{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"8"},{"groupId":"OG006","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"8"},{"groupId":"OG006","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 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":"OG000","title":"Arm 1 Dose Escalation (Esc) Dose Level 1 - 0.75x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg"},{"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":"OG001","title":"Arm 1 Dose Escalation Dose Level 2 - 1.5x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg"},{"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":"OG002","title":"Arm 1 Dose Escalation Dose Level 3 - 3.0x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg"},{"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":"OG003","title":"Arm 1 Dose Escalation Dose Level 4 - 6.0x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg"},{"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":"OG004","title":"Arm 1 Dose Escalation Dose Level 5 - 12.0x1^06 Chimeric Antigen Receptor (CAR)+ T Cells Per kg"},{"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":"OG005","title":"Arm 2 Dose Expansion (Exp) 6.0x10^6 Chimeric Antigen Receptor (CAR)+ T Cells Per kg"},{"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":"OG006","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"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"9/35 participants were enrolled but not treated.","reportingStatus":"POSTED","timeFrame":"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.","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"}