eligibility_summary
Eligible: HCC confirmed, unresectable/relapsed after surgery/locoregional therapy, failed ≥1 systemic therapy, ECOG 0–1, HBsAg+, Child‑Pugh A (5–7), life expectancy ≥1 yr, HLA‑A02:01 or A24:02. Exclude: brain mets, active second cancer (except in‑situ cervix, non‑melanoma skin, localized prostate, DCIS, stage I uterine, superficial bladder), concurrent anti‑tumor therapy, recent investigational product/device (<28 d), HBV DNA ≥200 IU/mL, HBsAg ≥10,000 IU/mL, pregnant/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Intervention: LioCyx-M, an autologous, mRNA-engineered TCR-T cell therapy. Patient T cells are transiently redirected to express HBV antigen–specific T-cell receptors and are infused IV weekly (5–10×10^6 cells/kg). Mechanism of action: Engineered TCRs recognize HBV-derived peptides presented by HLA-A02:01 or HLA-A24:02 on tumor cells, triggering TCR/MHC class I–dependent activation and cytotoxic killing of HBV-related HCC. Targets: HBV antigen–expressing hepatocellular carcinoma cells, HLA class I antigen presentation pathway, CD8+ T-cell effector function. Design: Phase 1, open-label, single-arm safety/efficacy study in HBV+ HCC after standard therapy failure.