eligibility_summary
Adults 18–70 with CLDN18.2‑positive locally advanced/metastatic digestive tumors (e.g., gastric/EGJ, pancreatic) after SOC failure, measurable/evaluable disease, ECOG 0–1, survival ≥12 wks, adequate organs, AEs recovered, consent/contraception. Exclude: pregnancy, HIV/HBV/HCV/syphilis/CMV/EBV, uncontrolled infection/effusions, extensive lung/liver mets, SpO2≤95%, major pulmonary/cardiac/CNS/autoimmune/coagulopathy, uncontrolled HTN/DM, steroids/immunosuppression, other malignancy, prior CAR‑T/TCR‑T, recent trials/therapy, severe allergy/mental illness, any unsafe condition.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05946226 (Phase I). Intervention: IMC002, an autologous, gene‑modified CAR‑T cell therapy (single infusion, 1×10^8–5×10^8 cells). Mechanism: Patient T cells engineered to express a chimeric antigen receptor targeting Claudin 18.2 (CLDN18.2), a tight‑junction protein on digestive system tumors, CAR engagement activates T‑cell cytotoxicity and cytokine release to kill CLDN18.2+ cancer cells. Conditioning: Lymphodepleting chemotherapy with cyclophosphamide (alkylator), fludarabine (purine analog), and nab‑paclitaxel (microtubule stabilizer) to reduce endogenous lymphocytes and enhance CAR‑T expansion. Targets: CLDN18.2‑expressing tumor cells (e.g., gastric/GEJ adenocarcinoma, pancreatic cancer), immune compartment modulation via lymphodepletion, effector cells are autologous CAR‑T lymphocytes acting through TCR‑independent CAR signaling pathways. Purpose: assess safety, feasibility, and preliminary efficacy.