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RECRUITING
NCT05685173
PHASE1

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

View on ClinicalTrials.gov

Summary

The study is researching an experimental drug called REGN5837 in combination with another experimental drug, odronextamab (called "study drugs"). The aim of the study is to see how safe and tolerable the study drugs are, and to define the recommended dose for phase 2. 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) * To find out how well the study drugs work against relapsed or refractory aggressive B-cell non-Hodgkin lymphomas (B-NHLs)

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

91

Start Date

2023-04-12

Completion Date

2029-05-16

Last Updated

2026-03-30

Healthy Volunteers

No

Interventions

DRUG

Odronextamab

Odronextamab will be administered by IV infusion

DRUG

REGN5837

REGN5837 will be administered by IV infusion

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, Nouvelle-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

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