Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies

Part of paid clinical trials in Orange, California.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT02290951
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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 Dates

Start date
Jan 9, 2015
Status verified
Aug 2025
Primary completion
Aug 21, 2025
Completion
Aug 21, 2025

Study Design

Enrollment
200 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A
    DLBCL post CAR-T
  • Experimental: 1N Part B
    FL
  • Experimental: 2N Part B
    DLBCL

Primary Outcome Measure

Safety/overall frequency of adverse events (AEs) [ Time Frame: Up to 24 months ]

Locations (10)

FacilityCityStateZIPSite coordinators
University of California, IrvineOrangeCalifornia92868-
Stanford UniversityStanfordCalifornia94305-
H. Lee Moffitt Cancer CenterTampaFlorida33612-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Cancer Institute (Massachusetts General Hospital and Beth Israel)BostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Mayo ClinicRochesterMinnesota55905-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Weill Cornell Medical CollegeNew YorkNew York10065-

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