NCT02290951

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 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.

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Interventions

Odronextamab multiple dose levelsDRUG
Administered by intravenous (IV) infusion
Odronextamab multiple dose levelsDRUG
Administered by subcutaneous (SC) injection

Study Locations

FacilityCityStateCountry
University of California, IrvineOrangeCaliforniaUnited States
Stanford UniversityStanfordCaliforniaUnited States
H. Lee Moffitt Cancer CenterTampaFloridaUnited States
Massachusetts General HospitalBostonMassachusettsUnited States
Beth Israel Deaconess Medical CenterBostonMassachusettsUnited States
Dana Farber Cancer Institute (Massachusetts General Hospital and Beth Israel)BostonMassachusettsUnited States
Mayo ClinicRochesterMinnesotaUnited States
Rutgers Cancer Institute of New JerseyNew BrunswickNew JerseyUnited States
Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUnited States
Weill Cornell Medical CollegeNew YorkNew YorkUnited States
Centre Henri BecquerelRouenHaute-NormandieFrance
CHU Hôpital Lyon SudLyonFrance
Institut Gustave RoussyVillejuifÎle-de-France RegionFrance
Universitatsklinikum WurzburgWürzburgBavariaGermany
Meir Medical CenterKfar SabaCentral DistrictIsrael
The Chaim Sheba Medical CenterTel-HashomerCentral DistrictIsrael
Hadassah Medical CenterJerusalemJerusalemIsrael
Assuta Ashdod University HospitalAshdodSouthern DistrictIsrael
Rambam Health Care Campus - Hematology and Bone Marrow Transplantation InstituteHaifaIsrael
Lady Davis Carmel Medical CenterHaifaIsrael
Royal Cornwall Hospitals NHS TrustTruroCornwallUnited Kingdom
The Christie NHS Foundation TrustManchesterUnited Kingdom

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026