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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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 2
    NK cells + cetuximab/bevacizumab + capecitabine
  • Experimental: Cohort 3
    Lymphodepletion 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

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