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A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Adult Participants With Aggressive B-cell Non-Hodgkin Lymphomas
NCT05685173 · Regeneron Pharmaceuticals
In plain English
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Official title
A Phase 1 Study to Assess Safety and Tolerability of REGN5837, an Anti-CD22 x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination With Odronextamab, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients With Aggressive B-Cell Non-Hodgkin Lymphomas (ATHENA-1)
About this study
The study is researching an experimental drug called REGN5837 in combination with another experimental drug, odronextamab (called "study drugs").
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)
Eligibility criteria
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
Study design
Enrollment target: 91 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-04-12
Estimated completion: 2029-05-16
Last updated: 2026-03-30
Interventions
Drug: OdronextamabDrug: REGN5837
Primary outcomes
- • Incidence of Dose Limiting Toxicities (DLTs) of REGN5837 in combination with odronextamab (From Cycle 2, Day 15 to Cycle 4, Day 7 (each induction cycle is 21 days))
- • Incidence of treatment-emergent adverse events (TEAEs) of REGN5837 in combination with odronextamab (Up to approximatively 5 years)
- • Severity of TEAEs of REGN5837 in combination with odronextamab (Up to approximatively 5 years)
Sponsor
Regeneron Pharmaceuticals · industry
Contacts & investigators
ContactClinical Trials Administrator · contact · clinicaltrials@regeneron.com · 844-734-6643
InvestigatorClinical Trial Management · study_director, Regeneron Pharmaceuticals
All locations (20)
City of HopeRecruiting
Duarte, California, United States
University of California Los Angeles (UCLA) Medical CenterRecruiting
Santa Monica, California, United States
Norton Cancer InstituteRecruiting
Louisville, Kentucky, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Harvard Medical School - Beth Israel Deaconess Medical CenterRecruiting
Boston, Massachusetts, United States
Rutgers Cancer Institute of New JerseyRecruiting
New Brunswick, New Jersey, United States
NYU Langone Health Perlmutter Cancer CenterRecruiting
New York, New York, United States
Icahn School of Medicine at Mount SinaiRecruiting
New York, New York, United States
UT SouthwesternRecruiting
Dallas, Texas, United States
CHU de BordeauxRecruiting
Talence, New Aquitaine, France
Hopital Saint LouisRecruiting
Paris, France
Gustave RoussyRecruiting
Villejuif, Île-de-France Region, France
Erasmus Medical Center RotterdamRecruiting
Rotterdam, South Holland, Netherlands
Amsterdam University Medical Centre, location AMCRecruiting
Amsterdam, Netherlands
Hospital Vall d'HebronRecruiting
Barcelona, Spain
University Hospital and Research InstituteRecruiting
Madrid, Spain
Royal Cornwall Hospitals NHS TrustRecruiting
Truro, Cornwall, United Kingdom
Southampton General HospitalRecruiting
Southampton, Hampshire, United Kingdom
Western General HospitalRecruiting
Edinburgh, Scotland, United Kingdom
The Christie NHS Foundation TrustRecruiting
Manchester, United Kingdom