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RECRUITING
NCT03571568
PHASE1/PHASE2

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

Sponsor: BioInvent International AB

View on ClinicalTrials.gov

Summary

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

Official title: Phase 1/2a 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 Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2018-05-16

Completion Date

2026-09-30

Last Updated

2025-04-24

Healthy Volunteers

No

Interventions

BIOLOGICAL

BI-1206

BI-1206 150 mg / 225 mg Subcutaneous injection BI-1206 50 mg /100 mg Intravenous infusion

BIOLOGICAL

Rituximab

Rituximab 375 mg/m2, as per SmPC

BIOLOGICAL

Acalabrutinib

Acalabrutinib 100 mg orally as per SmPC

Locations (27)

Emory University Hospital

Atlanta, Georgia, United States

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

Louisville, Kentucky, United States

Hospital São Rafael

Salvador, Estado de Bahia, Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

Curitiba, Brazil

Ruschel Medicina e Pesquisa Clínica

Rio de Janeiro, Brazil

A.C. Camargo Cancer Center

São Paulo, Brazil

Hospital Amaral Carvalho

São Paulo, Brazil

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, Brazil

Hospital Israelita Albert Einstein

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

Hospital ICO, Trias i Pujol

Badalona, Barcelona, Spain

Hospital de la Santa Creu i Sant Pau, Dep Hematologia

Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Institut Català d'Oncologia, L'Hospitalet de Llobregat

Barcelona, Spain

Hospital General Universitario Gregorio Marañon-Oncología Médica

Madrid, Spain

Hospital Universitario HM Sanchinarro

Madrid, Spain

University Hospital Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario Virgen de la Arrixaca

Murcia, Spain

Hospital University Virgen Macarene

Seville, Spain

Department of Oncology, Skåne University Hospital

Lund, Sweden

Department of Oncology, Academical Hospital

Uppsala, Sweden