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A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Adult Participants With Aggressive B-cell Non-Hodgkin Lymphomas
Sponsor: Regeneron Pharmaceuticals
Summary
This study is researching an experimental drug called REGN5837 in combination with another drug, odronextamab (called "study drug\[s\]"), in patients with relapsed or refractory aggressive B-cell Non-Hodgkin Lymphomas (B-NHLs). The study has 2 parts. The aim of the first part (dose escalation) is to find a safe dose of REGN5837 when given in combination with odronextamab. The goal of the second part (dose expansion) is to use the REGN5837 drug dose found in the first part to see how well REGN5837 in combination with odronextamab works. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drugs (that could make the drugs less effective or could lead to side effects)
Official title: A Phase 1 Study to Assess Safety and Tolerability of REGN5837, an Anti-CD22 x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination With Odronextamab, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients With Aggressive B-Cell Non-Hodgkin Lymphomas (ATHENA-1)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
107
Start Date
2023-04-20
Completion Date
2030-01-13
Last Updated
2026-05-19
Healthy Volunteers
No
Conditions
Interventions
Odronextamab
Administered per the protocol
REGN5837
Administered per the protocol
Locations (20)
City of Hope
Duarte, California, United States
University of California Los Angeles (UCLA) Medical Center
Santa Monica, California, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Harvard Medical School - Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
NYU Langone Health Perlmutter Cancer Center
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
UT Southwestern
Dallas, Texas, United States
CHU de Bordeaux
Talence, New Aquitaine, France
Hopital Saint Louis
Paris, France
Gustave Roussy
Villejuif, Île-de-France Region, France
Erasmus Medical Center Rotterdam
Rotterdam, South Holland, Netherlands
Amsterdam University Medical Centre, location AMC
Amsterdam, Netherlands
Hospital Vall d'Hebron
Barcelona, Spain
University Hospital and Research Institute
Madrid, Spain
Royal Cornwall Hospitals NHS Trust, Royal Cornwall Hospital
Truro, Cornwall, United Kingdom
Southampton General Hospital
Southampton, Hampshire, United Kingdom
Western General Hospital
Edinburgh, Scotland, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom