Actively Recruiting
Safety, PK, PD, Dosing, and Efficacy of RLS-0071for the Treatment of Hospitalized Patients With Steroid-Refractory Acute Graft-versus-Host Disease
Led by ReAlta Life Sciences, Inc. · Updated on 2025-11-24
66
Participants Needed
11
Research Sites
117 weeks
Total Duration
On this page
Sponsors
R
ReAlta Life Sciences, Inc.
Lead Sponsor
C
CTI Clinical Trial and Consulting Services
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Safety, PK, PD, Dosing, and Efficacy of RLS-0071for the Treatment of Hospitalized Patients With Steroid-Refractory Acute Graft-versus-Host Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female adults or adolescents (>12 years old)
- Hospitalized with steroid-refractory acute Graft-versus-Host Disease (grade II-IV) after allogeneic hematopoietic stem cell transplantation
- Expected hospital stay of at least 1 week from start of RLS-0071 treatment
- No plans to add or change GvHD treatment or prophylactic medications during 7 days of RLS-0071 treatment
- Neutrophil recovery with blood neutrophil count >500/mL for at least 3 consecutive tests without growth factor support
- Weight between 40 kg and 140 kg at screening
You will not qualify if you...
- More than one allogeneic hematopoietic stem cell transplant received
- Use of systemic treatments for aGvHD other than corticosteroids or ruxolitinib
- Previous failure of ruxolitinib treatment
- Uncontrolled gastrointestinal infection
- Endoscopic and biopsy results ruling out lower gastrointestinal aGvHD
- Chronic GvHD
- Evidence or treatment of relapsed primary disease after transplantation
- Unresolved toxicity or complications from transplantation other than aGvHD
- Corticosteroid therapy >1 mg/kg per day for non-aGvHD indications within 7 days before enrollment
- Severe organ dysfunction unrelated to aGvHD
- Allergy or anaphylaxis to polyethylene glycol (PEG)
- Significant liver disease unrelated to GvHD
- Severe kidney disease
- Currently breastfeeding
- Known pregnancy, positive pregnancy test at screening, or lactation for women of childbearing potential
- Active hepatitis B or C infection needing treatment, or HIV-1 or HIV-2 infection
- Active sepsis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Site 1091
Duarte, California, United States, 91010
Active, Not Recruiting
2
Site 1343
Los Angeles, California, United States, 90095
Active, Not Recruiting
3
Site 1318
Atlanta, Georgia, United States, 30041
Active, Not Recruiting
4
Site 1068
St Louis, Missouri, United States, 63110
Active, Not Recruiting
5
Site 1100
Cincinnati, Ohio, United States, 45229
Active, Not Recruiting
6
Site 1382
Columbus, Ohio, United States, 43210
Active, Not Recruiting
7
Site 3242
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
8
Site 3101
Seville, SE, Spain, 41013
Actively Recruiting
9
Site 3360
Madrid, Spain
Actively Recruiting
10
Site 3227
Salamanca, Spain
Actively Recruiting
11
Site 3101
Seville, Spain
Actively Recruiting
Research Team
L
Linda Dell, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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