NCT06343792

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: ReAlta Life Sciences, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Steroid Refractory GVHD

Interventions

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

Timeline

• Start date: 2024-08-31
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-04-03
• Last updated: 2025-11-24

Locations

11 sites across 3 countries: United States, Germany, Spain

Regulatory

• FDA-regulated drug study