NCT07551778
Allogeneic NK Cell Therapy Combined With Standard Maintenance Treatment in Advanced Solid Tumors
Not Yet Recruiting · Phase 1, Phase 2 · BOE Technology Group Co., Ltd. · registry updated 2026-08-26
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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).
Inclusion
- Age 18-75 years, either gender
- Subjects must meet one of the following conditions:
- Cohort 1, Cohort 3:
- 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;
Exclusion
- 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
- As assessed by the investigator, intrahepatic tumor mass occupies more than 50% of the entire liver, or tumor thrombus invades major blood vessels (such as the main portal vein, superior mesenteric vein, or inferior vena cava), leading to complications such as portal hypertension or related clinical risks.
- Significant cardiovascular disease history including