Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:17 PM
Study NCT ID:
NCT06653556
Status:
RECRUITING
Last Update Posted:
2025-01-10
First Post:
2024-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of LCAR-AIO in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D000744', 'term': 'Anemia, Hemolytic, Autoimmune'}, {'id': 'D008181', 'term': 'Lupus Nephritis'}], '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': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2029-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-08', 'studyFirstSubmitDate': '2024-10-11', 'studyFirstSubmitQcDate': '2024-10-20', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence, severity, and type of treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Minimum 104 Weeks after LCAR-AIO infusion (Day 1)', 'description': 'An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment.'}, {'measure': 'Incidence of dose-limiting toxicity (DLT)', 'timeFrame': '30 days after LCAR-AIO infusion (Day 1)', 'description': 'DLTs are severe adverse events refers to any untoward medical occurred in a subject participated in a clinical investigation, which have a causal relationship with the treatment and will limit the dose escalation.'}, {'measure': 'Pharmacokinetics in peripheral blood', 'timeFrame': 'Minimum 104 Weeks after LCAR-AIO infusion (Day 1)', 'description': 'CAR positive T cells levels in peripheral blood after LCAR-AIO infusion.'}, {'measure': 'Recommended Phase 2 Dose (RP2D) regimen finding', 'timeFrame': 'Minimum 104 Weeks after LCAR-AIO infusion (Day 1)', 'description': 'RP2D established through dose exploratory.'}], 'secondaryOutcomes': [{'measure': 'Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline up to 104 weeks', 'timeFrame': 'Minimum 104 Weeks after LCAR-AIO infusion (Day 1)', 'description': "The SELENA-2K scale is a cumulative and weighted index used to assess disease activity across 24 different disease descriptors in patients with lupus. A patient's SELENA-2K total score is the sum of all marked lupus related descriptors (seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, cerebrovascular accident, vasculitis, arthritis, myositis, urinary casts, hematuria, proteinuria, pyuria, new rash, alopecia, mucosal ulcers, pleurisy, pericarditis, low complement, increased DNA binding, fever, thrombocytopenia, leukopenia). A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity."}, {'measure': 'Change in Physician global assessment (PGA) scores from baseline up to 104 weeks', 'timeFrame': 'Minimum 104 Weeks after LCAR-AIO infusion (Day 1)', 'description': 'The physician will place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (Score 0) represents "no activity", and the right-hand boundary (score 3) represents "the most severe activity".'}, {'measure': 'Lupus Low Disease Activity State (LLDAS) response rates at multiple visits post-infusion', 'timeFrame': 'Minimum 104 Weeks after LCAR-AIO infusion (Day 1)', 'description': 'Percentage of participants achieving the LLDAS. The LLDAS is a composite measure designed to identify patients achieving a state of low disease activity. The LLDAS response criteria were: (1) SLEDAI-2K \\<=4, with no activity in major organ systems (Central nervous system, vascular, renal, cardiorespiratory and constitutional); where "no activity" is defined as all items of SLEDAI-2K within these major organ systems equal to 0. (2) no new features of lupus disease activity compared to previous occurred visit, where the "new feature" is defined as any of the SLEDAI-2K 24 items changed from 0 to greater than 0; (3) Physician global assessment (PGA) (score 0-3), \\<=1; (4) current prednisolone (or equivalent) dose \\<=7.5 mg dailyultiple visits.'}, {'measure': '24h urinary protein/urine protein-to-creatinine ratio (UPCR) changes from baseline up to 104 weeks', 'timeFrame': 'Minimum 104 Weeks after LCAR-AIO infusion (Day 1)', 'description': 'Proteinuria will be assessed in lupus nephritis patients basing on 24h urinary protein/UPCR at multiple visits.'}, {'measure': 'Changes from baseline in immunological markers and Immunogenicity (anti-drug antibody)', 'timeFrame': 'Time Frame: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)', 'description': 'Detection of Immunoglobulins, anti-drug antibodies (anti-dsDNA antibody, anti-Sm antibody, etc.) and anti-drug antibody.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Refractory pulmonary Hypertension (PAH)', 'Recurrent/refractory autoimmune hemolytic anemia (r/r AIHA)', 'Recurrent/refractory lupus nephritis (r/r LN)'], 'conditions': ['Systemic Lupus Erythematosus (SLE)']}, 'descriptionModule': {'briefSummary': 'This is a prospective, single-arm, open-label, dose-exploration and expansion clinical study of LCAR-AIO in adult subjects with relapsed/refractory systemic lupus erythematosus.', 'detailedDescription': 'This is a prospective, single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy profiles of LCAR-AIO, a chimeric antigen receptor (CAR) -T cell therapy in subjects with relapsed/refractory systemic lupus erythematosus. Patients who meet the eligibility criteria will receive LCAR-AIO infusion. The study will include the following sequential stages: screening, apheresis, pre-treatment (cell product preparation: lymphodepleting chemotherapy), treatment (LCAR AIO infusion) and follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '1. Subjects voluntarily participate in clinical research.\n2. Age 18-65 years.\n3. Have been diagnosed of SLE at least 6 months before screening.\n4. At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Sm antibody should be positive.\n5. Fulfill relapsed/refractory SLE conditions.\n6. Adequate organ function at screening.\n7. Clinical laboratory values meet criteria at screening.\n\nExclusion Criteria:\n\n1. Active infections such as hepatitis and tuberculosis.\n2. Other autoimmune diseases.\n3. Serious underlying diseases such as tumor, uncontrolled diabetes.\n4. Female subjects who were pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving LCAR-AIO treatment.\n5. Participated in other clinical trials within'}, 'identificationModule': {'nctId': 'NCT06653556', 'briefTitle': 'A Study of LCAR-AIO in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus', 'organization': {'class': 'OTHER', 'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, 'officialTitle': 'An Open-label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LCAR-AIO for the Treatment of Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE)', 'orgStudyIdInfo': {'id': 'LB2305-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LCAR-AIO T Cells', 'description': 'Experimental: Chimeric antigen receptor T cells (LCAR-AIO)\n\nEach subject will be given a single-dose LCAR-AIO cells infusion at each dose level', 'interventionNames': ['Biological: LCAR-AIO T cells']}], 'interventions': [{'name': 'LCAR-AIO T cells', 'type': 'BIOLOGICAL', 'description': 'Before treatment with LCAR-AIO T cells, subjects will receive a conditioning regimen.', 'armGroupLabels': ['LCAR-AIO T Cells']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Wuhan Union Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Qiubai Li, Professor', 'role': 'CONTACT', 'email': 'qiubaili@hust.edu.cn', 'phone': '85726808', 'phoneExt': '027'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nanjing Legend Biotech Co.', 'class': 'INDUSTRY'}, {'name': 'Beijing GoBroad Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Qiubai Li', 'investigatorAffiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}}}}