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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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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