{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"4"}]}],"title":"Hypophosphatemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"3"}]}],"title":"Confusion"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"4"}]}],"title":"Dyspnea (intubated)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"4"}]}],"title":"Ejection fraction decreased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"3"}]}],"title":"Encephalopathy"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"3"}]}],"title":"Hypoxia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"4"}]}],"title":"Acute kidney injury (CVVH)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"4"}]}],"title":"Sepsis (Staph Aureus)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"3"}]}],"title":"Muscle weakness lower limbs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"3"}]}],"title":"Muscle weakness upper limbs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"3"}]}],"title":"Platelet count decreased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"4"}]}],"title":"Neutrophil count decreased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"3"}]}],"title":"Acute kidney injury"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"4"}]}],"title":"Hypotension"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"4"}]}],"title":"CPK increased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"3"}]}],"title":"Musculoskeletal/connective tissue disorders-Rhabd."}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"16"}],"units":"Participants"}],"description":"Dose limiting toxicities are defined as follows: Grade 3 toxicities possibly or probably related to either the anti-BCMA CAR T cells or the fludarabine and cyclophosphamide chemotherapy and lasting more than 7 days. Grade 4 toxicities possibly or probably related to the study interventions.","groups":[{"description":"Dose Escalation with 5 dose levels based on the patients actual bodyweight\n\nCyclophosphamide: 300 mg/m\\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3\n\nFludarabine: 30 mg/m\\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3\n\nAnti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\\^6- 15.0x10\\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0","id":"OG000","title":"0.3 x 10^6 CAR-BCMA T-cells Infused"},{"description":"Dose Escalation with 5 dose levels based on the patients actual bodyweight\n\nCyclophosphamide: 300 mg/m\\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3\n\nFludarabine: 30 mg/m\\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3\n\nAnti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\\^6- 15.0x10\\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0","id":"OG001","title":"1 x 10^6 CAR-BCMA T-cells Infused"},{"description":"Dose Escalation with 5 dose levels based on the patients actual bodyweight\n\nCyclophosphamide: 300 mg/m\\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3\n\nFludarabine: 30 mg/m\\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3\n\nAnti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\\^6- 15.0x10\\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0","id":"OG002","title":"3 x 10^6 CAR-BCMA T-cells Infused"},{"description":"Dose Escalation with 5 dose levels based on the patients actual bodyweight\n\nCyclophosphamide: 300 mg/m\\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3\n\nFludarabine: 30 mg/m\\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3\n\nAnti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\\^6- 15.0x10\\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0","id":"OG003","title":"9 x 10^6 CAR-BCMA T-cells Infused"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"One participant in Group 9x10(6) did not get CAR T-cells and was deemed ineligible, and 3 participants in Group 9x10(6) were found to be ineligible for treatment.","reportingStatus":"POSTED","timeFrame":"After the start of treatment and up to 60 days","title":"Number of Participants With Dose Limiting Toxicities","type":"PRIMARY","unitOfMeasure":"Participants"}