OncRef

Clinical Trial: NCT02651662

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

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:Regeneron Pharmaceuticals
Information Provided By:Regeneron Pharmaceuticals
Last Update Posted:2026-06-02

Study Overview

Brief 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)

Official Title

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)

Conditions

Relapsed/Refractory Aggressive B-Cell Lymphoma

Intervention / Treatment

  • Drug: cemiplimab
  • Drug: odronextamab

Other Study ID Numbers

  • R1979-ONC-1504
  • 2015-001697-17
  • 2023-508209-25-00
  • 2023
  • 2015

Start Date (Actual)

2016-01-11

Primary Completion Date (Actual)

2026-04-29

Study Completion Date (Actual)

2026-04-29

Enrollment (Actual)

105

Study Type

Interventional

Phase

Phase 1