NCT06343792 · ReAlta Life Sciences, Inc.
Safety, PK, PD, Dosing, and Efficacy of RLS-0071for the Treatment of Hospitalized Patients With Steroid-Refractory Acute Graft-versus-Host Disease
(AURORA)
What this study is about
This study is a Open Label forward-looking Dose-Ranging Escalation and Expansion Trial to Evaluate Safety, Tolerability, how the drug moves through the body, how the drug affects the body, Dosing, and effectiveness of RLS-0071 for the secondary treatment of acute Graft-versus-Host Disease (aGvHD) in hospitalized patients who are steroid-refractory.
View original scientific description
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.
Interventions
DRUG
RLS-0071
RLS-0071 will be administered for 7 or 14 days according to the assigned dose group.
Primary outcome measures
Number of participants with treatment-related adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: Day 1 to Day 180
Overall Response Rate (ORR) of RLS-0071
Time frame: Day 1 to Day 28
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Endoscopic and biopsy testing (if performed) that definitively rules out lower GI
Where
- Duarte, California
- Los Angeles, California
- Atlanta, Georgia
- St Louis, Missouri
- Cincinnati, Ohio
- Columbus, Ohio
Collaborators
CTI Clinical Trial and Consulting Services
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 24, 2025 · Source of record for eligibility and locations