Study Summary
The aim of this study was to evaluate the safety and efficacy of supCD7 CART cells in the treatment of patients with relapsed/refractory CD7-positive hematologic malignancies. In this single-arm, open-label, single-center, Phase Ⅰ+Ⅱ clinical trial, two cohorts were set up: (1) relapsed and refractory AML cohort; and (2) relapsed and refractory T-ALL/LBL cohort. Each cohort was planned to enroll 4-12 patients. SupCD7 CART cells will be administered intravenously to explore the MTD of each cohort using a 3+3 dose escalation and rapid titration design.
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supCD7 CART cellsBIOLOGICAL
Subjects screened to meet the requirements for supCD7 CART cells use will enter clinical trials. Subjects were assessed at baseline. Fludarabine and cyclophosphamide based preconditioning should be performed within 1 week prior to supCD7 CART cells infusion: fludarabine (Flu) 30mg/m2 ×3 days; cyclophosphamide (CTX) 500mg/m2 ×3 days. The investigator can adjust the pretreatment regimen appropriately according to the condition of the subject, such as increasing the dose of CTX to 600mg/m2 ×3 days, increasing the application of cytarabine and VP-16. Infusion of supCD7 CART cells must be performed 24 hours after completion of chemotherapy preconditioning. supCD7 CART cells can be infused at D-1 if the requirement of 24 hours after completion of preconditioning is met.
Study Locations
| Facility | City | State | Country |
|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital | Tianjin | Tianjin Municipality | China |