NCT05685173

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

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)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 91 (estimated)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Conditions

• B-cell Non-Hodgkins Lymphoma (B-NHL)

Interventions

Type	Name	Description
DRUG	Odronextamab	Odronextamab will be administered by IV infusion
DRUG	REGN5837	REGN5837 will be administered by IV infusion

Timeline

• Start date: 2023-04-12
• Primary completion: 2027-06-02
• Completion: 2029-05-16
• First posted: 2023-01-13
• Last updated: 2026-03-30

Locations

20 sites across 5 countries: United States, France, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study