Phase 1 Allogeneic NK Cell Therapy Combined With Standard Maintenance Treatment in Advanced Solid Tumors
Summary
A prospective, open-label, exploratory Phase 1 clinical study (NCT07551778) evaluating the safety and preliminary efficacy of allogeneic natural killer (NK) cell injection combined with standard maintenance therapy across three cohorts: advanced non-squamous NSCLC, advanced colorectal adenocarcinoma, and a lymphodepletion exploration cohort. The trial enrolled patients with locally advanced or metastatic solid tumors as of April 27, 2026. This registry entry documents the study design and does not impose compliance obligations on any party.
“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.”
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What changed
ClinicalTrials.gov registered a new prospective, open-label, exploratory Phase 1 study to evaluate allogeneic NK cell injection combined with standard maintenance therapy across three cohorts: Cohort 1 (advanced non-squamous NSCLC with NK cells plus PD-(L)1 inhibitor and pemetrexed), Cohort 2 (advanced colorectal adenocarcinoma with NK cells plus cetuximab/bevacizumab and capecitabine), and Cohort 3 (lymphodepletion exploration cohort with fludarabine and cyclophosphamide preconditioning followed by NK cells plus PD-(L)1 inhibitor and pemetrexed). The study targets patients with locally advanced or metastatic solid tumors.
Affected parties include clinical investigators conducting oncology cell therapy research and sponsors of NK cell therapy programs. This registry entry provides protocol transparency but does not create regulatory obligations. Sponsors and clinical sites monitoring competitive landscape in cellular therapy should note this entry for trial design benchmarking.
Archived snapshot
Apr 28, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Allogeneic NK Cell Therapy Combined With Standard Maintenance Treatment in Advanced Solid Tumors
Phase 1 NCT07551778 Kind: PHASE1 Apr 27, 2026
Abstract
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).
Conditions: NSCLC (Advanced Non-small Cell Lung Cancer), Colorectal Cancer, Advanced Solid Tumors
Interventions: NK Cells, NK cells + PD-(L)1 inhibitor + pemetrexed as first-line maintenance therapy, NK cells + cetuximab/bevacizumab + capecitabine as first-line maintenance therapy
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