drugset / Trial / NCT06097962
Safety and Efficacy of NK510 to Treat NSCLC
Phase 0
Recruiting
12 enrolled
Base Therapeutics (Shanghai) Co., Ltd.
Jinling Hospital, China · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — | — |