Allogeneic NK Cell Therapy Combined With Standard Maintenance Treatment in Advanced Solid Tumors
- Sponsor
- BOE Technology Group Co., Ltd.
- Study ID
- NCT07551778
- Phase
- PHASE1/PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Advanced Solid Tumors
- Colorectal Cancer
- NSCLC (Advanced Non-small Cell Lung Cancer)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- NK Cells — BIOLOGICALAdministered according to standard clinical practice and product labeling
- NK cells + PD-(L)1 inhibitor + pemetrexed as first-line maintenance therapy — BIOLOGICAL3-week cycles
- NK cells + cetuximab/bevacizumab + capecitabine as first-line maintenance therapy — BIOLOGICAL2-week cycles
Study Details
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).
Key Dates
- First listed
- Apr 27, 2026
- Start date
- May 31, 2026
- Status verified
- Apr 2026
- Primary completion
- Apr 30, 2028
- Completion
- Apr 30, 2029
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Cohort 1:NK cells + PD-(L)1 inhibitor + pemetrexed
- Experimental: Cohort 2NK cells + cetuximab/bevacizumab + capecitabine
- Experimental: Cohort 3Lymphodepletion exploration cohort
Primary Outcome Measure
Dose-Limiting Toxicity (DLT) [ Time Frame: During the first treatment cycle (21 days for Cohorts 1&3, 14 days for Cohort 2) ]
Central Contacts
- Ning Li, MD, PhD0316-5918497
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