Allogeneic NK Cell Therapy Combined With Standard Maintenance Treatment in Advanced Solid Tumors
NCT07551778 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-04-27
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).
Conditions
- NSCLC (Advanced Non-small Cell Lung Cancer)
- Colorectal Cancer
- Advanced Solid Tumors
Interventions
- BIOLOGICAL
-
NK Cells
Administered according to standard clinical practice and product labeling
- BIOLOGICAL
-
NK cells + PD-(L)1 inhibitor + pemetrexed as first-line maintenance therapy
3-week cycles
- BIOLOGICAL
-
NK cells + cetuximab/bevacizumab + capecitabine as first-line maintenance therapy
2-week cycles
Sponsors & Collaborators
-
BOE Technology Group Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-31
- Primary Completion
- 2028-04-30
- Completion
- 2029-04-30
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