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

NCT05685173 · tracked via the Priya Life Science UK tracker

Sponsor

Regeneron Pharmaceuticals

Phase

Phase 1

Started

2023-04-20

Last updated

2026-05-19

Condition(s) studied

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

Investigational drug(s) / intervention(s)

OdronextamabREGN5837

Odronextamab: Administered per the protocol

REGN5837: Administered per the protocol

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Incidence of Dose Limiting Toxicities (DLTs) of REGN5837 in combination with odronextamab — From Cycle 2, Day 1 to Cycle 2, Day 21 (each induction cycle is 21 days)
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).
Incidence of Treatment-Emergent Adverse Events (TEAEs) of REGN5837 in combination with odronextamab — Up to approximatively 5 years
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.
Severity of TEAEs of REGN5837 in combination with odronextamab — Up to approximatively 5 years
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.
Incidence of Adverse Events of Special Interest (AESIs) of REGN5837 in combination with odronextamab — Up to approximatively 5 years
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.
Severity of AESIs of REGN5837 in combination with odronextamab — Up to approximatively 5 years
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.

Trial sites (20)

Facility	City	Region	Status
City of Hope	Duarte	California	Recruiting
University of California Los Angeles (UCLA) Medical Center	Santa Monica	California	Recruiting
Norton Cancer Institute	Louisville	Kentucky	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	Recruiting
Harvard Medical School - Beth Israel Deaconess Medical Center	Boston	Massachusetts	Recruiting
Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey	Recruiting
NYU Langone Health Perlmutter Cancer Center	New York	New York	Recruiting
Icahn School of Medicine at Mount Sinai	New York	New York	Recruiting
UT Southwestern	Dallas	Texas	Recruiting
CHU de Bordeaux	Talence	New Aquitaine	Recruiting
Hopital Saint Louis	Paris	France	Recruiting
Gustave Roussy	Villejuif	Île-de-France Region	Recruiting
Erasmus Medical Center Rotterdam	Rotterdam	South Holland	Recruiting
Amsterdam University Medical Centre, location AMC	Amsterdam	Netherlands	Recruiting
Hospital Vall d'Hebron	Barcelona	Spain	Recruiting
University Hospital and Research Institute	Madrid	Spain	Recruiting
Royal Cornwall Hospitals NHS Trust, Royal Cornwall Hospital	Truro	Cornwall	Recruiting
Southampton General Hospital	Southampton	Hampshire	Recruiting
Western General Hospital	Edinburgh	Scotland	Recruiting
The Christie NHS Foundation Trust	Manchester	United Kingdom	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05685173 on ClinicalTrials.gov ↗ ← All trials in the UK