drugset / Trial / NCT06097962

Safety and Efficacy of NK510 to Treat NSCLC

NCT06097962

Non-randomizedSequentialOpen-labelTreatment

Summary

This study assesses the safety and efficacy of NK510 combined with PD-(L)1 inhibitors for relapsed/refractory advanced NSCLC, with two administration routes: intravenous infusion and intrapleural perfusion for malignant pleural effusion. Eligible patients need confirmed measurable lesions; intravenous cohort requires EGFR/ROS1/ALK negativity and disease progression after PD-(L)1 inhibitor treatment, while intrapleural cohort accepts targeted therapy-resistant patients with ≥500ml pleural effusion, and the treatment's safety, efficacy and immune microenvironment changes will be evaluated.

Timeline

Start
2023-07-01
Primary completion
2026-07-01
Completion
2026-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject NK510 Cell therapy 3e+09 cells Intravenous
Subject NK510 Cell therapy 6e+09 cells Intravenous
Subject NK510 Cell therapy 9e+09 cells Intravenous
Subject NK510 Cell therapy 1.2e+10 cells Intravenous
Background Atezolizumab Monoclonal antibody
Background Sugemalimab Monoclonal antibody
Background Tislelizumab Monoclonal antibody