NCT06316427

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Beijing GoBroad Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• T-cell Acute Lymphoblastic Leukemia
• Acute Lymphoblastic Leukemia, in Relapse
• Refractory Acute Lymphoblastic Leukemia
• T-cell Malignancies

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-03-22
• Primary completion: 2026-04-01
• Completion: 2028-03-30
• First posted: 2024-03-18
• Last updated: 2025-11-26

Locations

4 sites across 1 country: China