NCT06316427

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

Recruiting now Phase 1, PHASE2 Last updated 26 November 2025

What this trial tests

Phase 1, PHASE2 trial testing Autologous CD7 CAR T-cell in T-cell Acute Lymphoblastic Leukemia in 80 participants. Currently enrolling.

Timeline

22 March 2024

Primary endpoint
1 April 2026

30 March 2028

Quick facts

Lead sponsor	Beijing GoBroad Hospital
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	22 March 2024
Primary completion	1 April 2026
Estimated completion	30 March 2028
Sites	4 locations across China

Drugs / interventions tested

• Autologous CD7 CAR T-cell — full drug profile →
• Prior-HSCT donor-derived CD7 CAR T-cell — full drug profile →
• New donor-derived CD7 CAR T-cell — full drug profile →

Conditions studied

• T-cell Acute Lymphoblastic Leukemia — all drugs for T-cell Acute Lymphoblastic Leukemia →
• Acute Lymphoblastic Leukemia, in Relapse — all drugs for Acute Lymphoblastic Leukemia, in Relapse →
• Refractory Acute Lymphoblastic Leukemia — all drugs for Refractory Acute Lymphoblastic Leukemia →
• T-cell Malignancies — all drugs for T-cell Malignancies →

Sponsor

Beijing GoBroad Hospital

Who can join

Adults 1 to 70, any sex, with T-cell Acute Lymphoblastic Leukemia or Acute Lymphoblastic Leukemia, in Relapse. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mechanisms of Resistance to CAR T-Cells and How to Overcome Them.
   Legato L, Bisio M, Fasano F, Benevolo Savelli C, et al · · 2025 · cited 3× · PMID 40981226 · DOI 10.3390/mps8050108
2. CAR-T Therapy Beyond B-Cell Hematological Malignancies.
   Canichella M, de Fabritiis P. · · 2025 · cited 1× · PMID 39791742 · DOI 10.3390/cells14010041
3. Have CARs stalled for non-B-cell malignancies? Where are we, and where are we going?
   Silbert S, Lamble A. · · 2025 · PMID 41347986 · DOI 10.1182/hematology.2025000733
4. Publication Only
   · 2025