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

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

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.

Sponsors & Collaborators

• The General Hospital of Western Theater Command

  collaborator OTHER

• Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai

  collaborator OTHER

• Shanghai Liquan Hospital

  collaborator OTHER

• Central People's Hospital of Zhanjiang

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• Beijing GoBroad Hospital

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-22

Primary Completion

2026-04-01

Completion

2028-03-30

Countries

• China

Study Locations