NCT04689659

Multi-centers, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Donor-Derived CD7 CAR T Cells in Subjects With Relapsed or Refractory T-cell Leukemia/Lymphoma

Completed Phase 2 Last updated 18 May 2025

What this trial tests

Phase 2 trial testing chimeric antigen receptor T cell treatment in T-cell Leukemia/Lymphoma in 55 participants. Completed in 3 April 2024.

Timeline

1 December 2021

Primary endpoint
3 April 2024

3 April 2024

Quick facts

Lead sponsor	Beijing Boren Hospital
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	55
Start date	1 December 2021
Primary completion	3 April 2024
Estimated completion	3 April 2024
Sites	1 location across China

Drugs / interventions tested

• chimeric antigen receptor T cell treatment — full drug profile →

Conditions studied

• T-cell Leukemia/Lymphoma — all drugs for T-cell Leukemia/Lymphoma →
• Refractory T Lymphoblastic Leukemia/Lymphoma — all drugs for Refractory T Lymphoblastic Leukemia/Lymphoma →
• Relapse/Recurrence — all drugs for Relapse/Recurrence →

Sponsor

Beijing Boren Hospital

Who can join

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

Sponsor's own description

This is a multi-centers, single-arm, open label, Phase 2 clinical trial to evaluate the efficacy and safety of CD7 CAR T cells in subjects with relapsed or refractory T-cell leukemia/lymphoma. Seventy subjects will be enrolled. CD7 CAR T cells will be given once intravenously at one dose (1×106, with an allowance of ± 20%) in patients received previous HSCT donor-derived CAR T cells. Patients who received fresh donor derived CD7 CAR T cells were given initial dose of 1×106, with an allowance of ± 20%. The dose levels may be adjusted during the study based on the specific number of cells on the day of fresh CAR T cells infusion, due to at this time all the patients have completed lymphodepleting, so we adopt the allowance of ±20% for each group of absolute infusion cells. And patients who were lower than the designed dose group were also given infusion, but they will be either assigned to the lower dose group or exclude from safety analysis of designed dose group.

Publications & conference data

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

1. Donor-Derived CD7 Chimeric Antigen Receptor T Cells for T-Cell Acute Lymphoblastic Leukemia: First-in-Human, Phase I Trial.
   Pan J, Tan Y, Wang G, Deng B, et al · · 2021 · cited 223× · PMID 34324392 · DOI 10.1200/jco.21.00389
2. Current updates on generations, approvals, and clinical trials of CAR T-cell therapy.
   Asmamaw Dejenie T, Tiruneh G/Medhin M, Dessie Terefe G, Tadele Admasu F, et al · · 2022 · cited 105× · PMID 36094837 · DOI 10.1080/21645515.2022.2114254
3. Genome-edited allogeneic donor "universal" chimeric antigen receptor T cells.
   Qasim W. · · 2023 · cited 48× · PMID 36223560 · DOI 10.1182/blood.2022016204
4. Tumor buster - where will the CAR-T cell therapy 'missile' go?
   Qu C, Zhang H, Cao H, Tang L, et al · · 2022 · cited 44× · PMID 36261831 · DOI 10.1186/s12943-022-01669-8
5. Recent Advances in Treatment Options for Childhood Acute Lymphoblastic Leukemia.
   Malczewska M, Kośmider K, Bednarz K, Ostapińska K, et al · · 2022 · cited 40× · PMID 35454927 · DOI 10.3390/cancers14082021
6. Mechanisms of immune effector cell-associated neurotoxicity syndrome after CAR-T treatment.
   Gu T, Hu K, Si X, Hu Y, et al · · 2022 · cited 36× · PMID 35871757 · DOI 10.1002/wsbm.1576
7. Adult Acute Lymphoblastic Leukemia: 2025 Update on Diagnosis, Therapy, and Monitoring.
   Kantarjian H, Jabbour E. · · 2025 · cited 27× · PMID 40377367 · DOI 10.1002/ajh.27708
8. Development of CAR T Cell Therapy in Children-A Comprehensive Overview.
   Boettcher M, Joechner A, Li Z, Yang SF, et al · · 2022 · cited 23× · PMID 35456250 · DOI 10.3390/jcm11082158