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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

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

Interventions

DRUG

Odronextamab

Administered per the protocol

DRUG

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