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New drug duo takes on tough lymphoma

NCT ID NCT05685173

Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests an experimental drug called REGN5837 combined with the approved drug odronextamab for people with aggressive B-cell lymphoma that has come back or not responded to prior treatments. The study first finds a safe dose, then checks how well the combo works. About 107 participants will be enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
REGN5837 (an experimental immune-boosting drug) combined with odronextamab (an approved lymphoma drug)
What this could lead to
If this works, it could offer a new treatment option for people with aggressive B-cell lymphoma that has not responded to other therapies.
What could go wrong
This is an early Phase 1 trial with only 107 participants, so it is too soon to know if the combination is safe or effective. Side effects are possible, and the drugs may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 107 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

aggressive B-cell non-Hodgkin lymphoma B-cell non-Hodgkin lymphoma Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

B-cell non-hodgkins lymphoma (B-NHL)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Amsterdam University Medical Centre, location AMC

    RECRUITING

    Amsterdam, 1100AZ, Netherlands

  • CHU de Bordeaux

    RECRUITING

    Talence, New Aquitaine, 33404, France

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • Erasmus Medical Center Rotterdam

    RECRUITING

    Rotterdam, South Holland, 3015, Netherlands

  • Gustave Roussy

    RECRUITING

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

  • Harvard Medical School - Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Hopital Saint Louis

    RECRUITING

    Paris, 75010, France

  • Hospital Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • NYU Langone Health Perlmutter Cancer Center

    RECRUITING

    New York, New York, 10016, United States

  • Norton Cancer Institute

    RECRUITING

    Louisville, Kentucky, 40207, United States

  • Royal Cornwall Hospitals NHS Trust, Royal Cornwall Hospital

    RECRUITING

    Truro, Cornwall, TR1 3LJ, United Kingdom

  • Rutgers Cancer Institute of New Jersey

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Southampton General Hospital

    RECRUITING

    Southampton, Hampshire, SO16 6YD, United Kingdom

  • The Christie NHS Foundation Trust

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • UT Southwestern

    RECRUITING

    Dallas, Texas, 75390, United States

  • University Hospital and Research Institute

    RECRUITING

    Madrid, 28041, Spain

  • University of California Los Angeles (UCLA) Medical Center

    RECRUITING

    Santa Monica, California, 90404, United States

  • Western General Hospital

    RECRUITING

    Edinburgh, Scotland, EH4 2XU, United Kingdom

More trials for these conditions

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