num At Risk
8
num Events
5
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
2
num Events
1
group Id
EG003
num Affected
1
num At Risk
3
num Events
1
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
1
num At Risk
8
num Events
2
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
8
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Bone pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
8
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
1
num At Risk
3
num Events
2
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
1
num At Risk
8
num Events
1
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
8
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
8
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
CPK increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
8
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Cognitive disturbance
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
3
num Events
1
group Id
EG005
num Affected
0
num At Risk
8
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Confusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
2
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
8
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
4
num At Risk
8
num Events
5
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Cytokine release syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
2
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
8
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
8
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Dysarthria
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
2
num Events
1
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
8
num Events
0
group Id
EG006
num Affected
1
num At Risk
1
num Events
1
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
2
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
3
num Events
0
group Id
EG005
num Affected
0
num At Risk
8
num Events
0
group Id
EG006
num Affected
0
num At Risk
1
num Events
0
term
Ejection fraction decreased

time Frame

Date treatment consent signed to date off study, approximately 16 months/17 days, 4 months/4 days, 4 months/18 days, 42 months/8 days, 20 months/19 days, 29 months/28 days, and 30 months/26 days for each Arm/Group respectively.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice