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A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL
Sponsor: BioInvent International AB
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
Conditions
Interventions
BI-1206
BI-1206 150 mg / 225 mg Subcutaneous injection BI-1206 50 mg /100 mg Intravenous infusion
Rituximab
Rituximab 375 mg/m2, as per SmPC
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