eligibility_summary
Adults 18–75 with HER2+ gastric cancer (IHC3+ or 2+/ISH+), confirmed peritoneal metastasis, measurable disease, ECOG 0–2, >12‑wk survival, prior ≥2nd‑line failure (chemo ± targeted allowed), ≥2 wks since last therapy, agree to IP dosing, contraception. Exclude other malignancies (except allowed), on immunosuppression, untreated/symptomatic CNS disease, LVEF<50%, cytopenias, organ dysfunction, obstruction, active HIV/HBV/HCV/TB/syphilis, pregnancy, uncontrolled illness, allergy, no venous access, concurrent trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Autologous HER2-targeted chimeric antigen receptor macrophages (CAR‑M), a gene‑modified cellular immunotherapy. Patient PBMCs are collected after G‑CSF mobilization, differentiated to macrophages, and transduced via an adenoviral vector to express an anti‑HER2 scFv CAR, cells are infused intraperitoneally in a 3+3 dose escalation (3×10^8 → 5×10^8 → 1×10^9 cells). Mechanism of action: CAR binding to HER2 on tumor cells activates macrophage phagocytosis and cytotoxicity and may remodel the tumor microenvironment to enhance anti‑tumor immunity. Targets: HER2-expressing gastric cancer cells within peritoneal metastases and macrophage innate effector pathways. Early Phase 1, single-arm.