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

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.