Study Summary
The aim of this study was to evaluate the safety and efficacy of universal CD7 CART (uCD7 CART) cells in the treatment of patients with relapsed/refractory CD7-positive hematologic malignancies. In this single-arm, open-label, single-center, Phase 1 clinical trial, two cohorts were set up: (1) relapsed and refractory acute myeloid leukemia (AML) cohort; and (2) relapsed and refractory T lymphoblastic leukemia/lymphoma (T-ALL/LBL) cohort. Each cohort was planned to enroll 4-12 patients. uCD7 CART cells will be administered intravenously to explore the maximum tolerated dose (MTD) of each cohort using a 3+3 dose escalation and rapid titration design.
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uCD7 CARTBIOLOGICAL
Subjects screened to meet the requirements for uCD7 CART use will enter clinical trials. Subjects were assessed at baseline. Fludarabine (Flu) and cyclophosphamide (CTX) based preconditioning should be performed within 1 week prior to uCD7 CART infusion: Flu 30mg/m2 ×3 days; 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 etoposide. Infusion of uCD7 CART must be performed 24 hours after completion of chemotherapy preconditioning. uCD7 CART 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 |