A Study of BI-1206 in Combination With Rituximab in Subjects With Indolent B-Cell Non-Hodgkin Lymphoma
18 Years and older, Male and Female
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
This is a Phase 1/2a, dose escalation, consecutive-cohort, open-label studytrial of BI-1206
in combination with rituximab in subjects with indolent relapsed or refractory B-cell NHL.
The studytrial will consist of 2 main parts: Phase 1 (with dose escalation cohorts using a
3+3 dose-escalation design and selection of the RP2D), and Phase 2a (the escalationexpansion
cohort at the RP2D). Subjects in each phase will receive 1 cycle (4 doses) 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 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).
- Are = 18 years of age by initiation of study treatment.
- Have B-cell NHL proven by histology, with histological subtypes limited to follicular lymphoma (FL) (except FL3B), MCL and marginal zone lymphoma (MZL).
- Have measureable nodal disease
- Are willing to undergo lymph node biopsies or biopsies of other involved tissue
- Have relapsed disease or disease refractory to conventional treatment or for which no standard therapy exists.
- Have received at least one line of conventional previous therapy which must include at least one rituximab-based regimen.
- Have a life expectancy of at least 12 weeks
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Have CD20+ malignancy
- Have hematological and biochemical indices within prespecified ranges
Treatment Sites in Georgia
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