Last updated 15 months ago

A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL

140 patients around the world

Available in Spain, Brazil, United States

This is a Phase 1/2a, multicenter, dose escalation, consecutive-cohort, open-label trial of BI-1206 in combination with rituximab with or without acalabrutinib in subjects with indolent relapsed or refractory B-cell NHL, sub-types FL (except FL grade 3B), MZL, and MCL. Phase 2a, consists of signal seeking cohorts followed by a randomized, parallel, two-arm dose optimization. The trial consists of 2 main parts: Phase 1 - Dose Escalation, with two different Arms assessing IV or SC dosing of BI-1206 in combination with rituximab, with dose escalation cohorts and selection of the IV and SC doses of BI-1206 for Phase 2a Phase 2a - Dose Expansion, with one expansion cohort evaluating the selected IV dose of BI-1206 in combination with rituximab - Signal Seeking, assessing IV and SC dosing of BI-1206 in combination with rituximab and acalabrutinib. The Signal Seeking will consist of a Safety Run-in and an Expansion - Dose Optimization to select the recommended dose of BI-1206 in combination with rituximab and acalabrutinib

BioInvent International AB

5Research sites

140Patients 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 São Rafael

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

AC Camargo Cancer Center

São Paulo, 01509-001

Hospital Israelita Albert Einstein

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

Hospital de Clínicas de Porto Alegre (HCPA)

Rua Ramiro Barcelos, 2350, Av. Protásio Alves, 211 - Santa Cecília, Porto Alegre - RS, 90035-903

Study BI-1206

SponsorBioInvent International AB

Study typeInterventional

Conditions

Large B-cell lymphoma

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT03571568