eligibility_summary
Adults (≥18) with CD19/CD20+ B‑cell PTLD after solid organ transplant, measurable disease, ECOG ≤3/KPS >30, expected survival >30 days, no prior PTLD therapy except RIS, steroids, antivirals, palliative RT, adequate ANC/platelets, renal (CrCl ≥30), hepatic (AST/ALT ≤3×ULN, bili ≤3×ULN), controlled HIV allowed, consent/contraception required. Exclude uncontrolled infection, CNS PTLD, severe cardiac illness, PML, active HBV viremia, pregnancy/breastfeeding, recent live vaccine/investigational drug, or unsafe conditions.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single-group trial testing tafasitamab plus rituximab as first-line therapy for B-cell PTLD after solid organ transplant. Drugs/mechanisms: Tafasitamab is an anti-CD19, humanized, Fc-engineered IgG1 monoclonal antibody that enhances antibody-dependent cellular cytotoxicity/phagocytosis (ADCC/ADCP) and induces apoptosis, depleting malignant/normal B cells. Rituximab is an anti-CD20, chimeric IgG1 monoclonal antibody that mediates ADCC/ADCP, complement-dependent cytotoxicity (CDC), and direct apoptosis, leading to B-cell depletion. Targets/pathways: CD19+ and CD20+ B cells (including EBV-driven PTLD clones), indirect suppression of B-cell receptor survival signaling, engagement of innate effector cells (NK cells, macrophages) via Fc-gamma receptors. Procedures include PET/CT, biopsy, and blood-based immune profiling. Primary endpoint: complete response after 4 weekly cycles. Status: recruiting.