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Autologous and Donor-derived CD7 CAR-T Therapy in Refractory or Relapsed T-cell Malignancies
Sponsor: Beijing GoBroad Hospital
Summary
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.
Official title: Autologous and Donor-derived CD7 CAR T-cell Therapy in Refractory or Relapsed T-cell Malignancies: a Multi-center, Open-label, Phase Ⅰ/Ⅱ Clinical Trial
Key Details
Gender
All
Age Range
1 Year - 70 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2024-03-22
Completion Date
2028-03-30
Last Updated
2025-11-26
Healthy Volunteers
No
Conditions
Interventions
Autologous CD7 CAR T-cell
Peripheral blood mononuclear cells for the production of CD7 CAR T cells are collected from patients.
Prior-HSCT donor-derived CD7 CAR T-cell
Peripheral blood mononuclear cells for the production of CD7 CAR T cells are collected from prior-HSCT donors.
New donor-derived CD7 CAR T-cell
Peripheral blood mononuclear cells for the production of CD7 CAR T cells are collected from new donors.
Locations (4)
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China
Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine
Shanghai, Shanghai Municipality, China
Shanghai Liquan Hospital
Shanghai, Shanghai Municipality, China
The General Hospital of Western Theater Command PLA
Chengdu, Sichuan, China