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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Dose-limiting toxicity(DLT) Any toxicity associated with uCD7 CAR-T cells, or life-threatening hematological or non-hematological toxicity.
Timeframe: 3 months after uCD7 CART cells infusion
Number of adverse event of CD7 CART cells treatment
Timeframe: Participants will be followed for the duration of the treatment, an expected average of 24 months.