Atlanta, Georgia 30322

  • Hodgkin Lymphoma

Purpose:

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


Study summary:

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).


Criteria:

Inclusion Criteria: - 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 Exclusion Criteria: - Have had an allogenic bone marrow or stem cell transplant within 12 months - Have presence of active chronic graft versus host disease - Have current leptomeningeal lymphoma or compromise of the central nervous system. - Have transformed lymphoma from a pre-existing indolent lymphoma. - Have Waldenstrom's Macroglobulinemia or FL3B, - Need systemic doses of prednisolone >10 mg daily (or equipotent doses of other corticosteroids) while on the study trial other than as pre-medication. - Have known or suspected hypersensitivity to rituximab or BI-1206. - Have cardiac or renal amyloid light-chain amyloidosis. - Have received the following: - Chemotherapy or small molecule products with 2 weeks of first dose of BI-1206 - Radiotherapy (except for focal symptomatic control of lymphadenopathy) within 4 weeks - Immunotherapy within 8 weeks - Have ongoing toxic manifestations of previous treatments. - Have the ability to become pregnant (or already pregnant or lactating/breastfeeding). - Have had major surgery from which the subject has not yet recovered. - Are at high medical risk because of non-malignant systemic disease including active infection on treatment with antibiotics, antifungals or antivirals. - Are serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV). - Have an active, known or suspected autoimmune disease. - Have concurrent congestive heart failure, prior history of class III/ IV cardiac disease (New York Heart Association [NYHA]), - Have current malignancies of other types


NCT ID:

NCT03571568


Primary Contact:

Principal Investigator
Mats Jerkeman, MD PhD
Senior Consultant and Adjunct Professor, Skane Univ Hospital, Lund, Sweden

Susanne Gertsson
Phone: +46709102267
Email: susanne.gertsson@bioinvent.com


Backup Contact:

Email: andres.mcallister@bioinvent.com
Andres McAllister, MD, PhD


Location Contact:

Atlanta, Georgia 30322
United States

Jonathon Cohen, MD

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 21, 2021

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