Recruiting
Phase 1

REGN5837 & Odronextamab

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT05685173

Conditions

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Odronextamab

REGN5837

Study Details

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)

Study ID

NCT05685173

Start date

Apr 20, 2023

Status verified date

May, 2026

Completion date

Jan 13, 2030

Anticipated

Primary completion date

Feb 16, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

107 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose escalation portion

experimental: Dose expansion portion

Interventions

Odronextamab

Administered per the protocol

REGN5837

Administered per the protocol

Primary outcome measure

  • Incidence of Dose Limiting Toxicities (DLTs) of REGN5837 in combination with odronextamab [ Time Frame: 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 [ Time Frame: Up to approximatively 5 years ]
  • Severity of TEAEs of REGN5837 in combination with odronextamab [ Time Frame: Up to approximatively 5 years ]
  • Incidence of Adverse Events of Special Interest (AESIs) of REGN5837 in combination with odronextamab [ Time Frame: Up to approximatively 5 years ]
  • Severity of AESIs of REGN5837 in combination with odronextamab [ Time Frame: Up to approximatively 5 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

University of California Los Angeles (UCLA) Medical Center

Recruiting

Santa Monica, California, United States, 90404

Norton Cancer Institute

Recruiting

Louisville, Kentucky, United States, 40207

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Harvard Medical School - Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08901

NYU Langone Health Perlmutter Cancer Center

Recruiting

New York, New York, United States, 10016

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

UT Southwestern

Recruiting

Dallas, Texas, United States, 75390

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

May 19, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-05-19.