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

NCT05685173 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: R5837-ONC-20192020-005084-322022-502137-26-00
• Study Type: interventional
• Target: 107
• Locations: 5 countries
• Sites: 20

Brief 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)

Conditions

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

Keywords

Aggressive B-Cell Non-Hodgkin Lymphomas; Relapsed or Refractory

Outcome Measures

Primary Outcomes (5)

• Incidence of Dose Limiting Toxicities (DLTs) of REGN5837 in combination with odronextamab

  A DLT is defined as any non-haematologic and haematologic toxicity, as defined in the protocol, unless the event is clearly attributable to the underlying disease or to an extraneous cause (including concomitant medications).

  From Cycle 2, Day 1 to Cycle 2, Day 21 (each induction cycle is 21 days)

• Incidence of Treatment-Emergent Adverse Events (TEAEs) of REGN5837 in combination with odronextamab

  Treatment-emergent adverse events (TEAEs) are defined as those AEs that newly occurred or worsened during the on-treatment period and any treatment-related serious adverse events (SAEs) that occurred during the post-treatment period.

  Up to approximatively 5 years

• Severity of TEAEs of REGN5837 in combination with odronextamab

  Treatment-emergent adverse events (TEAEs) are defined as those AEs that newly occurred or worsened during the on-treatment period and any treatment-related serious adverse events (SAEs) that occurred during the post-treatment period.

  Up to approximatively 5 years

• Incidence of Adverse Events of Special Interest (AESIs) of REGN5837 in combination with odronextamab

  An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate.

  Up to approximatively 5 years

• Severity of AESIs of REGN5837 in combination with odronextamab

  An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate.

  Up to approximatively 5 years

Secondary Outcomes (11)

• Concentrations of REGN5837 in the serum

  Up to 90 days post last study drug administration

• Concentrations of odronextamab in the serum

  Up to 90 days post last study drug administration

• Occurrence of Anti-Drug Antibodies (ADAs) to REGN5837

  Up to 90 days post last study drug administration

• Occurrence of ADAs to odronextamab

  Up to 90 days post last study drug administration

• Magnitude of ADAs to REGN5837

  Up to 90 days post last study drug administration

Study Arms (2)

Dose escalation portion

EXPERIMENTAL

Drug: Odronextamab; Drug: REGN5837

Dose expansion portion

EXPERIMENTAL

Drug: Odronextamab; Drug: REGN5837

Interventions

Odronextamab DRUG

Administered per the protocol

Also known as: REGN1979, Ordspono™

Dose escalation portion; Dose expansion portion

REGN5837 DRUG

Administered per the protocol

Dose escalation portion; Dose expansion portion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Measurable disease on cross sectional imaging as defined in the protocol
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Adequate bone marrow, renal and hepatic function as defined in the protocol
• 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
• 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.

You may not qualify if:

• Prior treatments with allogeneic stem cell transplantation or solid organ transplantation, treatment with anti-CD20 x anti- CD3 bispecific antibody, such as odronextamab
• Diagnosis of Mantle Cell Lymphoma (MCL)
• Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS lymphoma, as described in the protocol
• 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
• Standard radiotherapy within 14 days of first administration of study drug, as described in the protocol
• Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or corticosteroid equivalent within 72 hours of start of odronextamab
• Co-morbid conditions, as described in the protocol
• Infections, as described in the protocol
• Allergy/hypersensitivity: Known hypersensitivity to both allopurinol and rasburicase

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (20)

City of Hope

Duarte, California, 91010, United States

RECRUITING

University of California Los Angeles (UCLA) Medical Center

Santa Monica, California, 90404, United States

RECRUITING

Norton Cancer Institute

Louisville, Kentucky, 40207, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Harvard Medical School - Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

RECRUITING

NYU Langone Health Perlmutter Cancer Center

New York, New York, 10016, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

UT Southwestern

Dallas, Texas, 75390, United States

RECRUITING

CHU de Bordeaux

Talence, New Aquitaine, 33404, France

RECRUITING

Hopital Saint Louis

Paris, 75010, France

RECRUITING

Gustave Roussy

Villejuif, Île-de-France Region, 94800, France

RECRUITING

Erasmus Medical Center Rotterdam

Rotterdam, South Holland, 3015, Netherlands

RECRUITING

Amsterdam University Medical Centre, location AMC

Amsterdam, 1100AZ, Netherlands

RECRUITING

Hospital Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

University Hospital and Research Institute

Madrid, 28041, Spain

RECRUITING

Royal Cornwall Hospitals NHS Trust

Truro, Cornwall, TR1 3LJ, United Kingdom

RECRUITING

Southampton General Hospital

Southampton, Hampshire, SO16 6YD, United Kingdom

RECRUITING

Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

RECRUITING

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: January 13, 2023
• Study Start: April 20, 2023
• Primary Completion (Estimated): February 16, 2029
• Study Completion (Estimated): January 13, 2030
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

US (9); FR (3); ES (2); GB (4); NL (2)