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

Steroid Refractory GVHD Clinical Trial

— AURORA  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06343792
• Other study ID #: RLS-0071-203
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 2024
• Est. completion date: September 2025

Study information

• Verified date: March 2024
• Source: ReAlta Life Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: September 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

• Moderate to 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

Related Conditions & MeSH terms

• Graft vs Host Disease
• Steroid Refractory GVHD

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ReAlta Life Sciences, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)		Day 1 to Day 180
Primary	Overall Response Rate (ORR) of RLS-0071		Day 1 to Day 28
Secondary	Incidence of refractoriness (to RLS-0071 +/- ruxolitinib)		Days 7, 14, 28, 56, and 180
Secondary	Overall corticosteroid use		Days 7, 14, 28, 56, and 180
Secondary	Initiation of additional or alternative treatment(s) for aGvHD (including an increase in steroid dose to >2 mg/kg methylprednisolone equivalent)		Day 1 - Day 180
Secondary	Change or shift in Stage for lower GI aGvHD, liver aGvHD, skin aGvHD, or upper GI aGvHD from baseline based on MAGIC Criteria		Days 7, 14, 28, 56, and 180
Secondary	Attainment of Stage 0 or 1 lower GI aGvHD, liver aGvHD, skin aGvHD, or upper GI aGvHD		Days 7, 14, 28, 56, and 180
Secondary	Change or shift in overall Grade of aGvHD		Day 0 - Days 7, 14, 28, 56, and 180.
Secondary	Overall survival		Day 1 - Day 180
Secondary	Non-relapse mortality		Day 1 - Day 180
Secondary	Duration of hospital stay		Day 1 - Day 180