eligibility_summary
Inclusion: 18–70, refractory/relapsed CDH17+ solid tumor with measurable disease (RECIST v1.1), ECOG 0–1, life ≥3 mo, adequate organs, contraception/negative pregnancy test, consent. Exclusion: recent anticancer/biologic/steroid therapy, live vaccine/trial, pregnancy/lactation, active HBV/HCV/HIV/syphilis, unresolved ≥G2 AEs, prior transplant or anti‑CDH17 CAR‑T, major surgery (recent/planned), CNS mets unless asymptomatic and steroid‑free, serious comorbidities, drug hypersensitivity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Anti-CDH17 CAR-T cells—autologous, gene‑modified T‑cell therapy infused IV after lymphodepleting chemotherapy (fludarabine + cyclophosphamide). Mechanism of action: Patient T cells are engineered with a chimeric antigen receptor to bind cadherin‑17 (CDH17) on tumor cells, triggering T‑cell activation, cytokine release, and targeted cytolysis of CDH17‑positive solid tumors. Lymphodepletion with fludarabine (purine analog) and cyclophosphamide (alkylating agent) reduces host lymphocytes to enhance CAR‑T engraftment/expansion. Cells/pathways targeted: CDH17‑expressing epithelial tumor cells (notably in colorectal, gastric, pancreatic, and biliary cancers), engineered T cells mediate immune killing. Conditioning chemotherapy targets proliferating lymphocytes/DNA synthesis pathways. Study: Phase 1, single-arm, dose escalation (accelerated titration/3+3) then expansion to define MTD/RP2D and assess safety/early efficacy.