A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Adult Participants With Aggressive B-cell Non-Hodgkin Lymphomas
NCT ID: NCT05685173
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
91 participants
INTERVENTIONAL
2023-04-12
2029-05-16
Brief Summary
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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.
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)
* To find out how well the study drugs work against relapsed or refractory aggressive B-cell non-Hodgkin lymphomas (B-NHLs)
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Odronextamab and REGN5837
Odronextamab and REGN5837 will be administered by IV infusion using a step-up dosing schedule.
Odronextamab
Odronextamab will be administered by IV infusion
REGN5837
REGN5837 will be administered by IV infusion
Interventions
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Odronextamab
Odronextamab will be administered by IV infusion
REGN5837
REGN5837 will be administered by IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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City of Hope
Duarte, California, United States
University of California Los Angeles (UCLA) Medical Center
Santa Monica, California, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Harvard Medical School - Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
NYU Langone Health Perlmutter Cancer Center
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
UT Southwestern
Dallas, Texas, United States
CHU de Bordeaux
Talence, Nouvelle-Aquitaine, France
Hopital Saint Louis
Paris, Paris, France
Gustave Roussy
Villejuif, Île-de-France Region, France
Erasmus Medical Center Rotterdam
Rotterdam, South Holland, Netherlands
Amsterdam University Medical Centre, location AMC
Amsterdam, , Netherlands
Hospital Vall d'Hebron
Barcelona, Barcelona, Spain
University Hospital and Research Institute
Madrid, Madrid, Spain
Royal Cornwall Hospital NHS Trust
Truro, Cornwall, United Kingdom
Southampton General Hospital
Southampton, Hampshire, United Kingdom
The Christie NHS Foundation Trust
Manchester, Manchester, United Kingdom
Western General Hospital
Edinburgh, Scotland, United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2020-005084-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2022-502137-26-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
R5837-ONC-2019
Identifier Type: -
Identifier Source: org_study_id
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