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RLS-0071 for Graft-versus-Host Disease (AURORA Trial)
Phase 2
Recruiting
Research Sponsored by ReAlta Life Sciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hospitalized with steroid-refractory aGvHD (grade II-IV) after allo-HSCT
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
"This trial will test the safety, effectiveness, and best dose of RLS-0071 as a secondary treatment for acute Graft-versus-Host Disease in hospitalized patients who have not responded to steroids
Who is the study for?
This trial is for hospitalized adults and adolescents over 12 years old, weighing between 40-140 kg, with grade II-IV acute Graft-versus-Host Disease that hasn't improved with steroids. Participants must have recovered neutrophils after a stem-cell transplant and expect to stay in the hospital for at least one week.
What is being tested?
The study tests RLS-0071's safety and effectiveness as a secondary treatment for steroid-refractory acute Graft-versus-Host Disease. It involves varying doses of RLS-0071 to find the right balance between efficacy and tolerability.
What are the potential side effects?
Possible side effects of RLS-0071 are not detailed here but typically include reactions related to immune system activation or suppression, which could affect various organs and overall health.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am in the hospital for aGvHD that didn't respond to steroids after a stem cell transplant.
Select...
My neutrophil levels have recovered post-transplant without extra help.
Select...
My weight is between 40 kg and 140 kg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
8Treatment groups
Experimental Treatment
Group I: RLS-0071Cohort 1Experimental Treatment1 Intervention
10 mg/kg Q8H RLS-0071 for 7 days
Group II: RLS-0071 Expansion Cohort 2Experimental Treatment1 Intervention
12 participants will receive 10 or 40 mg/kg Q8H RLS-0071 for 7 or 14 days
Group III: RLS-0071 Expansion Cohort 1Experimental Treatment1 Intervention
12 participants will receive 10 or 40 mg/kg Q8H RLS-0071 for 7 or 14 days
Group IV: RLS-0071 Cohort 6Experimental Treatment1 Intervention
40 mg/kg Q8H RLS-0071 for 7 days and then 40 mg/kg QD RLS-0071 for 7 days with concurrent ruxolitinib
Group V: RLS-0071 Cohort 5Experimental Treatment1 Intervention
10 mg/kg Q8H RLS-0071 for 7 days and then 10 mg/kg QD RLS-0071 for 7 days with concurrent ruxolitinib
Group VI: RLS-0071 Cohort 4Experimental Treatment1 Intervention
40 mg/kg Q8H RLS-0071 for 14 days with concurrent ruxolitinib
Group VII: RLS-0071 Cohort 3Experimental Treatment1 Intervention
10 mg/kg Q8H RLS-0071 for 14 days with concurrent ruxolitinib
Group VIII: RLS-0071 Cohort 2Experimental Treatment1 Intervention
40 mg/kg Q8H RLS-0071 for 7 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RLS-0071
2021
Completed Phase 1
~60
Find a Location
Who is running the clinical trial?
ReAlta Life Sciences, Inc.Lead Sponsor
5 Previous Clinical Trials
152 Total Patients Enrolled
CTI Clinical Trial and Consulting ServicesOTHER
35 Previous Clinical Trials
3,724 Total Patients Enrolled