Actively Recruiting
A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Adult Participants With Aggressive B-cell Non-Hodgkin Lymphomas
Led by Regeneron Pharmaceuticals · Updated on 2026-05-04
107
Participants Needed
20
Research Sites
351 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Adult Participants With Aggressive B-cell Non-Hodgkin Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented CD20-positive aggressive B-cell Non-Hodgkin Lymphoma with disease progression after at least 2 prior systemic therapies including an anti-CD20 antibody and an alkylating agent
- Measurable disease by cross-sectional imaging
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate bone marrow, kidney, and liver function
- Availability of tumor tissue for central laboratory submission; archival tissue is allowed
- Willingness to undergo tumor biopsies during dose expansion if safely accessible
You will not qualify if you...
- Prior allogeneic stem cell or solid organ transplantation
- Previous treatment with anti-CD20 x anti-CD3 bispecific antibodies such as odronextamab
- Diagnosis of Mantle Cell Lymphoma
- Primary Central Nervous System lymphoma or known CNS involvement by non-primary CNS lymphoma
- Systemic anti-lymphoma therapy within 5 half-lives or 14 days before first study drug dose
- Radiotherapy within 14 days before first study drug dose
- Continuous systemic corticosteroids over 10 mg prednisone or equivalent within 72 hours before odronextamab start
- Presence of co-morbid conditions as defined in the protocol
- Active infections as defined in the protocol
- Known allergy or hypersensitivity to allopurinol and rasburicase
- Other protocol-defined criteria apply
AI-Screening
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Trial Site Locations
Total: 20 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
University of California Los Angeles (UCLA) Medical Center
Santa Monica, California, United States, 90404
Actively Recruiting
3
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
Actively Recruiting
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
5
Harvard Medical School - Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
7
NYU Langone Health Perlmutter Cancer Center
New York, New York, United States, 10016
Actively Recruiting
8
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
9
UT Southwestern
Dallas, Texas, United States, 75390
Actively Recruiting
10
CHU de Bordeaux
Talence, New Aquitaine, France, 33404
Actively Recruiting
11
Hopital Saint Louis
Paris, France, 75010
Actively Recruiting
12
Gustave Roussy
Villejuif, Île-de-France Region, France, 94800
Actively Recruiting
13
Erasmus Medical Center Rotterdam
Rotterdam, South Holland, Netherlands, 3015
Actively Recruiting
14
Amsterdam University Medical Centre, location AMC
Amsterdam, Netherlands, 1100AZ
Actively Recruiting
15
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
16
University Hospital and Research Institute
Madrid, Spain, 28041
Actively Recruiting
17
Royal Cornwall Hospitals NHS Trust
Truro, Cornwall, United Kingdom, TR1 3LJ
Actively Recruiting
18
Southampton General Hospital
Southampton, Hampshire, United Kingdom, SO16 6YD
Actively Recruiting
19
Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 2XU
Actively Recruiting
20
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
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Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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