NCT02651662

A Study to Learn How Safe and Tolerable Odronextamab and Cemiplimab Are in Adult Patients With B-cell Malignancies

A Phase 1 Study to Assess Safety and Tolerability of Odronextamab (REGN1979) an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, and Cemiplimab (REGN2810), an Anti-Programmed Death-1 Monoclonal Antibody in Patients With B-Cell Malignancies (CLIO-1)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is researching a combination of 2 experimental drugs, referred to as "study drugs", called odronextamab (also known as REGN1979) and cemiplimab (also known as REGN2810). The study is focused on patients who have relapse/refractory aggressive B-cell lymphoma. The aim of the study is to see how safe and tolerable the study drugs are, and to define the recommended dose regimen for the combination with odronextamab. This study is also looking at several other research questions, including: * What side effects may happen from taking the study drugs * How effective the study drugs are against the disease * How much study drug is in the blood at different times * Whether the body makes substances or protein called antibodies against the study drugs (that could make the drugs less effective or could lead to side effects)

Conditions

• Relapsed/Refractory Aggressive B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	cemiplimab	Administration via intravenous (IV) infusion. The dose(s) received will be according to dose level (DL) cohort assignment, as described in the protocol.
DRUG	odronextamab	Administration IV infusion. The dose(s) received will be according to DL cohort assignment, as described in the protocol.

Timeline

• Start date: 2016-01-11
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2016-01-11
• Last updated: 2026-02-02

Locations

30 sites across 6 countries: United States, Austria, Germany, Israel, Poland, Spain

Regulatory

• FDA-regulated drug study