A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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
Eligibility
Primary outcome measure(s)
- Documenting AEs and SAEs and determining causality in relation to BI-1206 and/or rituximab and/or acalabrutinib — During the 28-day treatment period on induction therapy
Assess the safety and tolerability profile of BI-1206 when administered intravenously (IV) or subcutaneously (SC) in combination with rituximab or rituximab and acalabrutinib in subjects with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL), subtypes follicular lymphoma (FL)(except FL grade 3B), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL). Assessment will be done according to National Cancer Institute (NCI-CTCAE) criteria v. 5.0. - Determining the MTD of BI-1206 at the same dose level experiencing a BI-1206 or Rituximab-related or possibly related dose-limiting toxicity (DLT) — During the 28-day treatment period on induction therapy
Phase 1: Select the recommended Phase 2 dose (RP2D) by establishing the maximum tolerated dose (MTD) of BI-1206 given once weekly for 4 weeks, via IV infusion or SC injection in combination with rituximab. - Determine the recommended dose of BI-1206 in combination with rituximab and acalabrutinib — During the 28-day treatment period on induction therapy
Phase 2a: Select the recommended dose of BI-1206 in combination with rituximab and acalabrutinib.
Trial sites (27)
| Facility | City | Region | Status |
|---|---|---|---|
| Emory University Hospital | Atlanta | Georgia | Active Not Recruiting |
| Norton Cancer Institute - St. Matthews 3991 Dutchmans Lane Medical Plaza II, Suite 405 | Louisville | Kentucky | Recruiting |
| Hospital São Rafael | Salvador | Estado de Bahia | Recruiting |
| Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | Recruiting |
| Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer | Curitiba | Brazil | Not Yet Recruiting |
| Ruschel Medicina e Pesquisa Clínica | Rio de Janeiro | Brazil | Not Yet Recruiting |
| A.C. Camargo Cancer Center | São Paulo | Brazil | Recruiting |
| Hospital Amaral Carvalho | São Paulo | Brazil | Not Yet Recruiting |
| Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo | São Paulo | Brazil | Not Yet Recruiting |
| Hospital Israelita Albert Einstein | São Paulo | Brazil | Recruiting |
| Hospital Samaritano | São Paulo | Brazil | Not Yet Recruiting |
| Hospital Sírio-Libanês | São Paulo | Brazil | Not Yet Recruiting |
| Krankenhaus Nordwest Klinik für Onkologie und Hämatologie | Frankfurt am Main | Hesse | Not Yet Recruiting |
| Robert Bosch Hospital, Dep of Hematology, Oncology and Palliative care | Stuttgart | Germany | Withdrawn |
| Szpital Specjlistyczny | Grudziądz | Poland | Terminated |
| Małopolskie Centrum Medyczne | Krakow | Poland | Terminated |
| Hospital ICO, Trias i Pujol | Badalona | Barcelona | Recruiting |
| Hospital de la Santa Creu i Sant Pau, Dep Hematologia | Barcelona | Barcelona | Recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona | Barcelona | Recruiting |
| Hospital General Universitario Gregorio Marañon-Oncología Médica | Madrid | Madrid | Recruiting |
| Hospital Universitario HM Sanchinarro | Madrid | Madrid | Recruiting |
| Hospital Universitario Virgen de la Arrixaca | Murcia | Murcia | Not Yet Recruiting |
| Hospital University Virgen Macarene | Seville | Seville | Recruiting |
| Institut Català d'Oncologia, L'Hospitalet de Llobregat | Barcelona | Spain | Recruiting |
| University Hospital Fundacion Jimenez Diaz | Madrid | Spain | Recruiting |
| Department of Oncology, Academical Hospital | Uppsala | Sweden | Terminated |
| Department of Oncology, Skåne University Hospital | Lund | Sweden | Terminated |
More BioInvent International AB trials in Poland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03571568 on ClinicalTrials.gov ↗ ← All trials in Poland