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
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Treatment groupsSee each treatment group below.
ReAlta Life Sciences, Inc.
Lead sponsor
CTI Clinical Trial and Consulting Services
Collaborator