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

Recruiting now · Phase 1/Phase 2

Conditions studied: Indolent B-Cell Non-Hodgkin Lymphoma

In brief

Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination with Rituximab with or without Acalabrutinib in Subjects with Indolent B-Cell Non-Hodgkin Lymphoma That has Relapsed or is Refractory to Rituximab

Key facts

Study ID: NCT03571568
Run by: BioInvent International AB
People needed: 140
Starts: 2018-05-16
Expected to finish: 2026-09-30
Last updated by the study team: 2025-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 FL grade 3B,
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
Previous lines of treatment containing BTK inhibitors for Subjects receiving BI-1206 in combination with rituximab and acalabrutinib
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

Where it is running

Hospital Israelita Albert Einstein — São Paulo, Brazil (enrolling)
Hospital São Rafael — Salvador, Estado de Bahia, Brazil (enrolling)
Hospital ICO, Trias i Pujol — Badalona, Barcelona, Spain (enrolling)
Hospital de la Santa Creu i Sant Pau, Dep Hematologia — Barcelona, Spain (enrolling)
Hospital Universitari Vall d'Hebron — Barcelona, Spain (enrolling)
Institut Català d'Oncologia, L'Hospitalet de Llobregat — Barcelona, Spain (enrolling)
Hospital General Universitario Gregorio Marañon-Oncología Médica — Madrid, Spain (enrolling)
Hospital Universitario HM Sanchinarro — Madrid, Spain (enrolling)
University Hospital Fundacion Jimenez Diaz — Madrid, Spain (enrolling)
A.C. Camargo Cancer Center — São Paulo, Brazil (enrolling)
Hospital University Virgen Macarene — Seville, Spain (enrolling)
Hospital de Clínicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
Norton Cancer Institute - St. Matthews 3991 Dutchmans Lane Medical Plaza II, Suite 405 — Louisville, Kentucky, United States (enrolling)
Emory University Hospital — Atlanta, Georgia, United States
Department of Oncology, Academical Hospital — Uppsala, Sweden
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer — Curitiba, Brazil
Ruschel Medicina e Pesquisa Clínica — Rio de Janeiro, Brazil
Hospital Amaral Carvalho — São Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo — São Paulo, Brazil
Hospital Samaritano — São Paulo, Brazil
Hospital Sírio-Libanês — São Paulo, Brazil
Krankenhaus Nordwest Klinik für Onkologie und Hämatologie — Frankfurt am Main, Hesse, Germany
Robert Bosch Hospital, Dep of Hematology, Oncology and Palliative care — Stuttgart, Germany
Szpital Specjlistyczny — Grudziądz, Poland
Małopolskie Centrum Medyczne — Krakow, Poland

Full record on ClinicalTrials.gov

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