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NCT05685173PHASE1Recruiting

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

Regeneron Pharmaceuticals

Start Date

4/20/2023

Completion Date

1/13/2030

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 Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: 1. Have documented CD20+ aggressive B-NHL, with disease that has progressed after at least 2 lines of systemic therapy containing an anti-CD20 antibody and an alkylating agent, as described in the protocol. 2. Measurable disease on cross sectional imaging as defined in the protocol 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 4. Adequate bone marrow, renal and hepatic function as defined in the protocol 5. Availability of tumor tissue for submission to central laboratory is required for study enrollment. Archival tumor tissue for histological assessment prior to enrollment is allowed 6. During dose expansion phase of the study, participant should be willing to undergo mandatory tumor biopsies, if in the opinion of the investigator, the participant has an accessible lesion that can be biopsied without significant risk to the participant. Key Exclusion Criteria: 1. Prior treatments with allogeneic stem cell transplantation or solid organ transplantation, treatment with anti-CD20 x anti- CD3 bispecific antibody, such as odronextamab 2. Diagnosis of Mantle Cell Lymphoma (MCL) 3. Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS lymphoma, as described in the protocol 4. Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 14 days prior to first administration of study drug, whichever is shorter, as described in the protocol 5. Standard radiotherapy within 14 days of first administration of study drug, as described in the protocol 6. Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or corticosteroid equivalent within 72 hours of start of odronextamab 7. Co-morbid conditions, as described in the protocol 8. Infections, as described in the protocol 9. Allergy/hypersensitivity: Known hypersensitivity to both allopurinol and rasburicase NOTE: Other protocol defined inclusion / exclusion criteria apply

Interventions

DRUG

Odronextamab

DRUG

REGN5837

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Conditions

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

Locations

City of Hope

Duarte, California 91010

United States

University of California Los Angeles (UCLA) Medical Center

Santa Monica, California 90404

United States

Norton Cancer Institute

Louisville, Kentucky 40207

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Harvard Medical School - Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey 08901

United States

NYU Langone Health Perlmutter Cancer Center

New York, New York 10016

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

UT Southwestern

Dallas, Texas 75390

United States

CHU de Bordeaux

Talence, New Aquitaine 33404

France

Hopital Saint Louis

Paris, 75010

France

Gustave Roussy

Villejuif, Île-de-France Region 94800

France

Erasmus Medical Center Rotterdam

Rotterdam, South Holland 3015

Netherlands

Amsterdam University Medical Centre, location AMC

Amsterdam, 1100AZ

Netherlands

Hospital Vall d'Hebron

Barcelona, 08035

Spain

University Hospital and Research Institute

Madrid, 28041

Spain

Royal Cornwall Hospitals NHS Trust, Royal Cornwall Hospital

Truro, Cornwall TR1 3LJ

United Kingdom

Southampton General Hospital

Southampton, Hampshire SO16 6YD

United Kingdom

Western General Hospital

Edinburgh, Scotland EH4 2XU

United Kingdom

The Christie NHS Foundation Trust

Manchester, M20 4BX

United Kingdom