eligibility_summary
Adults 18–70 providing consent with histologically confirmed metastatic colorectal or advanced GI cancers (esophageal, gastric, pancreatic, small bowel), GCC IHC+, ≥1 measurable lesion per RECIST v1.1, ECOG 0–1, expected survival ≥3 months, adequate labs. Excludes prior CAR‑T/TCR‑T/tumor vaccine ≤6 months (detectable cells), prior anti‑GCC, inadequate washout, brain mets, pregnancy/lactation, HCV/HIV/syphilis/EBV, severe comorbidities, or other investigator‑judged risks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase 1, single-arm dose escalation/expansion of LCAR-G08 in advanced GCC-positive GI tumors. Intervention: LCAR-G08, a biological cell therapy (CAR-T). Mechanism: patient T cells are engineered with a chimeric antigen receptor that specifically binds guanylyl cyclase C (GCC) on tumor cells, CAR signaling activates T-cell cytotoxicity and cytokine release to kill GCC-expressing cancer cells and drive T-cell expansion. Pretreatment: lymphodepleting chemotherapy with cyclophosphamide (alkylating agent causing DNA crosslinks) and fludarabine (purine analog inhibiting DNA synthesis) to reduce host lymphocytes and enhance CAR-T engraftment. Targets: tumor cells expressing GCC (a receptor guanylyl cyclase on intestinal epithelium/tumors), immune effector pathway is T-cell activation via CAR signaling. Outcome focus: safety, tolerability, PK, and preliminary anti-tumor activity. Location: China.