eligibility_summary
Eligible: CCHMC allogeneic HCT for non-malignant disease using alemtuzumab, first 7 need 10/10 HLA match or CD34+ product, thereafter any donor per review. Exclude: alemtuzumab anaphylaxis or uncleared prior exposure, life expectancy <4 wks, dialysis/plasmapheresis, no consent, unsafe specimen collection, unable to take SC dosing, cancer, PK modeling barriers (e.g., active HLH), or assay interference.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05501756 evaluates precision dosing of alemtuzumab (Campath), a recombinant humanized anti‑CD52 monoclonal antibody (biologic immunosuppressant) given subcutaneously as part of conditioning for allogeneic HCT in non‑malignant diseases. Alemtuzumab binds CD52 on mature lymphocytes and other immune cells, depleting them via complement and ADCC to blunt donor–recipient alloreactivity. Dosing is adjusted to reach a Day 0 serum level of 0.15–0.9 µg/mL to balance risks: low levels raise acute GVHD (insufficient T‑cell depletion), high levels increase mixed chimerism and delay immune reconstitution. Targets: CD52+ T and B cells (also some NK cells, monocytes, dendritic cells), pathways of alloimmune activation, GVHD, and immune recovery post‑transplant.