Actively Recruiting
A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL
Led by BioInvent International AB · Updated on 2025-04-24
140
Participants Needed
27
Research Sites
437 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the start of study treatment
- Diagnosed with B-cell non-Hodgkin lymphoma of follicular lymphoma (except grade 3B), mantle cell lymphoma, or marginal zone lymphoma subtypes
- Measurable nodal disease present
- Willingness to undergo lymph node or other tissue biopsies
- Disease that has relapsed, is refractory to conventional treatment, or has no standard therapy
- At least one prior conventional therapy including at least one rituximab-based regimen
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Malignancy expressing CD20
- Hematological and biochemical lab values within specified ranges
You will not qualify if you...
- Received allogenic bone marrow or stem cell transplant within the last 12 months
- Active chronic graft versus host disease present
- Current leptomeningeal lymphoma or central nervous system involvement
- Transformed lymphoma from previous indolent lymphoma
- Diagnosis of Waldenstrom's Macroglobulinemia or follicular lymphoma grade 3B
- Need for systemic prednisolone over 10 mg daily (or equivalent corticosteroids) during the study except as pre-medication
- Known or suspected allergy to rituximab or BI-1206
- Cardiac or renal amyloid light-chain amyloidosis
- Received chemotherapy or small molecule treatments within 2 weeks before BI-1206
- Radiotherapy within 4 weeks except for focal symptomatic control
- Immunotherapy within 8 weeks
- Prior treatment with BTK inhibitors for participants receiving BI-1206 with rituximab and acalabrutinib
- Ongoing toxic effects from previous treatments
- Pregnant, breastfeeding, or able to become pregnant
- Recent major surgery not yet recovered from
- High medical risk due to systemic diseases including active infections treated with antibiotics, antifungals, or antivirals
- Positive tests for hepatitis B, hepatitis C, or HIV
- Active or suspected autoimmune disease
- Congestive heart failure or history of severe cardiac disease (NYHA class III/IV)
- Current malignancies other than the lymphoma being studied
AI-Screening
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Trial Site Locations
Total: 27 locations
1
Emory University Hospital
Atlanta, Georgia, United States, 30322
Active, Not Recruiting
2
Norton Cancer Institute - St. Matthews 3991 Dutchmans Lane Medical Plaza II, Suite 405
Louisville, Kentucky, United States, 40207
Actively Recruiting
3
Hospital São Rafael
Salvador, Estado de Bahia, Brazil
Actively Recruiting
4
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Actively Recruiting
5
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer
Curitiba, Brazil
Not Yet Recruiting
6
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, Brazil
Not Yet Recruiting
7
A.C. Camargo Cancer Center
São Paulo, Brazil
Actively Recruiting
8
Hospital Amaral Carvalho
São Paulo, Brazil
Not Yet Recruiting
9
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil
Not Yet Recruiting
10
Hospital Israelita Albert Einstein
São Paulo, Brazil
Actively Recruiting
11
Hospital Samaritano
São Paulo, Brazil
Not Yet Recruiting
12
Hospital Sírio-Libanês
São Paulo, Brazil
Not Yet Recruiting
13
Krankenhaus Nordwest Klinik für Onkologie und Hämatologie
Frankfurt am Main, Hesse, Germany
Not Yet Recruiting
14
Robert Bosch Hospital, Dep of Hematology, Oncology and Palliative care
Stuttgart, Germany
Withdrawn
15
Szpital Specjlistyczny
Grudziądz, Poland, 86-300
Terminated
16
Małopolskie Centrum Medyczne
Krakow, Poland
Terminated
17
Hospital ICO, Trias i Pujol
Badalona, Barcelona, Spain
Actively Recruiting
18
Hospital de la Santa Creu i Sant Pau, Dep Hematologia
Barcelona, Spain
Actively Recruiting
19
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Actively Recruiting
20
Institut Català d'Oncologia, L'Hospitalet de Llobregat
Barcelona, Spain
Actively Recruiting
21
Hospital General Universitario Gregorio Marañon-Oncología Médica
Madrid, Spain
Actively Recruiting
22
Hospital Universitario HM Sanchinarro
Madrid, Spain
Actively Recruiting
23
University Hospital Fundacion Jimenez Diaz
Madrid, Spain
Actively Recruiting
24
Hospital Universitario Virgen de la Arrixaca
Murcia, Spain
Not Yet Recruiting
25
Hospital University Virgen Macarene
Seville, Spain
Actively Recruiting
26
Department of Oncology, Skåne University Hospital
Lund, Sweden, SE-22185
Terminated
27
Department of Oncology, Academical Hospital
Uppsala, Sweden, 751 85
Terminated
Research Team
E
Erika Bågeman
CONTACT
A
Andres McAllister, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
5
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