Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-10 @ 10:39 AM
Study NCT ID:
NCT07001956
Status:
RECRUITING
Last Update Posted:
2025-07-18
First Post:
2025-05-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Clinical Study on the Treatment of Refractory RA With UTAA91 Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'UTAA91 injection'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2040-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2025-05-25', 'studyFirstSubmitQcDate': '2025-05-25', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'About 1 year', 'description': 'The types, frequency, and severity of adverse events (AEs) and laboratory abnormalities (according to the Common Terminology Criteria for Adverse Events, NCI CTCAE 5.0).'}], 'secondaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'About 1 year', 'description': 'Maximum concentration of UTAA91 injection amplified in peripheral blood after administration of the drug'}, {'measure': 'Tmax', 'timeFrame': 'About 1 year', 'description': 'Time to reach maximum concentration in peripheral blood after administration of UTAA91 injection'}, {'measure': 'Disease remission rate', 'timeFrame': 'About 3 months', 'description': 'The disease remission/response/improvement rates at 28 days, 2 months, and 3 months after treatment with UTAA91 injection.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis (RA)']}, 'descriptionModule': {'briefSummary': 'This clinical trial is designed as a single - arm, open - label, single - center, investigator - initiated early - phase clinical study. The primary objective is to evaluate the safety of UTAA91 injection in treating subjects with refractory moderate - to - severe active rheumatoid arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥18 years (inclusive of the boundary value), with no restriction on gender.\n* Expected survival time of at least 3 months.\n* Subjects with refractory moderate - to - severe active rheumatoid arthritis who have failed standard treatment or lack effective therapeutic options.\n* Meet the requirements for liver and kidney function, as well as cardiopulmonary function.\n* Free from severe psychiatric disorders.\n* Able to understand the trial and have signed the informed consent form.\n\nExclusion Criteria:\n\n* A history of malignant tumors other than relapsed/refractory autoimmune diseases (R/R AID) within 5 years prior to screening.\n* Subjects with positive results in virus/syphilis tests.\n* Severe cardiac diseases or unstable systemic diseases.\n* Active or uncontrollable infections requiring systemic treatment within 7 days before administration; evidence of central nervous system invasion at screening.\n* Pregnant or breastfeeding women, female subjects planning to become pregnant within 2 years after cell infusion, or male subjects whose partners plan to become pregnant within 2 years after their cell infusion.\n* Subjects who have received CAR - T therapy or other gene - modified cell therapies before screening.\n* Subjects who participated in other clinical studies within 1 month before screening.\n* Other conditions deemed unsuitable for enrollment by the investigator.'}, 'identificationModule': {'nctId': 'NCT07001956', 'briefTitle': 'The Clinical Study on the Treatment of Refractory RA With UTAA91 Injection', 'organization': {'class': 'OTHER', 'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, 'officialTitle': 'Clinical Study on the Treatment of Refractory Moderate - to - Severe Active Rheumatoid Arthritis With UTAA91 Injection', 'orgStudyIdInfo': {'id': 'PG-011-9 (1)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UTAA91 injection', 'interventionNames': ['Biological: UTAA91 injection']}], 'interventions': [{'name': 'UTAA91 injection', 'type': 'BIOLOGICAL', 'description': 'After signing the informed consent form, eligible subjects will receive an infusion of UTAA91 injection. Blood samples will be collected from the subjects before and after the infusion for the evaluation of pharmacokinetics, pharmacodynamics, immunogenicity, and safety.', 'armGroupLabels': ['UTAA91 injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430000', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiubai Li, MD', 'role': 'CONTACT', 'email': 'qiubaili@hust.edu.cn', 'phone': '+8613995671635'}], 'facility': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Qiubai Li, MD', 'role': 'CONTACT', 'email': 'qiubaili@hust.edu.cn', 'phone': '+8613995671635'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Head of Department of Rheumatology and Immunology，Principal Investigator', 'investigatorFullName': 'Qiubai Li', 'investigatorAffiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}}}}