RLS-0071 for Graft-versus-Host Disease

(AURORA Trial)

Recruiting at 11 trial locations

Overseen By Linda Dell, MBA

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: ReAlta Life Sciences, Inc.

Must be taking: Corticosteroids, Ruxolitinib

Must not be taking: Systemic treatments

Disqualifiers: Chronic GvHD, Severe organ dysfunction, Active sepsis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1-2 weeks

66 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop your current medications, but it does require that you do not add, adjust, or stop any GvHD prophylactic medications during the 7-day treatment with RLS-0071.

What is the purpose of this trial?

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 Criteria

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.

Inclusion Criteria

I am older than 12 years.

I am in the hospital for aGvHD that didn't respond to steroids after a stem cell transplant.

I won't change my GvHD treatment plan for 7 days during RLS-0071 treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive RLS-0071 in various dosing regimens for 7 to 14 days, with some cohorts receiving concurrent ruxolitinib

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• RLS-0071

Trial Overview 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.

Participant Groups

Group I: RLS-0071Cohort 1 Experimental Treatment 1 Intervention

10 mg/kg Q8H RLS-0071 for 7 days

Group II: RLS-0071 Expansion Cohort 2 Experimental Treatment 1 Intervention

12 participants will receive 10 or 40 mg/kg Q8H RLS-0071 for 7 or 14 days

Group III: RLS-0071 Expansion Cohort 1 Experimental Treatment 1 Intervention

12 participants will receive 10 or 40 mg/kg Q8H RLS-0071 for 7 or 14 days

Group IV: RLS-0071 Cohort 6 Experimental Treatment 1 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 5 Experimental Treatment 1 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 4 Experimental Treatment 1 Intervention

40 mg/kg Q8H RLS-0071 for 14 days with concurrent ruxolitinib

Group VII: RLS-0071 Cohort 3 Experimental Treatment 1 Intervention

10 mg/kg Q8H RLS-0071 for 14 days with concurrent ruxolitinib

Group VIII: RLS-0071 Cohort 2 Experimental Treatment 1 Intervention

40 mg/kg Q8H RLS-0071 for 7 days

Who Is Running the Clinical Trial?

ReAlta Life Sciences, Inc.

Lead Sponsor

Trials

6

Recruited

220+

CTI Clinical Trial and Consulting Services

Collaborator

Trials

36

Recruited

3,700+