eligibility_summary
Eligibility: consent, GI tumors—gastric adenocarcinoma (CDH17+), colorectal adenocarcinoma, or well-diff mid/hindgut NETs (Ki67≤55%), tissue available, ≥1 prior systemic therapy, age 18–85, measurable disease (except phase 1 escalation), ECOG 0–1, ≥12-week life expectancy, protocol labs, LVEF≥50%, HIV/HBV/HCV negative, contraception. Exclude: prior CDH17 therapy, >G1 unresolved tox, CNS mets/seizures, severe GI autoimmunity, ≥50% liver burden, active infection, effusions/ILD/NYHA III–IV, high-dose steroids, recent malignancy, pregnancy/breastfeeding, other serious illness.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CHM-2101, an autologous cellular immunotherapy (CAR T cells). Patient T cells are lentivirally engineered ex vivo to express a chimeric antigen receptor targeting Cadherin 17 (CDH17), then expanded and infused IV once after lymphodepletion. Mechanism of action: CAR engagement of CDH17 on tumor cells triggers T‑cell activation, proliferation, cytokine release, and cytotoxic killing independent of native TCR, aiming to eliminate CDH17+ gastrointestinal malignancies. Conditioning: fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent) given pre-infusion for lymphodepletion to enhance CAR T expansion/persistence. Targets: CDH17-expressing tumor cells in gastric and colorectal adenocarcinoma and mid/hindgut neuroendocrine tumors, immune compartment modulation via depletion of host lymphocytes (including Tregs).