eligibility_summary
Eligible: 18–65 with serum DSA MFI≥2000, scheduled for allo‑HSCT, survival >3 mo, ECOG 0–2, normal kidneys (BUN/Cr ≤1.5×ULN, Ccr>80), liver (ALT/AST ≤1.5×ULN, TBiL ≤1.5×ULN), ECG free of AMI/arrhythmia/AV block, LVEF≥50% with normal MYO/BNP, no active RHD or cardiomegaly, lung function FEV1/FVC/DLCO ≥60% predicted. Exclude: severe blood‑product allergy, active infection/rheumatism, secondary Ig deficiency, serious organ failure (respiratory, heart, decomp liver, renal), no consent.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06177561 tests an LPE-based desensitization to clear donor‑specific anti‑HLA antibodies (DSA) before allo‑HSCT. Interventions: • Lymphoplasma exchange (procedure, 20–30 mL/kg ×2) apheretically removes plasma (DSA) and circulating lymphocytes to acutely reduce antibody load. • Anti‑CD20 monoclonal antibody (biologic mAb, 375 mg/m2 ×2) depletes CD20+ B cells via ADCC/CDC/apoptosis, limiting new DSA production. • Intravenous immunoglobulin (IVIG, biologic polyclonal IgG, 0.4 g/kg/day ×5) neutralizes pathogenic antibodies, blocks Fcγ receptors and complement, and accelerates IgG catabolism. Targets/pathways: circulating anti‑HLA class I/II antibodies, CD20+ B cells, humoral alloimmunity and complement-mediated graft injury. Compared with historical therapeutic plasma exchange. Condition: DSA‑positive allo‑HSCT candidates.