Safety, PK, PD, Dosing, and Efficacy of RLS-0071for the Treatment of Hospitalized Patients With Steroid-Refractory Acute Graft-versus-Host Disease
12 Years and older, Male and Female
RLS-0071-203 (primary)
NCI-2024-05325
Summary
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.
Eligibility
- 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.
- Neutrophil recovery following the stem-cell transplantation, defined as blood neutrophil count >500/mL for at least 3 consecutive measurements and not supported by growth factor supplementation
- Weight >40 kg and = 140 kg at screening.
Treatment Sites in Georgia
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-851-8523
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