Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

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.

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

Keywords

Steroid Refractory GVHD, Graft vs Host Disease, RLS-0071, RLS-0071Cohort 1

Eligibility

You can join if…

Open to people ages 12 years and up

  • 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.

You CAN'T join if...

  • 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

Locations

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

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
ReAlta Life Sciences, Inc.
ID
NCT06343792
Phase
Phase 2 Graft Versus Host Disease Research Study
Study Type
Interventional
Participants
Expecting 66 study participants
Last Updated