NCT04572308

Cell Therapy for CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD7-Specific CAR-T Cells

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Hebei Senlang Biotechnology Inc., Ltd. · Industry
• Sex: All
• Age: 2 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD7 CAR-T cell in the treatment of relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) and lymphoblastic lymphoma (TLBL).

Detailed description

The CARs consist of an anti-CD7 single-chain variable fragment（scFv）, a portion of the human CD137（4-1BB） molecule, and the intracellular component of the human CD3ζ molecule. Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy. The Main research objectives: To evaluate the safety and efficacy of CD7 CAR-T cells in patients with relapsed or refractory T-ALL/LBL The Secondary research objectives: To investigate the cytokinetic characteristics of CD7 CAR-T cells in patients with relapsed or refractory T-ALL/LBL

Conditions

• T-cell Acute Lymphoblastic Leukemia/Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	CD7 CAR-T	Patients will be treated with CD7 CAR-T cells Biological: CD7 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;

Timeline

• Start date: 2020-10-01
• Primary completion: 2021-05-30
• Completion: 2021-05-30
• First posted: 2020-10-01
• Last updated: 2021-06-29

Locations

1 site across 1 country: China