NCT05626400

Clinical Study of Senl-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ Acute T-ALL/T-LBL

Clinical Study of Senl-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ Acute T Lymphoblastic Leukemia and T Lymphoblastic Lymphoma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Hebei Senlang Biotechnology Inc., Ltd. · Industry
• Sex: All
• Age: 2 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an open, prospective, dose-escalation clinical study to evaluate the safety and efficacy of Senl-T7 in patients with relapsed or refractory CD7+ acute T lymphoblastic leukemia or T lymphoblastic lymphoma.Meanwhile, PK/PD indexes of Senl-T7 were collected.

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.

Conditions

• T-cell Acute Lymphoblastic Leukemia/Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Senl-T7	Patients will be treated with CD7 CAR-T cells

Timeline

• Start date: 2022-08-29
• Primary completion: 2027-10-30
• Completion: 2027-12-30
• First posted: 2022-11-23
• Last updated: 2022-11-25

Locations

1 site across 1 country: China