NCT04599556

Clinical Trial for the Safety and Efficacy of Anti-CD7 CAR-T Cell Therapy for Patients With Relapsed or Refractory CD7 Positive Hematological Malignancy

Status unknown Phase 1 Last updated 6 December 2023

What this trial tests

Phase 1 trial testing anti-CD7 CAR-T in CD7+ Acute Leukemia in 81 participants. Status unknown.

Timeline

1 April 2021

Primary endpoint
30 December 2023

30 December 2025

Quick facts

Lead sponsor	Zhejiang University
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	81
Start date	1 April 2021
Primary completion	30 December 2023
Estimated completion	30 December 2025
Sites	1 location across China

Drugs / interventions tested

• anti-CD7 CAR-T — full drug profile →

Conditions studied

• CD7+ Acute Leukemia — all drugs for CD7+ Acute Leukemia →
• CD7+ Lymphoma — all drugs for CD7+ Lymphoma →

Sponsor

Zhejiang University

Who can join

Adults 3 to 80, any sex, with CD7+ Acute Leukemia or CD7+ Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective, open-label, single-center clinical trial. This study will evaluate the safety and efficacy of anti-CD7 CAR-T cells in the treatment of relapsed or refractory CD7 positive T-ALL/LBL, T-NHL and AML. The primary endpoints are dose limiting toxicity (DLT) and the incidence of treatment emergent adverse event (TEAE).

Publications & conference data

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

1. Sequential CD7 CAR T-Cell Therapy and Allogeneic HSCT without GVHD Prophylaxis.
   Hu Y, Zhang M, Yang T, Mo Z, et al · · 2024 · cited 92× · PMID 38657244 · DOI 10.1056/nejmoa2313812
2. A deep insight into CRISPR/Cas9 application in CAR-T cell-based tumor immunotherapies.
   Razeghian E, Nasution MKM, Rahman HS, Gardanova ZR, et al · · 2021 · cited 80× · PMID 34321099 · DOI 10.1186/s13287-021-02510-7
3. Chimeric antigen receptor T (CAR-T) cells: Novel cell therapy for hematological malignancies.
   Abbasi S, Totmaj MA, Abbasi M, Hajazimian S, et al · · 2023 · cited 64× · PMID 36583504 · DOI 10.1002/cam4.5551
4. Emerging Trends in Immunotherapy for Cancer.
   Mishra AK, Ali A, Dutta S, Banday S, et al · · 2022 · cited 41× · PMID 36135216 · DOI 10.3390/diseases10030060
5. Novel antigens of CAR T cell therapy: New roads; old destination.
   Safarzadeh Kozani P, Safarzadeh Kozani P, Rahbarizadeh F. · · 2021 · cited 31× · PMID 33862524 · DOI 10.1016/j.tranon.2021.101079
6. Chimeric antigen receptor T-cell therapy for T-ALL and AML.
   Wei W, Yang D, Chen X, Liang D, et al · · 2022 · cited 20× · PMID 36523990 · DOI 10.3389/fonc.2022.967754
7. Current state of CAR-T therapy for T-cell malignancies.
   Luo L, Zhou X, Zhou L, Liang Z, et al · · 2022 · cited 19× · PMID 36601636 · DOI 10.1177/20406207221143025
8. CAR T-Cell Immunotherapy Treating T-ALL: Challenges and Opportunities.
   Ren A, Tong X, Xu N, Zhang T, et al · · 2023 · cited 17× · PMID 36680011 · DOI 10.3390/vaccines11010165