Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT02651662
PHASE1

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

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

105

Start Date

2016-01-11

Completion Date

2026-05-31

Last Updated

2026-02-02

Healthy Volunteers

No

Interventions

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.

Locations (30)

Johns Hopkins University

Baltimore, Maryland, United States

Dana Farber/Harvard Cancer Center - PO box 849168

Boston, Massachusetts, United States

Harvard Medical School - Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Cancer & Hematology Centers of Western Michigan

Grand Rapids, Michigan, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Uniklinikum Salzburg (LKH) Universitatsklinik fur Innere Medizin III

Salzburg, Austria

Medical University Vienna

Vienna, Austria

University Hospital Frankfurt

Frankfurt am Main, Germany

Universitatsklinikum Jena

Jena, Germany

Universitatsklinikum Schleswig-Holstein, Campus Kiel

Kiel, Germany

Soroka

Beersheba, Israel

Hadassah Medical Center

Jerusalem, Israel

Chaim Sheba Medical Center

Ramat Gan, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Pratia MCM Krakow

Krakow, Malopolska, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Pomeranian Voivodeship, Poland

Pratia Onkologia Katowice

Katowice, Poland

Copernicus Memorial Hospital

Lodz, Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Warszawa

Warsaw, Poland

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Madrid, Spain

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Institut Catala dOncologia (ICO Hospitalet)

Barcelona, Spain

MD Anderson Cancer Center- Madrid

Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Clinico Universitario de Salamanca

Salamanca, Spain