{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"1"}],"units":"Participants"}],"description":"Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.","groups":[{"description":"Participants who have not had an allogeneic hematopoietic stem cell transplant. 0.3x10\\^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight\n\nStarting dose: 0.3x10\\^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m\\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m\\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3","id":"OG000","title":"Dose Escalation Cohort 1 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg"},{"description":"Participants who have not had an allogeneic hematopoietic stem cell transplant. 1.0x10\\^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight\n\n1.0x10\\^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m\\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m\\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3","id":"OG001","title":"Dose Escalation Cohort 1 Dose Level 2 - 1.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg"},{"description":"Participants who have not had an allogeneic hematopoietic stem cell transplant. 3.0x10\\^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight\n\n3.0x10\\^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: This chemotherapy dose was changed part-way through the protocol, thus 4 participants received 500 mg/m\\^2 and 3 participants received 300 mg/m\\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m\\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3.","id":"OG002","title":"Dose Escalation Cohort 1 Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg"},{"description":"Participants who have not had an allogeneic hematopoietic stem cell transplant. 9.0x10\\^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight\n\n9.0x10\\^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 500 mg/m\\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m\\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3","id":"OG003","title":"Dose Escalation Cohort 1 Dose Level 4 - 9.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg"},{"description":"Participants who have had an Human Leukocyte Antigen (HLA)-matched sibling or an 8/8-HLA-matched unrelated donor transplant.\n\n1.0x10\\^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight\n\n1.0 x10\\^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m\\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m\\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3","id":"OG004","title":"Dose Escalation Cohort 2 Dose Level 1 - 0.3x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg"},{"description":"Participants who have had an Human Leukocyte Antigen (HLA)-matched sibling or an 8/8 HLA-matched unrelated donor transplant.\n\n3.0x10\\^6 Chimeric Antigen Receptor (CAR) T cells per kg of recipient bodyweight\n\n3.0x10\\^6 Chimeric Antigen Receptor (CAR)+ T cells/kg (weight based dosing) infuse on day 0 and Cyclophosphamide: 300 mg/m\\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 and Fludarabine: 30 mg/m\\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3","id":"OG005","title":"Dose Escalation Cohort 2 Dose Level 2 - 3.0x10^6 Chimeric Antigen Receptor (CAR) T Cells Per kg"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Date treatment consent signed to date off study, approximately 11 months and 26 days, 7 months and 10 days, 39 months and 7 days, 17 months and 3 days, 6 months and 15 days, and 1 month and 7 days for each group respectively.","title":"Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)","type":"OTHER_PRE_SPECIFIED","unitOfMeasure":"Participants"}