eligibility_summary
Eligible: ≤18 yrs with ICC2022-defined EBV-T/NK LPD, planning allo-HSCT at this center, consented, and meeting donor/disease criteria (≥1 for haplotype-related donors, ≥2 for unrelated): donor age ≥40, donor is unrelated or haplotype-related female/collateral with ≥1 mismatch, CD3 dose ≥4×10^8/kg, HLH flare/active disease, ATG/ATLG/ALG <10 mg/kg. Exclude: expected survival ≤3 months from MOF, or no consent.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase 4, single-arm allo-HSCT protocol for EBV-T/NK LPD adding a recombinant humanized anti-CD25 monoclonal antibody. Drug/intervention: recombinant humanized anti-CD25 mAb (biologic, IL-2 receptor alpha antagonist). Mechanism: binds CD25 (IL-2Rα) on activated T cells (and some NK/Treg subsets), blocks IL-2 binding and downstream JAK/STAT5 signaling, inhibiting T-cell activation/proliferation and alloreactivity, may deplete CD25+ cells via Fc effector functions depending on isotype. Target cells/pathways: CD25+ activated donor T cells that drive GVHD, IL-2/IL-2R signaling axis, potentially CD25-expressing EBV-infected T/NK LPD cells. Goal: reduce acute/chronic GVHD and impact engraftment, TMA, early EBV reactivation, and relapse.