Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2026-04-14 @ 1:58 AM
Study NCT ID:
NCT06566261
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-03
First Post:
2024-08-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ABA-101 in Participants With Progressive Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020528', 'term': 'Multiple Sclerosis, Chronic Progressive'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Sequential Escalating Dose Cohorts'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2024-08-20', 'studyFirstSubmitQcDate': '2024-08-20', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events (safety and tolerability)', 'timeFrame': 'Day of Treatment to End of DLT Evaluation Period (28 Days)', 'description': 'Incidence of AEs through Day 29'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Progressive Multiple Sclerosis', 'Cell Therapy', 'Multiple Sclerosis', 'Treg', 'Regulatory T Cell'], 'conditions': ['Progressive Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'This study will test the safety and effects of ABA-101 when given as a single dose to participants with progressive multiple sclerosis.\n\nIt is the first study of this treatment in humans. After safety is demonstrated with a low dose of ABA-101, a higher dose will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is ≥18 years old at signing of consent.\n* Has a diagnosis of MS per the 2017 revised McDonald criteria.\n* Has documented evidence of progression of disability independent of MS relapse activity (clinical or radiographic).\n* Expresses the HLA that matches the TCR restriction.\n* Presence of a radiographic biomarker of CNS inflammation as identified by MRI.\n* Meets Expanded Disability Status Scale (EDSS) criteria.\n* Meets the nine-hole peg test (9HPT) criteria.\n\nExclusion Criteria:\n\n* Presents with clinical or radiographic evidence of relapse within 24 months prior to or at Screening.\n* Is considered by the Investigator to be immunocompromised.\n* Current treatment with disease-modifying therapies (DMTs).'}, 'identificationModule': {'nctId': 'NCT06566261', 'briefTitle': 'ABA-101 in Participants With Progressive Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abata Therapeutics'}, 'officialTitle': 'A Phase 1 Open-label, Single Ascending Dose Study of ABA-101 in Participants With Progressive Multiple Sclerosis', 'orgStudyIdInfo': {'id': '101-PMS-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABA-101 Dose 1', 'description': 'Low Dose ABA-101', 'interventionNames': ['Biological: ABA-101']}, {'type': 'EXPERIMENTAL', 'label': 'ABA-101 Dose 2', 'description': 'High Dose ABA-101', 'interventionNames': ['Biological: ABA-101']}], 'interventions': [{'name': 'ABA-101', 'type': 'BIOLOGICAL', 'description': 'ABA-101 is a TCR engineered, autologous regulatory T cell (Treg) therapy', 'armGroupLabels': ['ABA-101 Dose 1', 'ABA-101 Dose 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers, Robert Wood Johnson Medical School', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Mellen Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Samantha Singer, President and CEO, Abata Therapeutics, MS MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abata Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abata Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}