eligibility_summary
Adults 18–75 with advanced gastric/pancreatic cancer after failure/intolerance of standard therapy, CLDN18.2 IHC ≥10%, ≥1 measurable lesion (RECIST 1.1), ECOG 0–1, prior toxicities ≤G1, life expectancy ≥12 wks, adequate marrow/organ function and EF ≥50%, contraception (12 months) and negative pregnancy test. Exclude: other cancers, recent CLDN18.2 cell therapy, hypersensitivity, autoimmune disease, uncontrolled infection (HIV/HBV/HCV/syphilis), CNS mets, severe heart disease, GI bleeding/ulcers, pregnancy/lactation, or per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06464965 (Phase I, single-arm) testing CB CAR-NK182, a biological, cord blood–derived CAR-NK cell therapy targeting Claudin18.2 in advanced gastric and pancreatic cancer (CLDN18.2 IHC ≥10%). Dosing cohorts: 2, 4, or 8 ×10^6 cells/kg on days 0, 7, and 14. Mechanism: NK cells engineered with a chimeric antigen receptor recognizing Claudin18.2 bind tumor cells, triggering NK activation and cytotoxicity (perforin/granzyme release, cytokine secretion) and immune-mediated tumor killing, study also assesses in vivo expansion/persistence. Targets: Claudin18.2 (tight junction protein) on tumor cells, engages NK cell activation pathways and downstream apoptosis of Claudin18.2-positive gastric and pancreatic adenocarcinoma cells. Primary endpoints: MTD and DLT, secondary: ORR, DCR, PFS, OS, DOR.