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).
Age 18-75 years, either gender
Histologically/cytologically confirmed locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (Stage IIIB~IV), without known drug-targetable driver mutations (including but not limited to: EGFR sensitive mutations, ALK gene rearrangements, ROS1 mutations, BRAF 600E mutations, KRAS mutations);
Previously received 4~6 cycles of first-line induction therapy with PD-(L)1 combined with pemetrexed and platinum (cycles not combined with chemotherapy are not counted as combined treatment cycles), and imaging assessment shows non-progressive disease (i.e., CR, PR, or SD per RECIST 1.1).
Histologically/cytologically confirmed locally advanced unresectable or metastatic (unresectable Stage III or Stage IV per AJCC 8th Edition) colorectal adenocarcinoma;
Prior treatment with other cellular therapy products (DC, CIK, T cells, NK cells, CAR-T, etc.) except this product
Other malignancies within 5 years before screening (completely resolved carcinoma in situ and slowly progressing malignancies as determined by investigator excluded)
Symptomatic moderate to severe third-space effusion requiring therapeutic drainage
Gastrointestinal perforation, fistula, or intra-abdominal abscess within 6 months
Single group
NK Cells
Biological/VaccineAdministered according to standard clinical practice and product labeling
NK cells + PD-(L)1 inhibitor + pemetrexed as first-line maintenance therapy
Biological/Vaccine3-week cycles
NK cells + cetuximab/bevacizumab + capecitabine as first-line maintenance therapy
Biological/Vaccine2-week cycles
NK cells + PD-(L)1 inhibitor + VEGF inhibitor as first-line maintenance therapy
Biological/Vaccine3-week cycles
NK cells + PD-(L)1 inhibitor + capecitabine or S-1 as first-line maintenance therapy
Biological/Vaccine2-week cycles
Dose-Limiting Toxicity (DLT)
Incidence of DLT defined as: Grade 4-5 CRS or ICANS related to NK cells; Grade 3 CRS/ICANS not resolving to ≤Grade 2 within 7 days; Grade ≥3 non-hematologic toxicity not resolving to Grade 2 or baseline; Grade 4 hematologic toxicity not resolving to Grade 2 or baseline within DLT observation period
Adverse Events (AE)
Incidence and severity of treatment-emergent adverse events assessed by NCI-CTCAE v5.0
Progression-Free Survival (PFS)
Progression-Free Survival (PFS)
Objective Response Rate (ORR)
Proportion of patients achieving complete response (CR) or partial response (PR) per RECIST 1.1
Duration of Response (DOR)
From date of first documented response (CR or PR) until date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Disease Control Rate (DCR)
Proportion of patients with CR, PR, or stable disease (SD)
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