Autologous and Donor-derived CD7 CAR-T Therapy in Refractory or Relapsed T-cell Malignancies

This is a multi-center, open-label, non-randomized, phase I/II trial. Patients with refractory or relapsed T-cell malignancies will receive autologous, prior-HSCT donor-derived or new donor-derived CD7 CAR T cells according to their HSCT history, peripheral blood leukemia burden and at their discretion. The primary objective is to learn about the safety of autologous, prior-HSCT donor-derived and new donor-derived CD7 CAR T-cell therapy in patients with refractory or relapsed T-cell acute lymphoblastic leukemia and lymphoma (r/r T-ALL/T-LBL) in phase I and to learn about the efficacy of autologous, prior-HSCT donor-derived and new donor-derived CD7 CAR T-cell therapy in patients with refractory or relapsed T-cell acute lymphoblastic leukemia and lymphoma (r/r T-ALL/T-LBL) in phase II. The primary endpoint is type and incidence of dose limiting toxicity (DLT) within 21 days after CD7 CAR T-cell infusion in phase I and overall response rate (ORR), which includes CR, CRh, CRi, MLFS, aplastic marrow for blood and bone marrow; central nervous system (CNS) remission; CR and PR for lymphomatous extramedullary disease according to National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2023 of Acute Lymphoblastic Leukemia at 3 months (± 1 week) post CD7 CAR T-cell infusion in refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells in phase II. A total number of 80 subjects will be enrolled.

NCT Number	NCT06316427
Lead Sponsor	Beijing GoBroad Hospital Collaborators: The General Hospital of Western Theater Command, Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, Shanghai Liquan Hospital, Central People's Hospital of Zhanjiang, First Affiliated Hospital of Guangxi Medical University
Conditions	T-cell Acute Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia, in Relapse, Refractory Acute Lymphoblastic Leukemia, T-cell Malignancies
Enrollment	80 participants
Start Date	2024-03-22
Primary Completion	2026-04-01 (estimated)
Study Completion	2028-03-30 (estimated)
Updated on ClinicalTrials.gov	2025-11-26