eligibility_summary
Adults ≥18 with WHO MCL, FDG‑avid measurable disease on PET/CT, treatment indicated, ECOG ≤2, life exp >4 mo, adequate organ/marrow, Phase 1: relapsed MCL after 1–3 lines (BTKi allowed), Phase 2: untreated symptomatic MCL unfit for intensive chemoimmunotherapy. Exclude CNS MCL, active infection (incl COVID), hepatitis PCR+ or HIV, cardiac/QTc abnormalities, recent anti‑cancer therapy/surgery, strong CYP3A meds, bleeding/stroke, pregnancy/breastfeeding, unresolved ≥G2 toxicity, impaired capacity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1/2 study in mantle cell lymphoma testing zanubrutinib plus tafasitamab, followed by zanubrutinib maintenance. Zanubrutinib: oral small-molecule, second-generation covalent Bruton tyrosine kinase (BTK) inhibitor, blocks B-cell receptor (BCR) signaling (BTK to NF-kB/PI3K-AKT/ERK), limiting proliferation, survival, and trafficking of malignant B cells. Tafasitamab: intravenous, Fc-engineered humanized anti-CD19 IgG1 monoclonal antibody, binds CD19 on B cells to trigger antibody-dependent cellular cytotoxicity and phagocytosis (via NK cells and macrophages) and direct apoptosis, depleting tumor B cells. Targets: CD19+ MCL B cells, BTK/BCR pathway, innate effector engagement. Goal: set RP2D and assess efficacy.