Phase 12a Study of BI-1206 with Rituximab, With or Without Acalabrutinib, in Adults with Indolent B-Cell Non-Hodgkin Lymphoma That Has Returned or Is Resistant to Rituximab

What this Trial Is About

Researchers are studying BI-1206, a monoclonal antibody targeting CD32b, combined with rituximab with or without acalabrutinib, in adults with indolent B-cell Non-Hodgkin Lymphoma NHL that has relapsed or is resistant to rituximab treatment. The trial focuses on specific lymphoma subtypes including follicular lymphoma except grade 3B, marginal zone lymphoma, and mantle cell lymphoma. This Phase 12a trial aims to assess safety, dosing, and preliminary effectiveness. The study has two main parts Phase 1 involves dose escalation with intravenous IV and subcutaneous SC dosing of BI-1206 combined with rituximab to determine the best doses for Phase 2a. Phase 2a includes dose expansion with the selected IV dose, signal-seeking cohorts evaluating BI-1206 with rituximab and acalabrutinib via IV and SC routes, and a dose optimization phase to select the recommended BI-1206 dose in combination with both treatments. Participants will receive treatment during an induction period of 28 days, during which safety and dose-limiting toxicities are closely monitored. Researchers will evaluate adverse events, drug levels, immune responses, and lymphoma response rates up to one year. The study involves biopsies, blood tests, and clinical assessments to track treatment effects and safety. Participants remain under medical observation throughout the trial, with follow-up visits to monitor health and response.

A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL