Last updated 10 months ago

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

98 patients around the world

Available in Spain, Brazil, United States

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).

BioInvent International AB

5Research sites

98Patients around the world

This study is for people with

Non-Hodgkin Lymphoma

Large B-cell lymphoma

Requirements for the patient

From 18 Years

All Gender

Medical requirements

: 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.

: 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.

Sites

Hospital Sao Rafael

Av. São Rafael, 2152 - São Marcos, Salvador - BA, 41253-190

Hospital de Clínicas de Porto Alegre

Santa Cecília, Porto Alegre - RS, 90450-190, Brazil

AC Camargo Cancer Center

São Paulo, 01509-001

Hospital Israelita Albert Einstein - Fortaleza, Ceara

Avenida Albert Einstein 627/701, 2° Subsolo - Bloco A, Centro de Pesquisa Clínica, São Paulo, Sao Paulo

Sociedade Beneficente de Senhoras Hospital Sirio Libanes

R. Dr. Albuquerque Lins, 40 - Santa Cecilia, São Paulo - SP, 01230-001, Brazil

SponsorBioInvent International AB

Conditions

Large B-cell lymphoma

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT03571568