Zanubrutinib + Tafasitamab

Participants will be administered Zanubrutinib orally (PO) via capsules daily during each 28-day cycle at the following dose levels: * Phase 1 Dose Level 1: 320 mg * Phase 1 Dose Level -1: 240 mg * Phase 2: Recommended dose determined in Phase 1.

Participants will be administered a 12 mg/kg dose of Tafasitamab intravenously (IV) during each 28-day cycle as follows: * Early Induction - Cycle 1: Days 1, 4, 8, 15, and 22 * Early Induction - Cycles 2 and 3: Days 1, 8, 15 and 22 * Late Induction - Cycles 4 through 12: Days 1 and 15

The main purpose of this study to find the ideal dose for the combination treatment of Zanubrutinib and Tafasitamab in patients with mantle cell lymphoma. Another purpose is to assess how well the combination treatment works in patients with the study disease.

Registro actualizado en ClinicalTrials.gov →

• Men and women ≥ 18 years of age
• Patients must have histologic confirmation of mantle cell lymphoma (MCL) defined by the World Health Organization (WHO) classification
• Baseline PET/CT scans must demonstrate fluorodeoxyglucose (FDG) avid lesions compatible with CT defined anatomical tumor sites. Patients should have at least one measurable site of disease per Lugano classification
• Patient should have indication according to primary investigator for treatment initiation
• Estado funcional del Eastern Cooperative Oncology Group (ECOG) ≤ 2
• Life expectancy of greater than 4 months.

Criterios de inclusión tal como figuran en el registro, recortados. La lista completa, con las exclusiones, está en el registro actualizado.