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A Study to Learn How Safe and Tolerable Odronextamab and Cemiplimab Are in Adult Patients With B-cell Malignancies
Sponsor: Regeneron Pharmaceuticals
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
cemiplimab
Administration via intravenous (IV) infusion. The dose(s) received will be according to dose level (DL) cohort assignment, as described in the protocol.
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