Non Hodgkin Lymphoma Clinical Trial

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

Summary

The study is researching an experimental drug called REGN5837 in combination with another experimental drug, odronextamab. The aim of the study is to see how safe and tolerable the study drugs are, and to define the recommended dose for phase 2 for the combination.

The study is focused on patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphomas (B-NHLs).

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 your 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)
To find out how well the study drugs work against relapsed or refractory aggressive B-cell non-Hodgkin lymphomas (B-NHLs)

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

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.
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
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:

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
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
Standard radiotherapy within 14 days of first administration of study drug.
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

NOTE: Other protocol defined inclusion / exclusion criteria apply

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

91

Study ID:

NCT05685173

Recruitment Status:

Recruiting

Sponsor:

Regeneron Pharmaceuticals

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 10 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States
Norton Cancer Institute
Louisville Kentucky, 40241, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston Massachusetts, 02215, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States
Laura and Isaac Perlmutter Cancer Center (NYU Cancer Institute (NYUCI)
New York New York, 10016, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
University of Texas (UT) - Southwestern Medical Center
Dallas Texas, 75390, United States
Royal Cornwall Hospitals NHS Trust
Truro Cornwall, TR1 3, United Kingdom
The Christie NHS Foundation Trust
Withington Manchester, M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

91

Study ID:

NCT05685173

Recruitment Status:

Recruiting

Sponsor:


Regeneron Pharmaceuticals

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.