NCT05554575

Chimeric Antigen Receptor T-Cell (CAR-T) Cells in Patients With R/R T-LBL

Safety and Efficacy of BT-007 CAR-T Cells in the Treatment of Patients With Relapsed/Refractory T Cell Lymphoblastic Lymphoma (R/R T-LBL)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Bioceltech Therapeutics, Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single center, single arm, open-lable phase I study to determine the safety and efficacy of T cells expressing CD7 chimeric antigen receptors (referred to as "BT-007 CAR-T cells") in patients with relapsed or refractory acute T cell lymphoblastic lymphoma (R/R T-LBL).

Detailed description

Primary objective: To investigate the safety and efficacy of CD7 CAR-T cells in the treatment of patients with relapsed or refractory acute T cell lymphoblastic lymphoma (R/R T-LBL). Secondary objective: To assess the patient's quality of life after receiving the treatment.

Conditions

• T Cell Lymphoblastic Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	BT-007 CD7 CAR-T cells	T cells purified from the peripheral blood mononuclear cell (PBMC) of subjects or subjects' relatives which depend on their conditions, transduced with 4-1BB/CD3ζ lentiviral vector, expanded in vitro for future administration.

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2022-09-26
• Last updated: 2022-09-26

Locations

1 site across 1 country: China