eligibility_summary
Eligible: CD19+ B‑ALL after allo‑SCT—first SCT with new/persistent MRD, SCT without prior remission (MRD ≥10−4), or ≥2nd SCT. Contraception: FCBP 2 methods + testing, no breastfeeding, males condoms, no sperm donation, all during and 3 mo after. Exclude: frank relapse (>5%), Ph+ ALL, EF<25%, cystatin‑C clearance<40, liver dysfunction, HIV/active hepatitis, GvHD III–IV/extensive chronic, recent high‑dose steroids/cytostatics, major neuro/psych, autoimmune cytopenias, pregnancy/lactation, hypersensitivity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05366218 tests tafasitamab (MOR00208), an Fc‑engineered humanized IgG1 anti‑CD19 monoclonal antibody (biologic immunotherapy), as IV monotherapy with loading/bi‑weekly dosing in pediatric post‑transplant high‑risk B‑lineage ALL. Mechanism: binds CD19 on B cells/leukemic blasts, enhancing Fcγ receptor–mediated antibody‑dependent cellular cytotoxicity (ADCC) and phagocytosis (ADCP) via NK cells and macrophages, and can induce direct apoptosis, leading to depletion of CD19+ cells. Targets: CD19+ B‑lineage ALL blasts (including minimal residual disease) and the B‑cell compartment, engages innate effector pathways (FcγRIIIa‑driven ADCC/ADCP). Study goals: Part I defines pediatric dose/safety, Part II assesses time to hematologic relapse or MRD increase as relapse prophylaxis/treatment of low MRD after SCT.