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Brief Title: A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Participants With Aggressive B-cell Non-Hodgkin Lymphomas
Official Title: 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)
Study ID: NCT05685173
Brief Summary: The study is researching an experimental drug called REGN5837 in combination with another experimental drug, odronextamab. 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 for the combination. The study is focused on patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphomas (B-NHLs). 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 your 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)
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope, Duarte, California, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center (BIDMC), Boston, Massachusetts, United States
Rutgers Cancer Institute of New Jersey., New Brunswick, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Laura and Isaac Perlmutter Cancer Center (NYU Cancer Institute (NYUCI), New York, New York, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
University of Texas (UT) - Southwestern Medical Center, Dallas, Texas, United States
Erasmus Medical Center Rotterdam, Rotterdam, Zuid-Holland, Netherlands
Hospital Vall d'Hebron, Barcelona, , Spain
University Hospital & Research Institute - Hospital 12 de Octubre, Madrid, , Spain
Royal Cornwall Hospitals NHS Trust, Truro, Cornwall, United Kingdom
The Christie NHS Foundation Trust, Withington, Manchester, United Kingdom
Name: Clinical Trial Management
Affiliation: Regeneron Pharmaceuticals
Role: STUDY_DIRECTOR