RECRUITING

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

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Conditions

Steroid Refractory GVHD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2024-08-31
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06343792

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.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female adults or adolescents (\>12 years old).
  2. * Hospitalized with steroid-refractory aGvHD (grade II-IV) after allo-HSCT
  3. * Anticipated hospital length-of-stay of at least 1 week from the time of RLS-0071 initiation.
  4. * 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.
  5. * 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
  6. * Weight \>40 kg and ≤ 140 kg at screening.
  1. * Has received more than 1 allo-HSCT
  2. * Current, previous, or planned use of any systemic treatment in addition to or other than corticosteroids or ruxolitinib for aGvHD
  3. * Previous failure of ruxolitinib treatment
  4. * Uncontrolled GI infection
  5. * Endoscopic and biopsy testing (if performed) that definitively rules out lower GI aGvHD
  6. * Chronic GvHD
  7. * Participants with evidence of relapsed primary disease, or participants who have been treated for relapse after the allo-HSCT was performed.
  8. * Unresolved toxicity or complications (other than aGvHD) due to the allo-HSCT
  9. * Any corticosteroid therapy for indications other than aGvHD at doses of methylprednisolone or equivalent \>1 mg/kg per day within 7 days of enrollment.
  10. * Severe organ dysfunction unrelated to underlying aGvHD
  11. * Known hypersensitivity, allergy, or anaphylactic reaction to polyethylene glycol (PEG)
  12. * Significant liver disease that is unrelated to GvHD
  13. * Moderate to severe kidney disease
  14. * Currently breast feeding.
  15. * Known pregnancy, a positive pregnancy test at screening, or lactation for WOCBP.
  16. * Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or human immunodeficiency virus (HIV)-1 or HIV-2.
  17. * Active sepsis

Contacts and Locations

Study Contact

Linda Dell, MBA
CONTACT
201-675-4044
ldell@realtals.com

Study Locations (Sites)

City of Hope National Medical Center
Duarte, California, 91010
United States
UCLA
Los Angeles, California, 90095
United States
Washington University
Saint Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: ReAlta Life Sciences, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-31
Study Completion Date2025-09

Study Record Updates

Study Start Date2024-08-31
Study Completion Date2025-09

Terms related to this study

Additional Relevant MeSH Terms

  • Steroid Refractory GVHD