NCT lookup

Inclusion Criteria:

1. Age 18-75 years, either gender
2. 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)
3. 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)
4. Cohort 2: Histologically or cytologically confirmed locally advanced unresectable or metastatic colorectal adenocarcinoma (unresectable Stage III or Stage IV per AJCC 8th edition)
5. 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)
6. Prior neoadjuvant/adjuvant chemotherapy allowed if disease recurrence or metastasis occurred \>6 months after last chemotherapy dose
7. 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
8. Adequate bone marrow and organ function:

   1. ANC ≥1.5×10⁹/L; Platelet \>90×10⁹/L; Hemoglobin \>9 g/dL
   2. Liver function: Total bilirubin \<1.5×ULN; ALT and AST \<3×ULN (\<5×ULN if liver metastases present)
   3. Renal function: Serum creatinine ≤1.5×ULN
   4. Coagulation: PT, APTT, INR \<1.5×ULN
9. ECOG performance status 0-1
10. Life expectancy ≥3 months
11. Non-pregnant, non-lactating; women of childbearing potential must have negative serum pregnancy test within 7 days before cell infusion and agree to use reliable contraception during study and for 6 months after last infusion; men with partners of childbearing potential must agree to use reliable contraception
12. Voluntary informed consent and able to comply with follow-up

Exclusion Criteria:

1. Prior treatment with other cellular therapy products (DC, CIK, T cells, NK cells, CAR-T, etc.) except this product
2. Other malignancies within 5 years before screening (completely resolved carcinoma in situ and slowly progressing malignancies as determined by investigator excluded)
3. Symptomatic moderate to severe third-space effusion requiring therapeutic drainage
4. Gastrointestinal perforation, fistula, or intra-abdominal abscess within 6 months
5. Significant cardiovascular disease history including
6. Arterial or venous thrombotic events within 6 months before enrollment (CVA, DVT, PE, etc.)
7. 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
8. Active autoimmune disease or history of severe autoimmune disease requiring long-term immunosuppression
9. Participation in other interventional clinical trials within 3 months
10. Toxicities from prior interventions not resolved to Grade ≤2 (alopecia excluded)
11. Untreated chronic active hepatitis B, chronic HBV carriers with HBV DNA ≥1000 copies/mL; HCV antibody positive with HCV-RNA positive; HIV antibody positive; syphilis antibody positive
12. Any other condition deemed by investigator to make subject unsuitable for study participation