eligibility_summary
Eligible: moderate/severe hemophilia A, age 14-66, inhibitor positive at 2 visits, inhibitor titer >10 BU at screening. Exclude: contraindication to study drug or hamster protein allergy, other immune diseases or using immunosuppressants for another condition, prior failure of systemic ITI, poor compliance, or any investigator-judged unsuitability.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial tests immune tolerance induction (ITI) with SCT800 (recombinant factor VIII, protein replacement therapy) alone vs SCT800 plus daratumumab (anti-CD38 monoclonal antibody, IgG1). SCT800 provides FVIII antigen exposure to induce antigen-specific tolerance, aiming to eliminate FVIII inhibitors via modulation of adaptive immunity (reduced anti-FVIII B-cell responses, potential Treg-mediated tolerance). Daratumumab targets CD38 on antibody-secreting cells, depleting plasmablasts/long‑lived plasma cells that produce anti-FVIII alloantibodies, it also impacts CD38+ immune subsets (e.g., some B/T/NK cells). Targeted pathways: humoral immunity and plasma-cell–mediated inhibitor production.