eligibility_summary
Eligibility: Adults (≥18) with AIH and/or PSC, EBV-seropositive within 12 months, listed for liver transplant, able to consent. Exclusions: other major liver disease (viral hepatitis, alcohol-related, NASH), prior/multi-organ transplant, acute liver failure, malignancy, recent investigational drugs, pregnancy/no contraception, leukopenia/lymphopenia, HIV, recent HBV/HCV+, heavy alcohol or PETH>80, untreated latent TB, recent live vaccine. At LT: dialysis or eGFR<30, MELD-Na>30, donor DCD, HCV+, HBV+, or ABO-incompatible.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Siplizumab (biologic, anti-CD2 monoclonal antibody) given 0.6 mg/kg IV on transplant Day 0 and Day 4 as induction therapy in adults with autoimmune liver disease (AIH/PSC) undergoing liver transplant. Mechanism: binds CD2 on T cells (and NK cells), blocking CD2–CD58 costimulatory signaling and preferentially depleting/modulating memory T cells to reduce T cell–driven alloimmune and autoimmune activity after transplant. Targets: memory CD2+ T cells, T-cell activation/costimulation pathways (CD2/CD58), with potential impact on NK-cell function. Phase: Open-label, single-arm Phase 1 safety/PK/PD study.