eligibility_summary
Eligible: chronic HBV (HBsAg ≥6 mo), HBeAg±, HLA-A02:01, A11:01, or A24:02, recent (≤6 mo) biopsy/Fibroscan showing CHB without bridging fibrosis or cirrhosis. Exclude: other chronic liver diseases, decompensated liver (Child-Pugh B/C, ascites, varices), HIV+, hepatocellular carcinoma, or AFP >20 ng/mL unless imaging rules out HCC.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Interventions: LioCyx-M (autologous mRNA-engineered TCR-T cell therapy) given with continued nucleos(t)ide analogues (NAs, oral small‑molecule antivirals). Mechanisms: LioCyx-M consists of patient T cells transfected with mRNA encoding HBV-specific T-cell receptors, infused cells recognize HBV peptides presented by HLA-A02:01/A11:01/A24:02 on infected hepatocytes and execute MHC class I–restricted cytotoxicity, aiming to clear HBV-infected cells and lower antigen burden. NAs inhibit HBV polymerase/reverse transcriptase, blocking viral DNA synthesis and reducing viremia. Targets/pathways: HBV-infected hepatocytes, TCR/MHC-I antigen recognition and CD8+ T-cell cytotoxic pathways, suppression of HBV replication via polymerase inhibition, with potential indirect impact on cccDNA by eliminating infected cells. Dosing: 5×10^5–50×10^6 cells/kg every 2 weeks.