A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL
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
1 other identifier
interventional
140
6 countries
27
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2018
Longer than P75 for phase_1
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 16, 2018
CompletedFirst Submitted
Initial submission to the registry
May 17, 2018
CompletedFirst Posted
Study publicly available on registry
June 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
April 24, 2025
April 1, 2025
8.4 years
May 17, 2018
April 23, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Documenting AEs and SAEs and determining causality in relation to BI-1206 and/or rituximab and/or acalabrutinib
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.
During the 28-day treatment period on induction therapy
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)
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.
During the 28-day treatment period on induction therapy
Determine the recommended dose of BI-1206 in combination with rituximab and acalabrutinib
Phase 2a: Select the recommended dose of BI-1206 in combination with rituximab and acalabrutinib.
During the 28-day treatment period on induction therapy
Secondary Outcomes (4)
Evaluation of PK parameters for BI-1206
Up to 1 year
Evaluation of ADA (immunogenicity) response to BI-1206
Up to 1 year
Measurement of peripheral blood B-lymphocytes depletion
Up to 1 year
Assessment of overall response rate (ORR) according to the response criteria for malignant lymphoma (Cheson, 2014).
Up to 1 year
Other Outcomes (4)
Expression levels of CD32b protein
Up to 1 year
Assessment of Patient Reported Outcomes using the NCI PRO-CTCAE questionnaire
Up to 1 year
Expression levels of CD32b and/or other immunological markers
Up to 1 year
- +1 more other outcomes
Study Arms (5)
BI-1206 IV Dose Escalation
EXPERIMENTALStandard 3+3 Dose-Escalation of BI-1206 IV in combination with Rituximab
BI-1206 SC Dose Escalation
EXPERIMENTALAdaptive Dose Escalation of BI-1206 SC (Bayesian logistic regression model (BLRM) in combination with Rituximab
Phase 2a IV Dose expansion
EXPERIMENTALBI-1206 IV in Combination with Rituximab
Phase 2a SC Signal seeking
EXPERIMENTALSC Arm, BI-1206 in Combination with Rituximab and Acalabrutinib
Phase 2a IV Signal Seeking
EXPERIMENTALIV Arm, BI-1206 in Combination with Rituximab and Acalabrutinib
Interventions
BI-1206 150 mg / 225 mg Subcutaneous injection BI-1206 50 mg /100 mg Intravenous infusion
Rituximab 375 mg/m2, as per SmPC
Acalabrutinib 100 mg orally as per SmPC
Eligibility Criteria
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).
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2018
First Posted
June 27, 2018
Study Start
May 16, 2018
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
April 24, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- Within one year from end of study
- Access Criteria
- Paper copy of CSR
All information concerning the product as well as any matter concerning the operation of the Sponsor, such as clinical indications for the drug, its formula, methods of manufacture and other scientific data relating to it, that have been provided by the Sponsor and are unpublished, are confidential and must remain the sole property of the Sponsor. The Investigator will agree to use the information only for the purposes of carrying out this study and for no other purpose unless prior written permission from the Sponsor is obtained.