Featured Trial
Our review committee has reviewed this trial and it meets our criteria for going above and beyond. Learn more about featured trials.
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.
In this trial, you’ll be placed in 1 of 2 groups:
Ruxolitinib is a small molecule inhibitor that blocks JAK1 and JAK2 in certain cells.
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.
Locations
Study Site 1091RECRUITING
Duarte, California
Study Site 1433RECRUITING
Los Angeles, California
Study Site 1068RECRUITING
Saint Louis, Missouri
Sponsors
collaborator: CTI Clinical Trial and Consulting Services, lead: ReAlta Life Sciences, Inc.
