AzTrials
AzTrials

Steroid Refractory GVHDPhase 2AURORANCT06343792

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

A Phase 2 study testing RLS-0071 in people with Steroid Refractory GVHD, run by ReAlta Life Sciences, Inc. at 11 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Steroid Refractory GVHD
What is being tested?
RLS-0071
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
11 sitesin 3 countries
Study dates
31 Aug 2024to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

11 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Linda Dell, MBA contact

201-675-4044

ldell@realtals.com

11 sites in 3 countries

United States6 sites

  • Site 1318

    Atlanta, Georgia, 30041

    Active, not recruiting

  • Site 1100

    Cincinnati, Ohio, 45229

    Active, not recruiting

  • Site 1382

    Columbus, Ohio, 43210

    Active, not recruiting

  • Site 1091

    Duarte, California, 91010

    Active, not recruiting

  • Site 1343

    Los Angeles, California, 90095

    Active, not recruiting

  • Site 1068

    St Louis, Missouri, 63110

    Active, not recruiting

Other trials in United States

Spain4 sites, 4 recruiting

  • Site 3360

    Madrid

    Recruiting

  • Site 3227

    Salamanca

    Recruiting

  • Site 3101

    Seville, SE, 41013

    Recruiting

  • Site 3101

    Seville

    Recruiting

Other trials in Spain

Germany1 site, 1 recruiting

  • Site 3242

    Freiburg im Breisgau, 79106

    Recruiting

Other trials in Germany

About this study

Official title: 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.

Being tested
RLS-0071

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RLS-0071Drug

    RLS-0071 will be administered for 7 or 14 days according to the assigned dose group.

Study groups in NCT06343792
Study groupRoleWhat they receive
RLS-0071Cohort 1Experimental10 mg/kg Q8H RLS-0071 for 7 days
Receives: Drug: RLS-0071
RLS-0071 Cohort 2Experimental10 mg/kg Q8H RLS-0071 for 14 days with concurrent ruxolitinib
Receives: Drug: RLS-0071
RLS-0071 Cohort 3Experimental20 mg/kg Q8H RLS-0071 for 14 days with concurrent ruxolitinib
Receives: Drug: RLS-0071
RLS-0071 Cohort 4Experimental10 mg/kg Q8H RLS-0071 for 7 days and then 10 mg/kg QD RLS-0071 for 7 days with concurrent ruxolitinib
Receives: Drug: RLS-0071
RLS-0071 Cohort 5Experimental20 mg/kg Q8H RLS-0071 for 7 days and then 20 mg/kg QD RLS-0071 for 7 days with concurrent ruxolitinib
Receives: Drug: RLS-0071
RLS-0071 Expansion Cohort 1Experimental12 participants will receive 10 mg/kg Q8H RLS-0071 for 14 days
Receives: Drug: RLS-0071
RLS-0071 Expansion Cohort 2Experimental12 participants will receive 20 mg/kg Q8H RLS-0071 for 14 days
Receives: Drug: RLS-0071

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with treatment-related adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

    Measured: Day 1 to Day 180

  2. Overall Response Rate (ORR) of RLS-0071

    Measured: Day 1 to Day 28

Secondary outcomes (9)

  1. Incidence of refractoriness (to RLS-0071 +/- ruxolitinib)

    Measured: Days 7, 14, 28, 56, and 180

  2. Overall corticosteroid use

    Measured: Days 7, 14, 28, 56, and 180

  3. Initiation of additional or alternative treatment(s) for aGvHD (including an increase in steroid dose to >2 mg/kg methylprednisolone equivalent)

    Measured: Day 1 - Day 180

  4. Change or shift in Stage for lower GI aGvHD, liver aGvHD, skin aGvHD, or upper GI aGvHD from baseline based on MAGIC Criteria

    Measured: Days 7, 14, 28, 56, and 180

  5. Attainment of Stage 0 or 1 lower GI aGvHD, liver aGvHD, skin aGvHD, or upper GI aGvHD

    Measured: Days 7, 14, 28, 56, and 180

  6. Change or shift in overall Grade of aGvHD

    Measured: Day 0 - Days 7, 14, 28, 56, and 180.

  7. Overall survival

    Measured: Day 1 - Day 180

  8. Non-relapse mortality

    Measured: Day 1 - Day 180

  9. Duration of hospital stay

    Measured: Day 1 - Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2024
  2. Study start31 Aug 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06343792
Sponsor's protocol ID
RLS-0071-203
Acronym
AURORA
Status last verified
Nov 2025
First submitted
14 Mar 2024
Last updated
24 Nov 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Holzmuller V, Gawron J, Burk AC, Stell AV, Baur AS, Zahringer A, Fetsch V, Mader A, Hartmann A, Talvard-Balland N, Krishna N, Cunnion K, Thienel U, Martini P, Glenn L, Ferrara JL, Al Malki MM, Choe H, Perez-Simon JA, Schmitt-Graeff A, Buescher J, Kohler N, Mansoori Moghadam Z, Henneke P, Andrieux G, Boerries M, Zeiser R. Pegtarazimod limits acute graft-versus-host disease mortality and severity in mice and is tolerated in patients. J Clin Invest. 2026 Aug 4;136(19):e205864. doi: 10.1172/JCI205864. eCollection 2026 Oct 1.

    PubMed 42550614

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RLS-0071 in people with Steroid Refractory GVHD, run by ReAlta Life Sciences, Inc. at 11 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Spain, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Linda Dell, MBA (201-675-4044, ldell@realtals.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-related adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) (time frame: Day 1 to Day 180). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06343792, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.

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