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

Who is this study for? Adult patients with Indolent B Cell Non-Hodgkin's Lymphoma
What treatments are being studied? BI1206 Anti-CD32b Monoclonal Antibody
Status: Recruiting
Location: See all (22) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Georgia
Emory University Hospital
TERMINATED
Atlanta
Kentucky
Norton Cancer Institute - St. Matthews 3991 Dutchmans Lane Medical Plaza II, Suite 405
RECRUITING
Louisville
Other Locations
Brazil
Hospital de Clínicas de Porto Alegre
RECRUITING
Porto Alegre
Hospital São Rafael
RECRUITING
Salvador
A.C. Camargo Cancer Center
RECRUITING
São Paulo
Hospital Israelita Albert Einstein
RECRUITING
São Paulo
Hospital Sírio-Libanês
NOT_YET_RECRUITING
São Paulo
Germany
Krankenhaus Nordwest Klinik für Onkologie und Hämatologie
NOT_YET_RECRUITING
Frankfurt
Robert Bosch Hospital, Dep of Hematology, Oncology and Palliative care
TERMINATED
Stuttgart
Poland
Szpital Specjlistyczny
TERMINATED
Grudziadz
Małopolskie Centrum Medyczne
TERMINATED
Krakow
Spain
Hospital ICO, Trias i Pujol
RECRUITING
Badalona
Hospital de la Santa Creu i Sant Pau, Dep Hematologia
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Institut Català d'Oncologia, L'Hospitalet de Llobregat
RECRUITING
Barcelona
Hospital General Universitario Gregorio Marañon-Oncología Médica
RECRUITING
Madrid
Hospital Universitario HM Sanchinarro
RECRUITING
Madrid
University Hospital Fundacion Jimenez Diaz
RECRUITING
Madrid
Hospital Universitario Virgen de la Arrixaca
NOT_YET_RECRUITING
Murcia
Hospital University Virgen Macarene
RECRUITING
Seville
Sweden
Department of Oncology, Skåne University Hospital
TERMINATED
Lund
Department of Oncology, Academical Hospital
TERMINATED
Uppsala
Contact Information
Primary
Erika Bågeman
erika.bageman@bioinvent.com
+46706126618
Backup
Andres McAllister, MD, PhD
andres.mcallister@bioinvent.com
Time Frame
Start Date: 2018-05-16
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 140
Treatments
Experimental: BI-1206 IV Dose Escalation
Standard 3+3 Dose-Escalation of BI-1206 IV in combination with Rituximab
Experimental: BI-1206 SC Dose Escalation
Adaptive Dose Escalation of BI-1206 SC (Bayesian logistic regression model (BLRM) in combination with Rituximab
Experimental: Phase 2a IV Dose expansion
BI-1206 IV in Combination with Rituximab
Experimental: Phase 2a SC Signal seeking
SC Arm, BI-1206 in Combination with Rituximab and Acalabrutinib
Experimental: Phase 2a IV Signal Seeking
IV Arm, BI-1206 in Combination with Rituximab and Acalabrutinib
Related Therapeutic Areas
Sponsors
Leads: BioInvent International AB

This content was sourced from clinicaltrials.gov