RecruitingPhase 1NCT05685173

A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Adult Participants With Aggressive B-cell Non-Hodgkin Lymphomas

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)

Sponsor

Regeneron Pharmaceuticals

Enrollment

107 participants

Start Date

Apr 20, 2023

Study Type

INTERVENTIONAL

Conditions

B-cell Non-Hodgkins Lymphoma (B-NHL)

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)

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a combination of two experimental antibody drugs — REGN5837 and odronextamab — is safe and effective for adults with aggressive B-cell non-Hodgkin lymphoma (a type of blood cancer) that has come back or not responded to prior therapies. **You may be eligible if...** - You are an adult with aggressive B-cell non-Hodgkin lymphoma that has a protein called CD20 on its surface - Your lymphoma has come back or progressed after at least 2 prior treatment regimens that included an anti-CD20 antibody and an alkylating agent - You have measurable disease on imaging - You are in good enough physical health to participate (ECOG 0–1) - Your bone marrow, kidney, and liver function are acceptable - Tumor tissue is available for laboratory testing **You may NOT be eligible if...** - You have had an allogeneic stem cell transplant or solid organ transplant - You have already been treated with odronextamab or a similar CD20xCD3 bispecific antibody - You have mantle cell lymphoma - You have lymphoma in your brain or central nervous system - You received cancer treatment within 14 days (or 5 half-lives) before starting the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOdronextamab

Administered per the protocol

DRUGREGN5837

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

View Full Details on ClinicalTrials.gov

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NCT05685173