drugset / Trial / NCT07551778
Allogeneic NK Cell Therapy Combined With Standard Maintenance Treatment in Advanced Solid Tumors
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a prospective, open-label, exploratory clinical study to evaluate the safety and preliminary efficacy of allogeneic natural killer (NK) cell injection combined with standard maintenance therapy in patients with locally advanced or metastatic solid tumors. The study consists of three cohorts: Cohort 1 (advanced non-squamous NSCLC with NK cells + PD-(L)1 inhibitor + pemetrexed), Cohort 2 (advanced colorectal adenocarcinoma with NK cells + cetuximab/bevacizumab + capecitabine), and Cohort 3 (lymphodepletion exploration cohort with fludarabine + cyclophosph preconditioning followed by NK cells + PD-(L)1 inhibitor + pemetrexed).
Timeline
- Start
- 2026-05
- Primary completion
- 2028-04
- Completion
- 2029-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NK cells | Cell therapy | — | — |
| Background | Bevacizumab | Monoclonal antibody | — | — |
| Background | Capecitabine | Small molecule | — | — |
| Background | Cetuximab | Monoclonal antibody | — | — |
| Background | Pemetrexed | Small molecule | — | — |