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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Steroid Refractory GVHD
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope National Medical Center, Duarte, California, United States, 91010

Los Angeles

UCLA, Los Angeles, California, United States, 90095

Saint Louis

Washington University, Saint Louis, Missouri, United States, 63110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

12 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

ReAlta Life Sciences, Inc.,

Study Record Dates

2025-09