eligibility_summary
Adults 18–70 with unresectable BCLC B/C HCC after ≥1 systemic therapy, Child‑Pugh ≤7, measurable intrahepatic lesion, ECOG 0–1, GPC3+, adequate organs, LE>12 wks, HBV DNA<2000 if HBV+. Exclude resectable or transplant candidates/waitlist, pregnancy/lactation, active infection or HIV/HCV, cytopenias, ascites needing intervention, ≥50% liver or main PV/mesenteric/IVC thrombus, encephalopathy/brain mets, recent steroids/therapy, prior GPC3, unresolved ≥G2 AEs, other recent cancer, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CBG166, an autologous, 4th‑generation anti‑GPC3 chimeric antigen receptor T‑cell (CAR‑T) therapy administered intravenously. Type: biological, adoptive cell therapy. Mechanism of action: patient T cells are engineered to express a CAR that recognizes glypican‑3 (GPC3), antigen binding activates CAR signaling, leading to T‑cell activation, proliferation, cytokine release, and perforin/granzyme‑mediated cytotoxic killing of tumor cells. Targets: GPC3 expressed on hepatocellular carcinoma cells (oncofetal heparan sulfate proteoglycan), enabling selective attack on GPC3‑positive HCC. Trial design: Phase 1, single‑arm, dose‑escalation in advanced/unresectable HCC, assessing safety (primary) and preliminary efficacy plus PK/PD (secondary).