A Study of BI-1206 in Combination With Rituximab in Subjects With Indolent B-Cell Non-Hodgkin Lymphoma

Active:	Yes
Cancer Type:	Hematopoietic Malignancies Lymphoma Non-Hodgkin Lymphoma Unknown Primary	NCT ID:	NCT03571568
Trial Phases:	Phase I Phase II	Protocol IDs:	17-BI1206-02 (primary) NCI-2018-02697
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	BioInvent International AB
NCI Full Details:	http://clinicaltrials.gov/show/NCT03571568

Summary

Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in
Combination with Rituximab in Subjects with Indolent B-Cell Non-Hodgkin Lymphoma That has
Relapsed or is Refractory to Rituximab

Objectives

This is a Phase 1/2a, dose escalation, consecutive-cohort, open-label trial of BI-1206 in
combination with rituximab in subjects with indolent relapsed or refractory B-cell NHL,
subtypes FL (except FL grade 3B), MZL, and MCL.

The trial consists of 2 main parts:

- Phase 1 with two different Arms assessing IV or SC dosing of BI-1206,with dose
escalation cohorts and selection of the RP2D of IV dosing (ivRP2D)and the RP2D of SC
dosing (scRP2D) of BI-1206 in combination with rituximab (administered IV).

- Phase 2a with two expansion cohorts evaluating the ivRP2D and scRP2D of BI-1206 in
combination with rituximab (administered IV).

Subjects in each phase (Phase 1 and 2a) and dosing Arms will receive 1 cycle of induction
therapy with BI-1206 in combination with rituximab.

Subjects who show clinical benefit (complete response [CR], partial response [PR], or stable
disease [SD]) at Week 6 will continue onto maintenance therapy and receive BI-1206 ( using
the same dose and route of administration as induction therapy) and rituximab once every 8
weeks (relative to previous maintenance dose) for up to 6 maintenance cycles, or up to 1 year
from first dose of BI-1206 (whichever occurs first).

Treatment Sites in Georgia

Emory University Hospital - Atlanta
1364 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

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