Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies
Completed · Phase 1
Conditions studied: Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
In brief
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.
Key facts
- Study ID
- NCT02290951
- Run by
- Regeneron Pharmaceuticals
- People needed
- 200
- Starts
- 2015-01-09
- Expected to finish
- 2025-08-21
- Last updated by the study team
- 2025-10-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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 Region, France
- Universitatsklinikum Wurzburg — Würzburg, Bavaria, Germany
- Meir Medical Center — Kfar Saba, Central District, Israel
- The Chaim Sheba Medical Center — Tel-Hashomer, Central District, Israel
- Hadassah Medical Center — Jerusalem, Jerusalem, Israel
- Assuta Ashdod University Hospital — Ashdod, Southern District, 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
Full record on ClinicalTrials.gov
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