Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
Study NCT ID:
NCT06343792
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2024-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, PK, PD, Dosing, and Efficacy of RLS-0071for the Treatment of Hospitalized Patients With Steroid-Refractory Acute Graft-versus-Host Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722534', 'term': 'RLS-0071'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2024-03-14', 'studyFirstSubmitQcDate': '2024-03-26', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'Day 1 to Day 180'}, {'measure': 'Overall Response Rate (ORR) of RLS-0071', 'timeFrame': 'Day 1 to Day 28'}], 'secondaryOutcomes': [{'measure': 'Incidence of refractoriness (to RLS-0071 +/- ruxolitinib)', 'timeFrame': 'Days 7, 14, 28, 56, and 180'}, {'measure': 'Overall corticosteroid use', 'timeFrame': 'Days 7, 14, 28, 56, and 180'}, {'measure': 'Initiation of additional or alternative treatment(s) for aGvHD (including an increase in steroid dose to >2 mg/kg methylprednisolone equivalent)', 'timeFrame': 'Day 1 - Day 180'}, {'measure': 'Change or shift in Stage for lower GI aGvHD, liver aGvHD, skin aGvHD, or upper GI aGvHD from baseline based on MAGIC Criteria', 'timeFrame': 'Days 7, 14, 28, 56, and 180'}, {'measure': 'Attainment of Stage 0 or 1 lower GI aGvHD, liver aGvHD, skin aGvHD, or upper GI aGvHD', 'timeFrame': 'Days 7, 14, 28, 56, and 180'}, {'measure': 'Change or shift in overall Grade of aGvHD', 'timeFrame': 'Day 0 - Days 7, 14, 28, 56, and 180.'}, {'measure': 'Overall survival', 'timeFrame': 'Day 1 - Day 180'}, {'measure': 'Non-relapse mortality', 'timeFrame': 'Day 1 - Day 180'}, {'measure': 'Duration of hospital stay', 'timeFrame': 'Day 1 - Day 180'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Steroid Refractory GVHD']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female adults or adolescents (\\>12 years old).\n* Hospitalized with steroid-refractory aGvHD (grade II-IV) after allo-HSCT\n* Anticipated hospital length-of-stay of at least 1 week from the time of RLS-0071 initiation.\n* 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.\n* 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\n* Weight ≥40 kg and ≤ 140 kg at screening.\n\nExclusion Criteria:\n\n* Has received more than 1 allo-HSCT\n* Current, previous, or planned use of any systemic treatment in addition to or other than corticosteroids or ruxolitinib for aGvHD\n* Previous failure of ruxolitinib treatment\n* Uncontrolled GI infection\n* Endoscopic and biopsy testing (if performed) that definitively rules out lower GI aGvHD\n* Chronic GvHD\n* Participants with evidence of relapsed primary disease, or participants who have been treated for relapse after the allo-HSCT was performed.\n* Unresolved toxicity or complications (other than aGvHD) due to the allo-HSCT\n* Any corticosteroid therapy for indications other than aGvHD at doses of methylprednisolone or equivalent \\>1 mg/kg per day within 7 days of enrollment.\n* Severe organ dysfunction unrelated to underlying aGvHD\n* Known hypersensitivity, allergy, or anaphylactic reaction to polyethylene glycol (PEG)\n* Significant liver disease that is unrelated to GvHD\n* Severe kidney disease\n* Currently breast feeding.\n* Known pregnancy, a positive pregnancy test at screening, or lactation for WOCBP.\n* Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or human immunodeficiency virus (HIV)-1 or HIV-2.\n* Active sepsis'}, 'identificationModule': {'nctId': 'NCT06343792', 'acronym': 'AURORA', 'briefTitle': 'Safety, PK, PD, Dosing, and Efficacy of RLS-0071for the Treatment of Hospitalized Patients With Steroid-Refractory Acute Graft-versus-Host Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'ReAlta Life Sciences, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'RLS-0071-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RLS-0071Cohort 1', 'description': '10 mg/kg Q8H RLS-0071 for 7 days', 'interventionNames': ['Drug: RLS-0071']}, {'type': 'EXPERIMENTAL', 'label': 'RLS-0071 Cohort 2', 'description': '10 mg/kg Q8H RLS-0071 for 14 days with concurrent ruxolitinib', 'interventionNames': ['Drug: RLS-0071']}, {'type': 'EXPERIMENTAL', 'label': 'RLS-0071 Cohort 3', 'description': '20 mg/kg Q8H RLS-0071 for 14 days with concurrent ruxolitinib', 'interventionNames': ['Drug: RLS-0071']}, {'type': 'EXPERIMENTAL', 'label': 'RLS-0071 Cohort 4', 'description': '10 mg/kg Q8H RLS-0071 for 7 days and then 10 mg/kg QD RLS-0071 for 7 days with concurrent ruxolitinib', 'interventionNames': ['Drug: RLS-0071']}, {'type': 'EXPERIMENTAL', 'label': 'RLS-0071 Cohort 5', 'description': '20 mg/kg Q8H RLS-0071 for 7 days and then 20 mg/kg QD RLS-0071 for 7 days with concurrent ruxolitinib', 'interventionNames': ['Drug: RLS-0071']}, {'type': 'EXPERIMENTAL', 'label': 'RLS-0071 Expansion Cohort 1', 'description': '12 participants will receive 10 mg/kg Q8H RLS-0071 for 14 days', 'interventionNames': ['Drug: RLS-0071']}, {'type': 'EXPERIMENTAL', 'label': 'RLS-0071 Expansion Cohort 2', 'description': '12 participants will receive 20 mg/kg Q8H RLS-0071 for 14 days', 'interventionNames': ['Drug: RLS-0071']}], 'interventions': [{'name': 'RLS-0071', 'type': 'DRUG', 'description': 'RLS-0071 will be administered for 7 or 14 days according to the assigned dose group.', 'armGroupLabels': ['RLS-0071 Cohort 2', 'RLS-0071 Cohort 3', 'RLS-0071 Cohort 4', 'RLS-0071 Cohort 5', 'RLS-0071 Expansion Cohort 1', 'RLS-0071 Expansion Cohort 2', 'RLS-0071Cohort 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Site 1091', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Site 1343', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '30041', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Site 1318', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Site 1068', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Site 1100', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Site 1382', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Site 3242', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '41013', 'city': 'Seville', 'state': 'SE', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Site 3101', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Site 3360', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Salamanca', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Site 3227', 'geoPoint': {'lat': 40.42972, 'lon': -3.67975}}, {'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Site 3101', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'centralContacts': [{'name': 'Linda Dell, MBA', 'role': 'CONTACT', 'email': 'ldell@realtals.com', 'phone': '201-675-4044'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ReAlta Life Sciences, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'CTI Clinical Trial and Consulting Services', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}