Clinical Trial

uCD7 CART for Relapsed or Refractory CD7 Positive Hematologic Malignancies

Recruiting Phase 1
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-31.
Trial Details
NCT Number NCT07109518
Lead Sponsor Institute of Hematology & Blood Diseases Hospital, China
Conditions Acute Myeloid Leukemia (AML), T Lymphoblastic Leukemia/Lymphoma
Enrollment 12 participants
Start Date 2025-06-28
Primary Completion 2028-06-28 (estimated)
Study Completion 2030-06-28 (estimated)
Updated on ClinicalTrials.gov 2025-09-03