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A drug, ONM-501,  in combination with cemiplimab, to treat lymphoma that has come back (relapsed) or not gotten better with treatment (refractory)

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18 and older

Phase 1

9 Locations

NCT06022029

Clinical Trial Goal


To find out:
  • The highest dose of ONM-501 that's safe to give with cemiplimab
  • If the combination of ONM-501 and cemiplimab is safe and works well to treat lymphoma that has relapsed or is refractory

You may be able to join this trial if you:


  • Are 18 years or older
  • Have lymphoma that has relapsed or is refractory
  • Do not have lymphoma in your brain or spinal cord
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


Cemiplimab is a monoclonal antibody that targets PD-1/PD-L1 in certain cells. 
ONM-501 is a dual-activating polyvalent STING agonist that doctors believe will find and attack cancer cells. 

You’ll get treatment in cycles that last 3 weeks. In each cycle, you'll get: 
  • Cemiplimab – Given as intravenous (IV) infusion. The dose you'll get depends on when you start the trial and how safe it has been
  • ONM-501 –  Given as an injection. The dose you'll get depends on when you start the trial and how safe it has been

You'll have scans to see how well the treatment is working. The clinical trial doctors will check your health for up to 2 years.

The Food and Drug Administration (FDA) has not yet approved ONM-501. 

Contacts


Trials@OncoNanoMed.com, (682) 285-1411, trials@onconanomed.com

Locations

California Research InstituteACTIVE_NOT_RECRUITING

Los Angeles, California

BRCR GlobalWITHDRAWN

Tamarac, Florida

Ohio State UniversityACTIVE_NOT_RECRUITING

Columbus, Ohio

Gabrail Cancer Center ResearchCOMPLETED

Canton, Ohio

Allegheny Health NetworkCOMPLETED

Pittsburgh, Pennsylvania

UPMC Hillman Cancer CenterCOMPLETED

Pittsburgh, Pennsylvania

MD Anderson Cancer CenterACTIVE_NOT_RECRUITING

Houston, Texas

University of Texas Southwestern Medical CenterACTIVE_NOT_RECRUITING

Dallas, Texas

Virginia Cancer Specialists, PCACTIVE_NOT_RECRUITING

Fairfax, Virginia

ClinicalTrials.gov record


NCT06022029. First posted on 9/1/23

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