NCT05290155

Anti-CD7 CAR-T Cell Therapy for Relapse and Refractory CD7 Positive T Cell Malignancies

The Safety and Clinical Efficacy of Human CD7 CAR-T Cell Therapy for Patients With Relapsed/Refractory CD7 Positive T Cell Hematological Maliganacies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 14 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of CAR T cell treatment targeting CD7 in patients with relapsed or refractory CD7 positive T-cell hematological maliganacies

Detailed description

This study is single-armed，open lable，dose escalation clinical trial.The main purpose is to evaluate the safety and efficacy of anti-CD7 CAR-T cells in relapsed/refractory patients with CD7 positive T cell malignancies,including T lymphoblastic lymphoma/leukemia ,T-cell non-Hodgkin lymphoma(peripheral T cell lymphoma,NOS,angioimmunoblastic T cell lymphoma and anaplastic large cell lymphoma).There will be three CAR T cell dose groups:0.25\*10\^6 cells per kilogram of body weight;0.5\*10\^6 cells per kilogram of body weight，1 \*10\^6 ells per kilogram of body weight.

Conditions

• T Lymphoblastic Leukemia/Lymphoma
• T-cell Acute Lymphoblastic Leukemia
• Peripheral T Cell Lymphoma
• Angioimmunoblastic T-cell Lymphoma
• Anaplastic Large Cell Lymphoma

Interventions

Type	Name	Description
DRUG	anti-CD7 CAR-T cells	Administration with anti-CD7 CAR-T cells in the relapsed/refractory T cell hematological malignancy patients

Timeline

• Start date: 2022-05-04
• Primary completion: 2024-08-01
• Completion: 2025-05-01
• First posted: 2022-03-22
• Last updated: 2025-06-06

Locations

1 site across 1 country: China