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A drug, RLS-0071 , alone or with ruxolitinib, to treat acute graft-versus-host disease (GVHD) that has not gotten better with treatment (refractory) in children and adults

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Phase 2

3 Locations

NCT06343792

Clinical Trial Goal


To find out:
  • The highest dose of RLS-0071 that’s safe to give with ruxolitinib
  • If the combination of RLS-0071, alone or with ruxolitinib, is safe and works well to treat acute GVHD that is refractory to steroids 

You may be able to join this trial if you:


  • Are 12 years old or older
  • Are in the hospital with acute GVHD that is steroid-refractory
  • The acute GVHD is stage 2, 3, or 4
  • Have not had an an allogeneic (cells from a donor) blood or marrow transplant (BMT) more than 1 time
  • Have not been treated with ruxolitinib
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


RLS-0071 is an inflammatory inhibitor peptide that doctors think will treat inflammatory disease. 
Ruxolitinib is a small molecule inhibitor that blocks JAK1 and JAK2 in certain cells. This means the drug tries to stop certain T-cell signals that can lead to tissue damage.

In this trial, you’ll be placed in 1 of 2 groups:
  • Group 1 – RLS-0071
  • Group 2 – RLS-0071 plus ruxolitinib 

You'll get: 
  • RLS-0071 – Given as intravenous (IV) infusions 3 times each day for 1 or 2 weeks. The dose you'll get depends on when you start the trial and how safe it has been
  • Ruxolitinib –  Group 2 only -  A pill that you take by mouth

You may continue treatment for up to 2 weeks. You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 6 months.

The Food and Drug Administration (FDA) has approved ruxolitinib to treat acute GVHD. The FDA has not yet approved  RLS-0071. 

Contacts


Linda Dell, MBA, 201-675-4044, ldell@realtals.com

Locations


Study Site 1091RECRUITING

Duarte, California

Study Site 1433RECRUITING

Los Angeles, California

Study Site 1068RECRUITING

Saint Louis, Missouri

ClinicalTrials.gov record


NCT06343792. First posted on Apr 3

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