NCT06454890

Clinical Study of Trop2 CAR-NK in the Treatment of Relapsed/Refractory Non-Small Cell Lung Cancer (NSCLC)

An Investigator-initiated Trial Evaluating the Efficacy and Safety of Anti-Trop2 Universal CAR-NK(U-CAR-NK) Cells Therapy Combined With Chemotherapy for Relapsed/Refractory Non-Small Cell Lung Cancer (NSCLC)

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

It is a single-center, open-labeled, single-arm, non-randomized investigator-initiated trial evaluating the efficacy and safety of anti-Trop2 U-CAR-NK Cells Therapy combined with Chemotherapy for Relapsed/Refractory Non-Small Cell Lung Cancer (NSCLC).

Detailed description

Who can participate? Patients who were diagnosed with Non-Small Cell Lung Cancer and tumor cells expressing Trop2. How to conduct this study? This study is an interventional clinical study. The intervention in the trial is anti-Trop2 U-CAR-NK cells. The administration time is 5 days after chemotherapy. Patients were then evaluated efficacy and safety until 3 years after U-CAR-NK cells infusion. What are the possible benefits and risks of participating? Benefits: The effect of anti-tumor of NK cells may be used to disease control. Risks: Subjects may have adverse reactions to the treatment. These adverse reactions may include abnormal liver injury, fever, and possibly other unknown adverse reactions. Where is the study run? Henan Cancer Hospital.

Conditions

• Non-Small Cell Lung Cancer NSCLC

Interventions

Type	Name	Description
BIOLOGICAL	Anti-Trop2 CAR-NK cell	chemotherapy followed by Trop2 CAR-NK infusion

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-07-31
• Completion: 2029-07-31
• First posted: 2024-06-12
• Last updated: 2024-06-12