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Phase 1 trial to investigate the safety and tolerability of REGN9220, an Anti-CD22 x Anti-4-1BB costimulatory bispecific monoclonal antibody, in combination with odronextamab, an Anti-CD20 x Anti-CD3 bispecific monoclonal antibody, in participants with Relapsed/Refractory aggressive B-Cell Non-Hodgkin lymphomas

NCT ID NCT07887750

NEW 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 trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Oct 21, 2026 · Last updated Oct 21, 2026

Summary

This study will test a new experimental study drug called REGN9220 with a Regeneron drug called odronextamab (both called "study drug") to see if it can help treat people with aggressive BCNHL that has either come back/gotten worse or has not responded to previous treatment. The study is looking at: * What side effects REGN9220 might cause when given with odronextamab * How well REGN9220 works when given with odronextamab * How much REGN9220 is in the blood at different times when given with odronextamab * If the body makes antibodies to REGN9220 when given with odronextamab, this may cause the REGN9220 to not work as well * How the body and immune system changes after having REGN9220 given with odronextamab, which can help researchers understand why REGN9220 given with odronextamab works better in some people than others * What is the best dose of REGN9220 when given with odronextamab

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 36 people

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

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Nov 2029

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. Documented Cluster of Differentiation (CD)20+ aggressive B-cell non-Hodgkin lymphoma that is relapsed or refractory 2. Measurable disease on cross sectional imaging 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 4. Adequate organ function (hematologic, hepatic, and renal) 5. Availability of tumor tissue for analysis for submission to central laboratory is required for trial enrollment 6. Willingness to comply with contraception requirements and study procedures Key Exclusion Criteria: 1. Diagnosis of Mantle Cell Lymphoma (MCL) or Central Nervous System (CNS) lymphoma 2. Significant CNS disorders 3. Active/uncontrolled infections 4. Prior treatment with anti-CD20 x anti-CD3 bispecific antibody 5. Recent cancer therapy or major surgery 6. Drug hypersensitivity 7. Significant comorbidities 8. Pregnancy/breastfeeding NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma

As listed by the trial registrant

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

Diffuse large B cell lymphoma (DLBCL)

How to take part

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

  1. 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 ↗

  2. 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.

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