This study is a Open Label Prospective Dose-Ranging Escalation and Expansion Trial to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Dosing, and Efficacy of RLS-0071 for the secondary treatment of acute Graft-versus-Host Disease (aGvHD) in hospitalized patients who are steroid-refractory.
Male or female adults or adolescents (>12 years old).
Hospitalized with steroid-refractory aGvHD (grade II-IV) after allo-HSCT
Anticipated hospital length-of-stay of at least 1 week from the time of RLS-0071 initiation.
No plans to add additional GvHD treatment medications or to add, dose-adjust, or discontinue GvHD prophylactic medications during the 7-days of RLS-0071 treatment.
Has received more than 1 allo-HSCT
Current, previous, or planned use of any systemic treatment in addition to or other than corticosteroids or ruxolitinib for aGvHD
Previous failure of ruxolitinib treatment
Uncontrolled GI infection
Sequential
RLS-0071
DrugRLS-0071 will be administered for 7 or 14 days according to the assigned dose group.
7
Treatment groupsSee each treatment group below.
Number of participants with treatment-related adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Overall Response Rate (ORR) of RLS-0071
Incidence of refractoriness (to RLS-0071 +/- ruxolitinib)
Overall corticosteroid use
Initiation of additional or alternative treatment(s) for aGvHD (including an increase in steroid dose to >2 mg/kg methylprednisolone equivalent)
Change or shift in Stage for lower GI aGvHD, liver aGvHD, skin aGvHD, or upper GI aGvHD from baseline based on MAGIC Criteria
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ReAlta Life Sciences, Inc.
Lead sponsor
CTI Clinical Trial and Consulting Services
Collaborator
