Safety, PK, PD, Dosing, and Efficacy of RLS-0071for the Treatment of Hospitalized Patients With Steroid-Refractory Acute Graft-versus-Host Disease
NCT ID: NCT06343792
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
66 participants
INTERVENTIONAL
2024-08-31
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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RLS-0071Cohort 1
10 mg/kg Q8H RLS-0071 for 7 days
RLS-0071
RLS-0071 will be administered for 7 or 14 days according to the assigned dose group.
RLS-0071 Cohort 2
10 mg/kg Q8H RLS-0071 for 14 days with concurrent ruxolitinib
RLS-0071
RLS-0071 will be administered for 7 or 14 days according to the assigned dose group.
RLS-0071 Cohort 3
20 mg/kg Q8H RLS-0071 for 14 days with concurrent ruxolitinib
RLS-0071
RLS-0071 will be administered for 7 or 14 days according to the assigned dose group.
RLS-0071 Cohort 4
10 mg/kg Q8H RLS-0071 for 7 days and then 10 mg/kg QD RLS-0071 for 7 days with concurrent ruxolitinib
RLS-0071
RLS-0071 will be administered for 7 or 14 days according to the assigned dose group.
RLS-0071 Cohort 5
20 mg/kg Q8H RLS-0071 for 7 days and then 20 mg/kg QD RLS-0071 for 7 days with concurrent ruxolitinib
RLS-0071
RLS-0071 will be administered for 7 or 14 days according to the assigned dose group.
RLS-0071 Expansion Cohort 1
12 participants will receive 10 mg/kg Q8H RLS-0071 for 14 days
RLS-0071
RLS-0071 will be administered for 7 or 14 days according to the assigned dose group.
RLS-0071 Expansion Cohort 2
12 participants will receive 20 mg/kg Q8H RLS-0071 for 14 days
RLS-0071
RLS-0071 will be administered for 7 or 14 days according to the assigned dose group.
Interventions
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RLS-0071
RLS-0071 will be administered for 7 or 14 days according to the assigned dose group.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* 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
12 Years
ALL
No
Sponsors
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CTI Clinical Trial and Consulting Services
OTHER
ReAlta Life Sciences, Inc.
INDUSTRY
Responsible Party
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Locations
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Site 1091
Duarte, California, United States
Site 1343
Los Angeles, California, United States
Site 1318
Atlanta, Georgia, United States
Site 1068
St Louis, Missouri, United States
Site 1100
Cincinnati, Ohio, United States
Site 1382
Columbus, Ohio, United States
Site 3242
Freiburg im Breisgau, , Germany
Site 3101
Seville, SE, Spain
Site 3360
Madrid, , Spain
Site 3227
Salamanca, , Spain
Site 3101
Seville, , Spain
Countries
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Central Contacts
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Other Identifiers
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RLS-0071-203
Identifier Type: -
Identifier Source: org_study_id
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