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Autologous and Donor-derived CD7 CAR-T Therapy in Refractory or Relapsed T-cell Acute Lymphoblastic Leukemia/Lymphoma

Refractory Acute Lymphoblastic Leukemia Clinical Trial

Official title:
Autologous and Donor-derived CD7 CAR T-cell Therapy in Refractory or Relapsed T-cell Acute Lymphoblastic Leukemia/Lymphoma: a Single-center, Open-label, Phase Ⅰ/Ⅱ Clinical Trial

Clinical Trial Summary

This is a single-center, open-label, non-randomized, phase I/II trial. Patients with refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL) 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Acute Lymphoblastic Leukemia, in Relapse
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
  • Refractory Acute Lymphoblastic Leukemia
  • T-cell Acute Lymphoblastic Leukemia
Clinical Trial Details
NCT number NCT06316427
Study type Interventional
Source Beijing GoBroad Hospital
Contact Tengyu Wang
Phone 86+18333186020
Email tengyu.wang@gohealtharo.com
Status Recruiting
Phase Phase 1/Phase 2
Start date March 22, 2024
Completion date March 30, 2028
View Details
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