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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


Description

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 RituximabThis 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

Trial Eligibility

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 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 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 any of 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

Study Info

Organization

BioInvent International AB


Primary Outcome

Documenting AEs and SAEs and determining causality in relation to BI-1206 and/or rituximab


Outcome Timeframe During the 28-day treatment period on induction therapy

NCTID NCT03571568

Phases PHASE1,PHASE2

Primary Purpose TREATMENT

Start Date 2018-05-16

Completion Date 2025-09-22

Enrollment Target 98

Interventions

BIOLOGICAL BI-1206

Locations Recruiting

Emory University Hospital

United States, Georgia, Atlanta


Norton Cancer Institute - St. Matthews 3991 Dutchmans Lane Medical Plaza II, Suite 405

United States, Kentucky, Louisville


Hospital São Rafael

Brazil, Bahia, Salvador


Hospital de Clínicas de Porto Alegre

Brazil, Rio Grande Do Sul, Porto Alegre


A.C. Camargo Cancer Center

Brazil, São Paulo


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