eligibility_summary
Adults 18–75 with metastatic CRC refractory/intolerant to ≥2nd‑line CSCO therapy, RECIST‑measurable, GUCY2C IHC+ (recent tissue), ECOG 0–1, life expectancy >3 mo, adequate organs, LVEF ≥50%, O2 sat >92%, vascular access, contraception. Excludes brain mets, transplants, unresolved toxicities, COPD/ILD, CNS/cardiac disease, autoimmune on immunosuppression, active HBV/HCV/HIV/EBV/CMV, recent chemo/steroids/procedures, prior cell/anti‑GUCY2C, anticoagulants/antiplatelets, bleed/obstruction risk, other cancers, concurrent trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I, single-arm study testing IM96 CAR‑T cells in advanced colorectal cancer. Intervention: IM96 CAR‑T (autologous, genetically engineered chimeric antigen receptor T cells) given as a single infusion after lymphodepletion. Mechanism: CAR‑T specifically binds GUCY2C (guanylyl cyclase C) on tumor cells, activating T‑cell cytotoxicity and cytokine release to kill GUCY2C‑positive cancer cells (HLA‑independent). Lymphodepletion drugs: fludarabine (antimetabolite, purine analog causing lymphocyte depletion) and cyclophosphamide (alkylating agent causing DNA crosslinking and immunodepletion) to enhance CAR‑T expansion and persistence. Dose escalation (modified 3+3): 12×10^8 or 20×10^8 cells. Targets: GUCY2C‑expressing colorectal tumor cells, activation of T‑cell effector pathways via CAR signaling, preconditioning suppresses host lymphocytes/Tregs to facilitate CAR‑T activity.