A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL
Start Date
5/16/2018
Completion Date
9/30/2026
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
Detailed Description
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
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
BI-1206
Rituximab
Acalabrutinib
Conditions
Locations
Emory University Hospital
Atlanta, Georgia 30322
United States
Norton Cancer Institute - St. Matthews 3991 Dutchmans Lane Medical Plaza II, Suite 405
Louisville, Kentucky 40207
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, 86-300
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, SE-22185
Sweden
Department of Oncology, Academical Hospital
Uppsala, 751 85
Sweden