NCT03571568

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

Phase 1/2a Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell Non-Hodgkin Lymphoma That Has Relapsed or is Refractory to Rituximab

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: BioInvent International AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination with Rituximab with or without Acalabrutinib in Subjects with Indolent B-Cell Non-Hodgkin Lymphoma That has Relapsed or is Refractory to Rituximab

Detailed description

This is a Phase 1/2a, multicenter, dose escalation, consecutive-cohort, open-label trial of BI-1206 in combination with rituximab with or without acalabrutinib in subjects with indolent relapsed or refractory B-cell NHL, sub-types FL (except FL grade 3B), MZL, and MCL. Phase 2a, consists of signal seeking cohorts followed by a randomized, parallel, two-arm dose optimization. The trial consists of 2 main parts: Phase 1 \- Dose Escalation, with two different Arms assessing IV or SC dosing of BI-1206 in combination with rituximab, with dose escalation cohorts and selection of the IV and SC doses of BI-1206 for Phase 2a Phase 2a * Dose Expansion, with one expansion cohort evaluating the selected IV dose of BI-1206 in combination with rituximab * Signal Seeking, assessing IV and SC dosing of BI-1206 in combination with rituximab and acalabrutinib. The Signal Seeking will consist of a Safety Run-in and an Expansion * Dose Optimization to select the recommended dose of BI-1206 in combination with rituximab and acalabrutinib

Conditions

• Indolent B-Cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	BI-1206	BI-1206 150 mg / 225 mg Subcutaneous injection BI-1206 50 mg /100 mg Intravenous infusion
BIOLOGICAL	Rituximab	Rituximab 375 mg/m2, as per SmPC
BIOLOGICAL	Acalabrutinib	Acalabrutinib 100 mg orally as per SmPC

Timeline

• Start date: 2018-05-16
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2018-06-27
• Last updated: 2025-04-24

Locations

27 sites across 6 countries: United States, Brazil, Germany, Poland, Spain, Sweden

Regulatory

• FDA-regulated drug study