eligibility_summary
Adults 18–75 with HCC, ECOG ≤1, life expectancy ≥12 wks, progressed after ≥1 systemic therapy, not candidates for curative/local tx, GPC3 IHC ++/+++, measurable disease, BCLC B/C, Child‑Pugh ≤7, manageable lung mets, adequate organs/venous access, no active HBV, prior tx AEs ≤1, contraception and negative β‑hCG. Exclude cholangiocarcinoma, active brain mets, lesion ≥15 cm, recent cancers, autoimmune on immunosuppression, prior TCR/CAR‑T/CGT, active HCV/HIV/syphilis, transplant, infection, severe CV/CNS or encephalopathy, recent bleeding/ulcer, pregnancy, long‑term anticoagulation, unmet washout, noncompliance, allergy to JWATM214.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: JWATM214, an autologous “armored” GPC3-directed CAR-T cell therapy (biologic, genetically modified T cells). Patients undergo leukapheresis, lymphodepletion with cyclophosphamide (alkylating agent) and fludarabine (purine analog/antimetabolite), then a single IV infusion of CAR-T cells (dose-escalation). Mechanism of action: CAR-T cells express a chimeric antigen receptor that binds glypican‑3 (GPC3) on HCC cells, triggering T-cell activation (CD3ζ/co-stimulation), cytokine release, and targeted cytotoxic killing, “armored” design aims to enhance function/persistence in the tumor microenvironment. Targets: GPC3-positive hepatocellular carcinoma cells, pathways include GPC3 surface antigen recognition and downstream CAR signaling, lymphodepletion reduces host lymphocytes to improve CAR-T expansion.