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RECRUITING
NCT06316427
PHASE1/PHASE2

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

Sponsor: Beijing GoBroad Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

Autologous CD7 CAR T-cell

Peripheral blood mononuclear cells for the production of CD7 CAR T cells are collected from patients.

DRUG

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.

DRUG

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