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

Phase 2 Recruiting 66 enrolled ReAlta Life Sciences, Inc. CTI Clinical Trial and Consulting Services · collab

Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start: 2024-08-31
Primary completion: 2026-12
Completion: 2026-12

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RLS-0071	Peptide	10 mg/kg	—
Subject	RLS-0071	Peptide	20 mg/kg	—

Indications

No indication recorded.