eligibility_summary
Adults 18–70 with unresectable BCLC B/C HCC (CSCO 2024), GPC3+ (IHC ≥2+), prior ≥1 systemic line incl PD‑1/L1 and/or TKI, Child‑Pugh A or B7 without encephalopathy, ECOG 0–1, ≥12‑week survival, measurable disease (RECIST/mRECIST), tumor tissue available, adequate organ function, contraception. Exclude: CNS mets, transplant, active infections, HLA Ab+, prior cell/GPC3 Tx, recent Tx/vaccine/surgery, unresolved AEs, immunosuppression, autoimmune/ILD, uncontrolled effusions, significant CV/VTE, heavy liver burden/major vessel thrombus, other trials, pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: SN301A, an off-the-shelf allogeneic CAR NK cell therapy armed with calibrated-release IL‑15 (crIL‑15). Mechanism: The CAR targets glypican‑3 (GPC3) on hepatocellular carcinoma cells, activating NK-mediated cytotoxicity (perforin/granzyme) and cytokine release, crIL‑15 sustains NK survival, proliferation, and persistence. Dosing: IV on Days 0/7/14 of 28‑day cycles (up to 3), dose-escalation 0.5–2×10^9 CAR+ NK cells. Preconditioning: fludarabine (purine analog) and cyclophosphamide (alkylating agent) for lymphodepletion to enhance NK engraftment/expansion. Targets/pathways: GPC3-expressing tumor cells, NK activation via CAR signaling, IL‑15/STAT5 survival signaling, reduction of host lymphocytes/Tregs via lymphodepletion. Population: advanced GPC3‑positive HCC.