Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-01-19 @ 10:23 AM
Study NCT ID:
NCT04883918
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-20
First Post:
2021-05-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ASC930 in Patients With Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-18', 'studyFirstSubmitDate': '2021-05-07', 'studyFirstSubmitQcDate': '2021-05-07', 'lastUpdatePostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate (ORR) at Day 28', 'timeFrame': '28 days post-infusion'}, {'measure': 'Number of adverse events, and serious AEs', 'timeFrame': '30 days post-infusion'}], 'secondaryOutcomes': [{'measure': 'Duration of response (DOR) at DAY 180', 'timeFrame': '180 days post-infusion'}, {'measure': 'Overall survival (OS) rate at DAY 180', 'timeFrame': '180 days post-infusion'}, {'measure': 'Complete Response (CR) at Day 28 and Day 180', 'timeFrame': '28 and 180 days post-infusion'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute-graft-versus-host Disease']}, 'descriptionModule': {'briefSummary': 'Acute GVHD following allogeneic HCT is an immune-triggered process, leading to profound immune dysregulation and organ dysfunction. Despite pivotal advances, aGVHD is one of the leading causes of non-relapse mortality in patients undergoing HCT.\n\nPlacenta-derived DSCs, isolated from the fetal membrane of maternal origin, are a type of stromal cells with well-characterized immunosuppressive properties. The current study is designed to assess the safety and efficacy of 4 intravenous (IV) doses of ASC930 DSC cells in aGVHD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants ≥ 2 months of age\n* Diagnosis of aGVHD grade II-IV following allogeneic HSCT according to standard criteria (Harris, 2016).\n* Diagnosis of SR-aGVHD according to Mohty (2020)\n* Meet one of the following criteria:\n\n * Participants who are Ruxolitinib-refractory, according to Mohty (2020)\n * Participants who are not eligible for SOC therapy\n * Participants who agree to receive ASC930 as a second-line therapy\n* Karnofsky/Lansky Performance Status of at least 30 at the time of study entry\n* Minor participants must be capable of giving written assent as appropriate per the applicable age (per local regulatory requirements).\n\nExclusion Criteria:\n\n* Diagnosis of active Hepatic Sinusoidal Obstruction Syndrome (SOS)\n* Presence of an active uncontrolled infection\n* Active treatment for a hyprecoagulation disorder\n* Evidence of diffuse alveolar hemorrhage or other active pulmonary disease\n* Evidence of encephalopathy as defined by a change in mental status since the onset of aGVHD\n* Evidence of relapse of malignancy\n* Receival of agents other than steroids for primary treatment of aGVHD\n* Severe allergic history to cell-based products'}, 'identificationModule': {'nctId': 'NCT04883918', 'briefTitle': 'ASC930 in Patients With Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'ASC Therapeutics'}, 'officialTitle': 'Evaluation of Safety and Efficacy of ASC930 in Patients With Steroid-Refractory Acute Graft Versus Host Disease', 'orgStudyIdInfo': {'id': 'ASC-aGVHD-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASC930', 'description': 'Experimental Arm', 'interventionNames': ['Biological: ASC930']}], 'interventions': [{'name': 'ASC930', 'type': 'BIOLOGICAL', 'description': '4 intravenous doses of ASC930', 'armGroupLabels': ['ASC930']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Clinical Trial Manager, PhD', 'role': 'CONTACT', 'email': 'gil.gonen@asctherapeutics.com', 'phone': '(408) 495-3891'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ASC Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}