eligibility_summary
Key eligibility: Adults (≥18) ≥45 days post-allo-HCT, disease in remission with neutrophil/platelet engraftment, immune cytopenia (AIHA/ITP/PRCA) per criteria, refractory/dependent after steroids ± IVIG/rituximab, ANC ≥1.0×10^9/L, no active hepatitis, contraception and consent required. Exclude: relapse, TA-TMA, uncontrolled GVHD/organ failure/infection, pregnancy, HIV/active HBV/HCV, hypersensitivity to anti-CD38/components, recent investigational drug, inability to comply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Open-label, single-arm Phase II trial in adults with refractory immune cytopenias (AIHA, ITP, PRCA) after allo-HCT testing isatuximab. Intervention: Isatuximab, an intravenous biological agent (IgG1 monoclonal antibody) targeting CD38. Mechanisms of action: binds CD38 and depletes CD38+ cells via antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and antibody-dependent cellular phagocytosis (ADCP), can induce direct apoptosis, inhibits CD38 ectoenzyme (NADase/cyclase) activity, reducing adenosine production and modulating immune signaling. Cells/pathways targeted: CD38-expressing plasmablasts/plasma cells producing pathogenic autoantibodies, with effects on other CD38+ immune subsets, Fcγ receptor and complement effector pathways, CD38–NAD+/adenosine axis.