Georgia's Online Cancer Information Center

Find A Clinical Trial

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

Status
Active
Cancer Type
Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary
Trial Phase
Phase I
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03571568
Protocol IDs
17-BI1206-02 (primary)
NCI-2018-02697
Study Sponsor
BioInvent International AB

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 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).

Eligibility

  1. Are = 18 years of age by initiation of study treatment.
  2. Have B-cell NHL proven by histology, with histological subtypes limited to follicular lymphoma (FL) (except FL3B), MCL and marginal zone lymphoma (MZL).
  3. Have measureable nodal disease
  4. Are willing to undergo lymph node biopsies or biopsies of other involved tissue
  5. Have relapsed disease or disease refractory to conventional treatment or for which no standard therapy exists.
  6. Have received at least one line of conventional previous therapy which must include at least one rituximab-based regimen.
  7. Have a life expectancy of at least 12 weeks
  8. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  9. Have CD20+ malignancy
  10. Have hematological and biochemical indices within prespecified ranges

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.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.