Safety, PK, PD, Dosing, and Efficacy of RLS-0071for the Treatment of Hospitalized Patients With Steroid-Refractory Acute Graft-versus-Host Disease (AURORA)

November 18, 2025 updated by: ReAlta Life Sciences, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Freiburg im Breisgau, Germany, 79106
        • Recruiting
        • Site 3242
  • Spain
      • Madrid, Spain
        • Recruiting
        • Site 3360
      • Salamanca, Spain
        • Recruiting
        • Site 3227
      • Seville, Spain
        • Recruiting
        • Site 3101
    • SE
      • Seville, SE, Spain, 41013
        • Recruiting
        • Site 3101
  • United States
    • California
      • Duarte, California, United States, 91010
        • Active, not recruiting
        • Site 1091
      • Los Angeles, California, United States, 90095
        • Active, not recruiting
        • Site 1343
    • Georgia
      • Atlanta, Georgia, United States, 30041
        • Active, not recruiting
        • Site 1318
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Active, not recruiting
        • Site 1068
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Active, not recruiting
        • Site 1100
      • Columbus, Ohio, United States, 43210
        • Active, not recruiting
        • Site 1382

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 aGvHD
  • Chronic GvHD
  • Participants with evidence of relapsed primary disease, or participants who have been treated for relapse after the allo-HSCT was performed.
  • Unresolved toxicity or complications (other than aGvHD) due to the allo-HSCT
  • Any corticosteroid therapy for indications other than aGvHD at doses of methylprednisolone or equivalent >1 mg/kg per day within 7 days of enrollment.
  • Severe organ dysfunction unrelated to underlying aGvHD
  • Known hypersensitivity, allergy, or anaphylactic reaction to polyethylene glycol (PEG)
  • Significant liver disease that is unrelated to GvHD
  • Severe kidney disease
  • Currently breast feeding.
  • Known pregnancy, a positive pregnancy test at screening, or lactation for WOCBP.
  • Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or human immunodeficiency virus (HIV)-1 or HIV-2.
  • Active sepsis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: RLS-0071Cohort 1
10 mg/kg Q8H RLS-0071 for 7 days
Drug: RLS-0071
RLS-0071 will be administered for 7 or 14 days according to the assigned dose group.
Experimental: RLS-0071 Cohort 2
10 mg/kg Q8H RLS-0071 for 14 days with concurrent ruxolitinib
Drug: RLS-0071
RLS-0071 will be administered for 7 or 14 days according to the assigned dose group.
Experimental: RLS-0071 Cohort 3
20 mg/kg Q8H RLS-0071 for 14 days with concurrent ruxolitinib
Drug: RLS-0071
RLS-0071 will be administered for 7 or 14 days according to the assigned dose group.
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
Drug: RLS-0071
RLS-0071 will be administered for 7 or 14 days according to the assigned dose group.
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
Drug: RLS-0071
RLS-0071 will be administered for 7 or 14 days according to the assigned dose group.
Experimental: RLS-0071 Expansion Cohort 1
12 participants will receive 10 mg/kg Q8H RLS-0071 for 14 days
Drug: RLS-0071
RLS-0071 will be administered for 7 or 14 days according to the assigned dose group.
Experimental: RLS-0071 Expansion Cohort 2
12 participants will receive 20 mg/kg Q8H RLS-0071 for 14 days
Drug: RLS-0071
RLS-0071 will be administered for 7 or 14 days according to the assigned dose group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of participants with treatment-related adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time Frame: Day 1 to Day 180
Day 1 to Day 180
Overall Response Rate (ORR) of RLS-0071
Time Frame: Day 1 to Day 28
Day 1 to Day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidence of refractoriness (to RLS-0071 +/- ruxolitinib)
Time Frame: Days 7, 14, 28, 56, and 180
Days 7, 14, 28, 56, and 180
Overall corticosteroid use
Time Frame: Days 7, 14, 28, 56, and 180
Days 7, 14, 28, 56, and 180
Initiation of additional or alternative treatment(s) for aGvHD (including an increase in steroid dose to >2 mg/kg methylprednisolone equivalent)
Time Frame: Day 1 - Day 180
Day 1 - Day 180
Change or shift in Stage for lower GI aGvHD, liver aGvHD, skin aGvHD, or upper GI aGvHD from baseline based on MAGIC Criteria
Time Frame: Days 7, 14, 28, 56, and 180
Days 7, 14, 28, 56, and 180
Attainment of Stage 0 or 1 lower GI aGvHD, liver aGvHD, skin aGvHD, or upper GI aGvHD
Time Frame: Days 7, 14, 28, 56, and 180
Days 7, 14, 28, 56, and 180
Change or shift in overall Grade of aGvHD
Time Frame: Day 0 - Days 7, 14, 28, 56, and 180.
Day 0 - Days 7, 14, 28, 56, and 180.
Overall survival
Time Frame: Day 1 - Day 180
Day 1 - Day 180
Non-relapse mortality
Time Frame: Day 1 - Day 180
Day 1 - Day 180
Duration of hospital stay
Time Frame: Day 1 - Day 180
Day 1 - Day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ReAlta Life Sciences, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CTI Clinical Trial and Consulting Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RLS-0071-203

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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