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A drug, REGN5837, in combination with odronextamab, to treat B-cell non-Hodgkin lymphoma (NHL) that has come back (relapsed) or has not gotten better with treatment (refractory)

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18 and older

Phase 1

9 Locations

NCT05685173

Clinical Trial Goal


To find out:
  • The highest dose of REGN5837 that’s safe to give with odronextamab 
  • If the combination of REGN5837 and odronextamab is safe and works well to treat B-cell NHL that has relapsed or is refractory

You may be able to join this trial if you:


  • Are 18 years old or older
  • Have B-cell NHL that has relapsed or is refractory. Some examples include:
    • Burkitt lymphoma 
    • Chronic lymphocytic leukemia/small-cell lymphocytic lymphoma (CLL/SLL)
    • Diffuse large B-cell lymphoma (DLBCL)
    • Follicular lymphoma
    • Lymphoblastic lymphoma 
    • Marginal zone lymphoma (MZL)
    • Primary Mediastinal large B-cell lymphoma (PMBCL)
    • Waldenström macroglobulinemia 
  • Do not have lymphoma in your brain or spinal cord
  • Do not have mantle cell lymphoma (MCL)
  • Have not been treated with bispecific antibody drugs that target CD3 or CD20. Your doctor can tell you this
  • Have not had an allogeneic (cells from a donor) blood or marrow transplant (BMT)
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


Odronextamab is a bispecific antibody that targets CD3 and CD20 on certain cells. 
REGN5837 is a bispecific antibody that targets CD22 and CD28 on certain cells. 
 
You’ll get treatment in cycles that last 3 weeks. In each cycle, you'll get:
  • Odronextamab – Given as intravenous (IV) infusions
  • REGN5837 - Given as IV infusions. The dose you'll get depends on when you start the trial and how safe it has been

You may continue treatment for as long as the clinical trial doctors think it’s best for your health. You'll have biopsies and/or scans to see how well the treatment is working. The clinical trial doctors will check your health for about 5 years.

The Food and Drug Administration (FDA) has not yet approved odronextamab or REGN5837. 

Contacts


Clinical Trials Administrator, 844-734-6643, clinicaltrials@regeneron.com

Locations

City of HopeRECRUITING

Duarte, California

University of California Los Angeles (UCLA) Medical CenterRECRUITING

Santa Monica, California

Norton Cancer InstituteRECRUITING

Louisville, Kentucky

Harvard Medical School - Beth Israel Deaconess Medical CenterRECRUITING

Boston, Massachusetts

Massachusetts General HospitalRECRUITING

Boston, Massachusetts

Rutgers Cancer Institute of New JerseyRECRUITING

New Brunswick, New Jersey

Icahn School of Medicine at Mount SinaiRECRUITING

New York, New York

NYU Langone Health Perlmutter Cancer CenterRECRUITING

New York, New York

UT SouthwesternRECRUITING

Dallas, Texas

ClinicalTrials.gov record


NCT05685173. First posted on 1/13/23

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