{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"3"}],"units":"Participants"}],"description":"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.","groups":[{"description":"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).\n\nArm 1 contains patients treated as dose level 1 (50 x 10\\^6 EGFRt cells)\n\nAutologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV\n\nCyclophosphamide: Given IV\n\nFludarabine: Given IV\n\nLeukapheresis: Undergo leukapheresis","id":"OG000","title":"Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1"},{"description":"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).\n\nArm 2 contains patients treated as dose level 2 (150 x 10\\^6 EGFRt cells)\n\nAutologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV\n\nCyclophosphamide: Given IV\n\nFludarabine: Given IV\n\nLeukapheresis: Undergo leukapheresis","id":"OG001","title":"Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2"},{"description":"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).\n\nArm 3 contains patients treated as dose level 3 (300 x 10\\^6 EGFRt cells)\n\nAutologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV\n\nCyclophosphamide: Given IV\n\nFludarabine: Given IV\n\nLeukapheresis: Undergo leukapheresis","id":"OG002","title":"Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3"},{"description":"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).\n\nArm 4 contains patients treated as dose level 4 (450 x 10\\^6 EGFRt cells)\n\nAutologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV\n\nCyclophosphamide: Given IV\n\nFludarabine: Given IV\n\nLeukapheresis: Undergo leukapheresis","id":"OG003","title":"Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Up to 28 days after CAR T-cell infusion","title":"Count of Patients That Experienced Adverse Events","type":"PRIMARY","unitOfMeasure":"Participants"}