eligibility_summary
Adults (≥18) with CD20+ WM/LPL, IgM >2×ULN, meeting IWWM2 treatment criteria, ≥1 prior line incl. anti‑CD20 and a BTKi (with washouts). ECOG ≤2, >2‑yr life expectancy, adequate marrow/organ function, no active HBV/HCV, controlled HIV allowed. Exclude transformed disease, uncontrolled hyperviscosity (plasmapheresis if IgM >4000), other trials, unresolved ≥G2 AEs, uncontrolled infection/cardiac/neuro/CNS WM, O2 need, recent immunosuppression/live vaccine, pregnancy/breastfeeding, epcoritamab allergy, contraception required.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Epcoritamab (GEN3013, DuoBody-CD3xCD20), a subcutaneous bispecific monoclonal antibody (T‑cell engager). Mechanism of action: simultaneously binds CD3 on T cells and CD20 on B cells, creating an immune synapse that activates cytotoxic T cells to kill malignant B cells (perforin/granzyme-mediated lysis), independent of native MHC. Targets: CD20-expressing lymphoplasmacytic/WM cells and CD3 on T cells, engages TCR/CD3 signaling to redirect T-cell cytotoxicity against B cells. Context: Phase 2, single-arm trial in previously treated Waldenström macroglobulinemia patients who have received prior anti‑CD20 antibody and a BTK inhibitor.