eligibility_summary
Eligible: >=18, meet institutional criteria for RIC alloHSCT with peripheral blood donor (matched related, haplo, MUD, MMUD), adequate organ function (ANC>=500, Plt>=10k, bili<=3, AST/ALT<5xULN, Cr<=2, LVEF>=35, FEV1>=50), high DSA allowed, no suitable alternative donor, faculty-approved, willing. Exclude: prior anti-CD38, recent investigational drug/RT, COPD FEV1<50, moderate/severe or uncontrolled asthma, hypersensitivity, myeloma/AL, planned myeloablative/BM or cord, HIV, active HBV or HCV (unless SVR), major cardiac disease/arrhythmia.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Early Phase 1, single-arm pilot in alloHSCT candidates with high donor-specific anti‑HLA antibodies (DSA). Drug/intervention: Darzalex Faspro (daratumumab + hyaluronidase‑fihj). Daratumumab is a subcutaneous anti‑CD38 monoclonal antibody that depletes CD38+ plasma cells, lowering immunoglobulins/DSA (via immune effector mechanisms). Hyaluronidase‑fihj is an enzyme that enhances subcutaneous dispersion/absorption. Regimen: 4 weekly SC doses before standard desensitization (therapeutic plasma exchange, IVIG, immunosuppression) and transplant. Device: JH‑DSA Semi‑Quant Screen/Response Score, a serum algorithm combining flow crossmatch and solid‑phase immunoassays to quantify/monitor DSA. Target cells/pathways: long‑lived CD38+ plasma cells and humoral anti‑HLA antibody production (CD38 pathway) to reduce DSA‑mediated graft rejection risk.