eligibility_summary
Adults 18–70 with refractory recurrent/metastatic GI cancers (esophageal, gastric, pancreatic, colorectal), ECOG 0–1, ≥3‑mo survival, target‑protein positive on recent pathology, measurable disease, feasible apheresis/venous access, adequate labs (marrow/liver/renal/coag), prior ≥2nd‑line failure, residual AEs ≤G1, contraception/negative pregnancy test. Exclude active CNS mets, HIV/HBV/HCV, severe autoimmune/infection/cardiac/organ dysfunction, recent surgery/therapy/steroids, prior CAR‑T/TCR‑T, other malignancy, anticoagulation, pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Trial NCT06104241 tests BGT007 Injection, an investigational biological cell therapy (apheresis-derived therapeutic immune cells) given as a single IV infusion with dose-escalation (5.0×10^7 to 3.0×10^9 cells). Mechanism of action: adoptive cellular immunotherapy—infused tumor-targeted immune effector cells are intended to recognize a tumor-associated protein (patients must be “target protein” positive) and kill cancer cells via antigen recognition and immune cytotoxicity. Targeted cells/pathways: malignant cells in refractory/recurrent/metastatic digestive tract cancers (esophageal, gastric, pancreatic, colorectal) that express the unspecified target protein, engages immune effector pathways consistent with T/NK cell–mediated cytotoxic killing. Primary aim: assess safety and preliminary efficacy in an open-label, modified 3+3 dose-escalation design.