Phase 2 Open Label Prospective Dose-Ranging Clinical Trial With Escalation and Expansion Cohorts to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Dosing, and Efficacy of RLS-0071 for the Treatment of Hospitalized Patients With Steroid-Refractory Acute Graft-versus-Host Disease
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
Site 0191
RECRUITING
Duarte
Site 1343
RECRUITING
Los Angeles
Georgia
Site 1318
RECRUITING
Atlanta
Missouri
Site 1068
RECRUITING
St Louis
Ohio
Site 1100
RECRUITING
Cincinnati
Site 1382
RECRUITING
Columbus
Other Locations
Germany
Site 3242
RECRUITING
Freiburg Im Breisgau
Spain
Site 3101
RECRUITING
Seville
Contact Information
Primary
Linda Dell, MBA
ldell@realtals.com
201-675-4044
Time Frame
Start Date:2024-08-31
Estimated Completion Date:2025-12
Participants
Target number of participants:66
Treatments
Experimental: RLS-0071Cohort 1
10 mg/kg Q8H RLS-0071 for 7 days
Experimental: RLS-0071 Cohort 2
10 mg/kg Q8H RLS-0071 for 14 days with concurrent ruxolitinib
Experimental: RLS-0071 Cohort 3
20 mg/kg Q8H RLS-0071 for 14 days with concurrent ruxolitinib
Experimental: RLS-0071 Cohort 4
10 mg/kg Q8H RLS-0071 for 7 days and then 10 mg/kg QD RLS-0071 for 7 days with concurrent ruxolitinib
Experimental: RLS-0071 Cohort 5
20 mg/kg Q8H RLS-0071 for 7 days and then 20 mg/kg QD RLS-0071 for 7 days with concurrent ruxolitinib
Experimental: RLS-0071 Expansion Cohort 1
12 participants will receive 10 mg/kg Q8H RLS-0071 for 14 days
Experimental: RLS-0071 Expansion Cohort 2
12 participants will receive 20 mg/kg Q8H RLS-0071 for 14 days