eligibility_summary
Peds/AYA 1–21y with GPC3+ solid tumors by IHC (≥25%, intensity ≥2). K/L ≥60%, LE ≥16w (proc). HCC: BCLC A–C, CPT<7, INR≤1.7. Adequate organs: CrCl≥60, bili<3×ULN, ANC>750, Plt>75k, Hgb≥8, O2≥92%. Incurable/relapsed, washout, contraception. Exclude: pregnancy/lactation, active infection (HBV/HCV exceptions), HIV+, major cardiac dz, autoimmune, systemic steroids, live vaccines, organ transplant, murine hypersensitivity/HAMA.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: CARE T cells (autologous, retrovirally transduced GPC3-specific CAR-T cells armored with IL-15 and IL-21, plus an inducible caspase-9 safety switch activatable by AP1903) and lymphodepleting chemotherapy (cyclophosphamide, fludarabine). Mechanisms: GPC3 CAR engagement activates T-cell cytotoxicity, IL-15/IL-21 provide autocrine common gamma-chain cytokine signaling to boost proliferation, survival, persistence, and anti-tumor function, iCasp9 allows rapid apoptosis of CAR-T cells if toxicity occurs, lymphodepletion reduces endogenous lymphocytes to aid CAR-T expansion. Targets: glypican-3–expressing tumor cells (pediatric liver and other GPC3+ solid tumors). Pathways: CAR/TCR signaling, IL-15/IL-21 cytokine pathways, caspase-9 apoptosis. Drug types: gene-modified cellular therapy, alkylating agent (cyclophosphamide), purine analog (fludarabine), small-molecule dimerizer (AP1903).