Trial Outcomes & Findings for Immunotherapy With BCMA CAR-T Cells in Treating Patients With BCMA Positive Relapsed or Refractory Multiple Myeloma (NCT NCT03338972)

Last Updated: 2023-09-08

Results Overview

Observed DLT rates will be summarized based on the DLT-Evaluable analysis set. Outcome will be reported as count of participants in each arm who experienced a DLT. No patients received more than one CAR T cell infusion, so DLT assessment period was only 28 days after first and only CAR T infusion for all patients.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

28 participants

Primary outcome timeframe

Up to 28 days after CAR T cell infusion

Results posted on

2023-09-08

Participant Flow

3 patients withdrew consent after enrollment and did not move on to treatment. These 3 patients were not assigned to a dose level.

Participant milestones

Participant milestones
Measure	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1 Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 1 contains patients treated as dose level 1 (50 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2 Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 2 contains patients treated as dose level 2 (150 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3 Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 3 contains patients treated as dose level 3 (300 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4 Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 4 contains patients treated as dose level 4 (450 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis
Overall Study STARTED	7	8	7	3
Overall Study COMPLETED	5	7	7	3
Overall Study NOT COMPLETED	2	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1 Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 1 contains patients treated as dose level 1 (50 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2 Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 2 contains patients treated as dose level 2 (150 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3 Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 3 contains patients treated as dose level 3 (300 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4 Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 4 contains patients treated as dose level 4 (450 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis
Overall Study Death	1	1	0	0
Overall Study Withdrawal by Subject	1	0	0	0

Baseline Characteristics

Immunotherapy With BCMA CAR-T Cells in Treating Patients With BCMA Positive Relapsed or Refractory Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1 n=7 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 1 contains patients treated as dose level 1 (50 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2 n=8 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 2 contains patients treated as dose level 2 (150 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3 n=7 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 3 contains patients treated as dose level 3 (300 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4 n=3 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 4 contains patients treated as dose level 4 (450 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	1 Participants n=4 Participants	14 Participants n=21 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	11 Participants n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	9 Participants n=21 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	16 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	2 Participants n=4 Participants	23 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	21 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Region of Enrollment United States	7 participants n=5 Participants	8 participants n=7 Participants	7 participants n=5 Participants	3 participants n=4 Participants	25 participants n=21 Participants

PRIMARY outcome

Timeframe: Up to 28 days after CAR T cell infusion

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1 n=7 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 1 contains patients treated as dose level 1 (50 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2 n=8 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 2 contains patients treated as dose level 2 (150 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3 n=7 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 3 contains patients treated as dose level 3 (300 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4 n=3 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 4 contains patients treated as dose level 4 (450 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis
Dose-limiting Toxicities (DLT) Rate	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 28 days after CAR T-cell infusion

Toxicity graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1 n=7 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 1 contains patients treated as dose level 1 (50 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2 n=8 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 2 contains patients treated as dose level 2 (150 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3 n=7 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 3 contains patients treated as dose level 3 (300 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4 n=3 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 4 contains patients treated as dose level 4 (450 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis
Count of Patients That Experienced Adverse Events	7 Participants	8 Participants	7 Participants	3 Participants

SECONDARY outcome

Timeframe: Assessed from Baseline up to a maximum of 537 days

Persistence of CART cells is tested by qPCR in PBMC.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1 n=7 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 1 contains patients treated as dose level 1 (50 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2 n=8 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 2 contains patients treated as dose level 2 (150 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3 n=7 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 3 contains patients treated as dose level 3 (300 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4 n=3 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 4 contains patients treated as dose level 4 (450 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis
Duration of Persistence of Adoptively Transferred BCMA CAR-T Cells	134 Days Interval 104.0 to 182.0	110 Days Interval 64.0 to 169.0	386 Days Interval 282.0 to 537.0	236 Days Interval 133.0 to 309.0

SECONDARY outcome

Timeframe: Baseline up to Day 28

Population: CART cell migration to bone marrow was identified in all patients for whom a Day 28 bone marrow biopsy specimen was available (19 out of 19). In 6 cases, biopsy was not performed due to patient clinical status or bone marrow biopsy was attempted but no aspirate could be collected.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1 n=5 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 1 contains patients treated as dose level 1 (50 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2 n=7 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 2 contains patients treated as dose level 2 (150 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3 n=5 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 3 contains patients treated as dose level 3 (300 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4 n=2 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 4 contains patients treated as dose level 4 (450 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis
Number of Participants With Detectable BCMA CART Cell Migration to Primary Disease Site (Bone Marrow) at Day 28	5 Participants	7 Participants	5 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline up to 3 months after CART infusion

Number of patients with a best response of either complete response, stringent complete response, very good partial response or partial response, assessed using modified International Myeloma Working group response criteria.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1 n=7 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 1 contains patients treated as dose level 1 (50 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2 n=8 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 2 contains patients treated as dose level 2 (150 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3 n=7 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 3 contains patients treated as dose level 3 (300 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4 n=3 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 4 contains patients treated as dose level 4 (450 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis
Objective Response Rate (ORR)	7 Participants	8 Participants	7 Participants	3 Participants

SECONDARY outcome

Timeframe: Assessed up to 1 year after CART infusion

Outcome is reported as the count of participants who were alive at the 1 year post treatment mark and did not experience disease progression by the 1 year post treatment mark.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1 n=7 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 1 contains patients treated as dose level 1 (50 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2 n=8 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 2 contains patients treated as dose level 2 (150 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3 n=7 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 3 contains patients treated as dose level 3 (300 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4 n=3 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 4 contains patients treated as dose level 4 (450 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis
Progression-free Survival (PFS)	3 Participants	5 Participants	5 Participants	2 Participants

SECONDARY outcome

Timeframe: Assessed up to 1 year after CART infusion

Outcome is reported as a count of participants who were alive at the 1 year post-infusion timepoint.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1 n=7 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 1 contains patients treated as dose level 1 (50 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2 n=8 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 2 contains patients treated as dose level 2 (150 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3 n=7 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 3 contains patients treated as dose level 3 (300 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4 n=3 Participants Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 4 contains patients treated as dose level 4 (450 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis
Overall Survival (OS)	3 Participants	5 Participants	7 Participants	3 Participants

Adverse Events

Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1

Serious events: 5 serious events

Other events: 7 other events

Deaths: 4 deaths

Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2

Serious events: 8 serious events

Other events: 8 other events

Deaths: 3 deaths

Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3

Serious events: 5 serious events

Other events: 7 other events

Deaths: 0 deaths

Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1 n=7 participants at risk Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 1 contains patients treated as dose level 1 (50 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2 n=8 participants at risk Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 2 contains patients treated as dose level 2 (150 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3 n=7 participants at risk Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 3 contains patients treated as dose level 3 (300 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis	Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4 n=3 participants at risk Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 4 contains patients treated as dose level 4 (450 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	42.9% 3/7 • Number of events 3 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	37.5% 3/8 • Number of events 5 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	14.3% 1/7 • Number of events 1 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	33.3% 1/3 • Number of events 1 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Blood and lymphatic system disorders NEUTROPENIC FEVER	14.3% 1/7 • Number of events 2 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/8 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/7 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	33.3% 1/3 • Number of events 1 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Gastrointestinal disorders NAUSEA	0.00% 0/7 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	12.5% 1/8 • Number of events 1 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/7 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/3 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
General disorders FEVER	28.6% 2/7 • Number of events 4 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	62.5% 5/8 • Number of events 5 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	42.9% 3/7 • Number of events 4 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	33.3% 1/3 • Number of events 1 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Immune system disorders CYTOKINE RELEASE SYNDROME	0.00% 0/7 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/8 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	14.3% 1/7 • Number of events 1 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/3 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Infections and infestations INFECTIONS AND INFESTATIONS - OTHER, LYSINIBACILLUS	0.00% 0/7 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	12.5% 1/8 • Number of events 1 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/7 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/3 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Infections and infestations LUNG INFECTION	14.3% 1/7 • Number of events 1 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/8 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/7 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/3 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Infections and infestations UPPER RESPIRATORY INFECTION	0.00% 0/7 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	12.5% 1/8 • Number of events 1 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/7 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/3 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Renal and urinary disorders ACUTE KIDNEY INJURY	0.00% 0/7 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/8 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	14.3% 1/7 • Number of events 2 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/3 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
Vascular disorders HYPOTENSION	14.3% 1/7 • Number of events 1 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/8 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/7 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.	0.00% 0/3 • Adverse Events were assessed up to 28 days after CAR T-cell infusion. No patients received more than one CAR T cell infusion, so AE assessment period was only 28 days after first and only CAR T infusion for all patients. All-Cause Mortality was assessed up to 1 year. An Adverse Event (AE) is any undesirable experience associated with the use of a medical product in a patient. The NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.

Other adverse events

Additional Information

Dr. Damian Green

Fred Hutchinson Cancer Center

Phone: 2066675398

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place