NCT06909474

Clinical Trial of CD5-targeted CAR-NK Therapy for Relapse/Refractory T-Cell Hematologic Malignancies

Clinical Study of CD5 Targeting Chimeric Antigen Receptor NK Cells (CAR-NK) in the Treatment of Relapse/Refractory T-Cell Hematologic Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Chongqing Precision Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a clincal trial initiated by investigator to evaluate the safety and efficacy of anti-CD5 CAR-NK in the treatment of patients with relapsed/refractory T-Cell hematologic malignancies.

Detailed description

This study is a single-arm, open-label, dose-finding and expansion clinical trial aimed at evaluating the safety and efficacy of anti-CD5 CAR-NK therapy for the treatment of patients with relapsed/refractory T-Cell hematologic malignancies. The goal is to determine the recommended dose of CAR-NK cell therapy for these conditions. The study includes three dose groups: 1×10⁷ CAR-positive cells/kg, 3×10⁷ CAR-positive cells/kg, and 5×10⁷ CAR-positive cells/kg. Each patient will initially receive a single infusion of CAR-NK cells on Day 0. If a suboptimal response is observed after the first infusion (assessed by Day 28) and the safety profile remains acceptable, a second infusion may be administered as a remedial dose after Day 28. The investigaors have the flexibility to adjust the second infusion dose based on the subject's condition.

Conditions

• T-ALL/Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Anti-CD5 CAR NK cells	Each patient will initially receive a single infusion of CAR-NK cells on Day 0. If a suboptimal response is observed after the first infusion (assessed by Day 28) and the safety profile remains acceptable, a second infusion may be administered as a remedial dose after Day 28. CAR-NK cells need to be controlled within 70 minutes from thawing to infusion completion.

Timeline

• Start date: 2025-03-27
• Primary completion: 2027-03-31
• Completion: 2028-03-31
• First posted: 2025-04-03
• Last updated: 2025-04-03

Locations

1 site across 1 country: China