eligibility_summary
Chronic HBV: HBsAg+, HBeAg−/anti‑HBe+ on nucleos(t)ide analogs >1 yr, adequate organs, recent liver assessment without bridging fibrosis/cirrhosis (e.g., FibroScan <9 kPa), off other immunomodulators, women of childbearing potential negative pregnancy test, consented. Exclude recent acute infection/GI bleed, decompensated/advanced cirrhosis, viral co-infections/other liver disease, HCC/AFP>20 (unless cleared), recent cell therapy, transplant, severe irAEs/allergy, recent IP, poor venous access.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Interventions: Autologous HBV-specific TCR-T cells (biologic, mRNA-engineered T-cell therapy) administered alongside ongoing nucleos(t)ide analogue (NUC) therapy (small-molecule antivirals such as entecavir/tenofovir). Mechanisms: Patient T cells are transfected with synthetic mRNA encoding an HBV antigen–specific T-cell receptor, driving transient TCR expression and redirecting cytotoxic CD8+ T-cell activity to HBV peptide–HLA complexes on infected hepatocytes, promoting targeted killing and antiviral immune restoration. NUCs inhibit HBV polymerase/reverse transcription to suppress viral DNA replication and reduce antigen burden. Targets: HBV antigens on hepatocytes (via HLA), CTL/TCR signaling and perforin–granzyme cytotoxic pathway, and the HBV polymerase pathway.