eligibility_summary
Eligibility: AA ≥12 yrs, ECOG ≤2, platelet transfusion–dependent (PLT<10×10^9/L or <20 with bleeding) with refractoriness (CCI<7500 at 60 min or <4500 at 24 h), consent. Exclude: inherited BMF, PNH, recent chemo/radiation, other causes of cytopenia, active infections (HIV/HBV/HCV), major bleeding, significant liver/renal/heart disease, uncontrolled DM, pregnancy, psych/CVA hx, recent trials, allergy/prior daratumumab, recent ATG/ALG or anti‑CD20, TPO‑RA without 4‑wk washout, per PI discretion.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase 1, single-arm, open-label study in aplastic anemia with platelet transfusion refractoriness. Intervention: Daratumumab—human IgG1 monoclonal antibody (immunotherapy) targeting CD38. Mechanism of action: binds CD38 and depletes CD38+ immune cells via ADCC/CDC/ADCP and apoptosis, eliminates antigen-presenting cells (dendritic cells, macrophages) and depletes plasma cells, as well as CD38+ B and T lymphocytes, thereby reducing auto/alloantibody production implicated in platelet transfusion refractoriness. Cells/pathways targeted: CD38-expressing plasma cells (antibody production), B cells, T cells, dendritic cells, macrophages, pathways of antigen presentation and humoral immunity to platelet/HLA antigens. Goal: improve post-transfusion platelet increments.