eligibility_summary
Eligible: 14–60 yrs undergoing allo-HSCT, ECOG ≤2, positive PRA within 1 month (HLA class I/II Ab MFI ≥5000), no severe organ failure or active infection, consent to anti-HLA testing/desensitization. Exclude: severe organ disease, pregnancy, refusal of desensitization, life-threatening conditions, substance use/uncontrolled psych/cognitive issues, other trials <3 months, poor adherence or otherwise unsuitable per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single-arm desensitization study in allo-HSCT candidates with high anti-HLA antibody titers (MFI ≥5000). Interventions: (1) Immunoadsorption or plasma exchange (therapeutic apheresis) to physically remove circulating anti-HLA IgG, (2) Rituximab, a chimeric anti-CD20 monoclonal antibody, to deplete CD20+ B cells and reduce new antibody formation, (3) High-dose IVIG (pooled human IgG) to neutralize pathogenic antibodies, provide anti-idiotype effects, block Fcγ receptors and FcRn to enhance IgG catabolism, and inhibit classical complement activation. Targets/pathways: humoral immunity—CD20+ B cells (including memory B cells), circulating donor-specific anti-HLA antibodies, Fcγ/FcRn pathways, and complement—aimed at lowering antibody titers and reducing antibody-mediated graft failure risk before transplant.