Spots Global Cancer Trial Database for Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies
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Trial Identification
Brief Title: Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies
Official Title: An Open-Label, Multi-Center Phase 1 Study to Investigate the Safety and Tolerability of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients With CD20+ B-Cell Malignancies Previously Treated With CD20-Directed Antibody Therapy (ELM-1)
Study ID: NCT02290951
Study Description
Brief Summary: This study has two parts with distinct study objectives and study design. In part A, odronextamab is studied as an intravenous (IV) administration with a dose escalation and a dose expansion phase for B-NHL and CLL. The dose escalation phase for B-NHL and the CLL study are closed at the time of protocol amendment 17. In part B, odronextamab is studied as a subcutaneous (SC) administration with a dose finding and a dose expansion phase for B-NHL.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California, Irvine, Orange, California, United States
Stanford University, Stanford, California, United States
H. Lee Moffitt Cancer Center, Tampa, Florida, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana Farber Cancer Institute (Massachusetts General Hospital and Beth Israel), Boston, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Weill Cornell Medical College, New York, New York, United States
Centre Henri Becquerel, Rouen, Haute-Normandie, France
CHU Hôpital Lyon Sud, Lyon, , France
Institut Gustave Roussy, Villejuif, Île-de-France, France
Universitatsklinikum Wurzburg, Wurzburg, Bayern, Germany
Assuta Ashdod University Hospital, Ashdod, HaDarom, Israel
Meir Medical Center, Kfar Saba, HaMerkaz, Israel
The Chaim Sheba Medical Center, Tel-Hashomer, HaMerkaz, Israel
Hadassah Medical Center, Jerusalem, Yerushalayim, Israel
Rambam Health Care Campus - Hematology and Bone Marrow Transplantation Institute, Haifa, , Israel
Lady Davis Carmel Medical Center, Haifa, , Israel
Royal Cornwall Hospitals NHS Trust, Truro, Cornwall, United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Contact Details
Name: Clinical Trial Management
Affiliation: Regeneron Pharmaceuticals
Role: STUDY_DIRECTOR
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