Allogeneic NK Cell Therapy Combined With Standard Maintenance Treatment in Advanced Solid Tumors (NCT07551778) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Allogeneic NK Cell Therapy Combined With Standard Maintenance Treatment in Advanced Solid Tumors
20 participantsStarted 2026-05
Plain-language summary
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).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age 18-75 years, either gender
✓. Cohort 1 \& 3: Histologically or cytologically confirmed locally advanced unresectable or metastatic non-squamous NSCLC (Stage IIIB-IV) without known actionable driver gene mutations (including but not limited to: EGFR sensitizing mutations, ALK rearrangement, ROS1 rearrangement, BRAF V600E mutation, KRAS mutation)
✓. Cohort 1 \& 3: Previously received 4-6 cycles of first-line induction therapy with PD-(L)1 inhibitor combined with pemetrexed plus platinum, with radiographic assessment of non-progressive disease (CR, PR, or SD per RECIST 1.1)
✓. Cohort 2: Histologically or cytologically confirmed locally advanced unresectable or metastatic colorectal adenocarcinoma (unresectable Stage III or Stage IV per AJCC 8th edition)
✓. Cohort 2: Previously received 6-9 cycles of first-line induction therapy with cetuximab or bevacizumab combined with FOLFOX or FOLFIRI, with radiographic assessment of non-progressive disease (CR, PR, or SD per RECIST 1.1)
✓. Prior neoadjuvant/adjuvant chemotherapy allowed if disease recurrence or metastasis occurred \>6 months after last chemotherapy dose
✓. At least one measurable lesion per RECIST 1.1 (except patients who achieved CR during induction therapy): non-lymph node lesion ≥1.0 cm in longest diameter, or lymph node lesion ≥1.5 cm in short diameter; lesions treated with local therapy (radiation or interventional) cannot be target lesions unless progression is documented
What they're measuring
1
Dose-Limiting Toxicity (DLT)
Timeframe: During the first treatment cycle (21 days for Cohorts 1&3, 14 days for Cohort 2)
2
Adverse Events (AE)
Timeframe: From first dose through 30 days after last dose
✕. 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
✕. Significant cardiovascular disease history including
✕. Arterial or venous thrombotic events within 6 months before enrollment (CVA, DVT, PE, etc.)
✕. Active infection (viral, bacterial, fungal) currently being treated, or any infection requiring IV antibiotics for ≥7 days within past 6 weeks, or oral antibiotics within past 1 week
✕. Active autoimmune disease or history of severe autoimmune disease requiring long-term immunosuppression