drugset / Trial / NCT07551778

Allogeneic NK Cell Therapy Combined With Standard Maintenance Treatment in Advanced Solid Tumors

NCT07551778

Phase 1/2 Not yet recruiting 20 enrolled BOE Technology Group Co., Ltd.
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

EvaluationDrugModalityDoseRoute
Subject TROCULEUCEL Cell therapy
Background Bevacizumab Monoclonal antibody
Background Capecitabine Small molecule
Background Cetuximab Monoclonal antibody
Background Pemetrexed Small molecule