Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT07155369
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-04
First Post:
2025-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
UCAR T-cell Therapy Targeting CD19/ BCMA in Patients With Relapse/ Refractory Autoimmune Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D012595', 'term': 'Scleroderma, Systemic'}], 'ancestors': [{'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'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'C024352', 'term': 'fludarabine'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-01', 'studyFirstSubmitDate': '2025-08-20', 'studyFirstSubmitQcDate': '2025-09-01', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the safety and tolerability of UCAR T-cell in participants with relapse/ refractory autoimmune diseases', 'timeFrame': '2 years', 'description': 'The incidence and severity of adverse events (AEs)'}, {'measure': 'To evaluate the clinical responses and duration of UCAR-T cells in participants with relapse/ refractory autoimmune diseases', 'timeFrame': '2 years', 'description': 'Proportion of participants achieving SRI-4 response, change in the Systemic Lupus Erythematosus Disease Activity Index(SLEDAI) from baseline'}], 'secondaryOutcomes': [{'measure': 'To characterize the cellular kinetics of UCAR T-cell in participants with relapse/ refractory autoimmune diseases', 'timeFrame': '2 years', 'description': 'AUC0-28d'}, {'measure': 'To characterize the cellular kinetics of UCAR T-cell in participants with relapse/ refractory autoimmune diseases', 'timeFrame': '2 years', 'description': 'Cmax'}, {'measure': 'To characterize the cellular kinetics of UCAR T-cell in participants with relapse/ refractory autoimmune diseases', 'timeFrame': '2 years', 'description': 'Tmax'}, {'measure': 'To characterize pharmacodynamics of of UCAR-T cells in participants.', 'timeFrame': '2 years', 'description': 'Changes in B-cell levels in the peripheral blood from baseline.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Lupus Erythematosus', 'Systemic Sclerosis']}, 'descriptionModule': {'briefSummary': 'This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in With Relapse/Refractory Autoimmune Diseases.', 'detailedDescription': 'This is an investigator-initiated trial to evaluate the safety and efficacy ofuniversal allogeneic anti-CD19/BCMA CAR T-cells in Patients With Relapse/Refractory Autoimmune Diseases.\n\nStudy intervention consists of a single infusion of universal allogeneic CART-cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years old (inclusive), regardless of gender.\n2. Positive expression of CD19 on peripheral blood B cells confirmed by flow cytometry.\n3. Adequate hepatic, renal and bone marrow function.\n4. Participants with relapsed or refractory autoimmune diseases, Including SLE or SSc.\n\nExclusion Criteria:\n\n1. Participants with a history of severe drug allergies or allergic constitutions.\n2. Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections.\n3. Participants with insufficient cardiac function.\n4. Participants with congenital immunoglobulin deficiencies.\n5. History of malignancy within five years.'}, 'identificationModule': {'nctId': 'NCT07155369', 'briefTitle': 'UCAR T-cell Therapy Targeting CD19/ BCMA in Patients With Relapse/ Refractory Autoimmune Diseases', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of Xuzhou Medical University'}, 'officialTitle': 'A Clinical Study Evaluating the Safety and Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases', 'orgStudyIdInfo': {'id': 'QH-XZ-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UCAR T-cell group', 'description': 'Participants will receive the following interventions and dose escalated per protocol:\n\nBiological: UCAR-T cells Drug: Cyclophosphamide Drug: Fludarabine', 'interventionNames': ['Biological: UCAR-T cells', 'Drug: Cyclophosphamide', 'Drug: Fludarabine']}], 'interventions': [{'name': 'UCAR-T cells', 'type': 'BIOLOGICAL', 'description': 'UCAR-T cells will be administered intravenously as per the schedule specified in the protocol.', 'armGroupLabels': ['UCAR T-cell group']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Cyclophosphamide will be administered intravenously.', 'armGroupLabels': ['UCAR T-cell group']}, {'name': 'Fludarabine', 'type': 'DRUG', 'description': 'Fludarabine will be administered intravenously.', 'armGroupLabels': ['UCAR T-cell group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Xuzhou', 'country': 'China', 'facility': 'The Affiliated Hospital of Xuzhou Medical University', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Hospital of Xuzhou Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Xiniao Biotech Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}