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 Hepatocellular Carcinoma (HCC)
  • Advanced Solid Tumors
  • Colorectal Cancer
  • GC/GEJC
  • NSCLC (Advanced Non-small Cell Lung Cancer)

Eligibility Criteria

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

Interventions

  • NK Cells — BIOLOGICAL
    Administered according to standard clinical practice and product labeling
  • NK cells + PD-(L)1 inhibitor + pemetrexed as first-line maintenance therapy — BIOLOGICAL
    3-week cycles
  • NK cells + cetuximab/bevacizumab + capecitabine as first-line maintenance therapy — BIOLOGICAL
    2-week cycles
  • NK cells + PD-(L)1 inhibitor + VEGF inhibitor as first-line maintenance therapy — BIOLOGICAL
    3-week cycles
  • NK cells + PD-(L)1 inhibitor + capecitabine or S-1 as first-line maintenance therapy — BIOLOGICAL
    2-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 5 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), Cohort 3 (lymphodepletion exploration cohort with fludarabine + cyclophosph preconditioning followed by NK cells + PD-(L)1 inhibitor + pemetrexed), Cohort 4 (advanced HCC with NK cells + VEGF + PD-(L)1), and Cohort 5 (advanced GC with NK cells + PD-(L)1 + S-1).

Key Dates

First listed
Apr 27, 2026
Start date
Aug 31, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
42 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
  • Experimental: Cohort 4
    NK+ PD-(L)1 + VEGF inhibitor
  • Experimental: Cohort 5
    NK +PD-(L)1+ chemotherapy

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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