A Study of BI-1206 in Combination With Rituximab in Subjects With Indolent B-Cell Non-Hodgkin Lymphoma
Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary
18 Years and older, Male and Female
17-BI1206-02 (primary)
NCI-2018-02697
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).
Eligibility
- 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 FL grade 3B), MCL and marginal zone lymphoma (MZL).
- Have measurable 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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