Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-06 @ 9:22 AM
Study NCT ID:
NCT07432334
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CD19 CAR T-Cell Therapy for Refractory Systemic Lupus Erythematosus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-02-24', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of Frequency and Severity of Adverse Events and Serious Adverse Events', 'timeFrame': 'From CAR-T cell infusion through Day 360', 'description': 'Incidence, type, and severity of adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded according to ASTCT criteria.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants Achieving Remission According to DORIS Criteria', 'timeFrame': 'Day 90 and Day 360', 'description': 'Proportion of participants achieving complete or partial remission according to the Definitions of Remission in SLE (DORIS) criteria.'}, {'measure': 'Proportion of Participants Achieving Lupus Low Disease Activity State (LLDAS)', 'timeFrame': 'Day 90 and Day 360', 'description': 'Proportion of participants meeting Lupus Low Disease Activity State (LLDAS) criteria.'}, {'measure': 'Proportion of Participants Experiencing Disease Relapse', 'timeFrame': 'From Day 90 through Day 360', 'description': 'Proportion of participants with disease relapse after achieving clinical response.'}, {'measure': 'Manufacturing Success Rate of Autologous CD19 CAR-T Cells', 'timeFrame': 'From leukapheresis through product release, up to 12 days', 'description': 'Proportion of enrolled participants for whom autologous CD19 CAR-T cells are successfully manufactured and released for administration'}, {'measure': 'Peripheral CD19+ B-Cell Depletion and Reconstitution', 'timeFrame': 'Baseline, Day 7, Day 14, Day 28, Day 90, Day 180, and Day 360', 'description': 'Quantitative assessment of peripheral blood CD19+ B-cell counts at specified time points following CAR-T cell infusion.'}, {'measure': 'CAR-T Cell Expansion and Persistence', 'timeFrame': 'Baseline, Day 7, Day 14, Day 28, Day 90, Day 180, and Day 360', 'description': 'Quantitative assessment of circulating CAR-T cell levels in peripheral blood at specified time points following infusion.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CD19 CAR-T', 'Autoimmune Disease'], 'conditions': ['Refractory Systemic Lupus Erythematosus']}, 'descriptionModule': {'briefSummary': 'The goal of this Phase I clinical trial is to evaluate the safety and tolerability of autologous CD19-targeted chimeric antigen receptor T-cell (CAR-T) therapy in adults with refractory systemic lupus erythematosus who have demonstrated inadequate response to standard-of-care immunosuppressive treatments.\n\nThe primary questions this study aims to address are:\n\nWhat is the incidence, nature, and severity of treatment-emergent adverse events following CD19 CAR-T cell infusion? Is administration of CD19 CAR-T cell therapy feasible and tolerable in patients with refractory systemic lupus erythematosus? This study is conducted as a single-arm trial without a comparison group.\n\nParticipants will:\n\nUndergo leukapheresis for collection of autologous peripheral blood mononuclear cells Receive a protocol-defined lymphodepleting chemotherapy regimen prior to CAR-T cell infusion Receive a single intravenous infusion of approximately 1.0 × 10⁶ CD19 CAR-T cells per kilogram of body weight Undergo scheduled clinical evaluations, laboratory testing, and longitudinal follow-up to assess safety, tolerability, and clinical parameters', 'detailedDescription': 'This is a Phase I, single-center, open-label clinical trial evaluating the safety of autologous CD19-targeted chimeric antigen receptor T-cell (CAR-T) therapy in patients with refractory systemic lupus erythematosus (SLE).\n\nSystemic lupus erythematosus is a chronic autoimmune disease characterized by immune dysregulation and pathogenic autoantibody production, with B lymphocytes playing a central role in disease pathophysiology. Targeting CD19-expressing B cells represents a potential therapeutic strategy for patients with disease refractory to standard immunosuppressive therapies.\n\nAutologous CD19 CAR-T cells will be generated from peripheral blood T cells collected by leukapheresis. Cells will be genetically modified ex vivo to express a CD19-specific chimeric antigen receptor, expanded, and released for clinical administration following protocol-defined quality control testing and regulatory requirements.\n\nParticipants will receive a lymphodepleting chemotherapy regimen prior to a single intravenous infusion of CD19 CAR-T cells. Treatment administration and post-infusion monitoring will be conducted according to the protocol-specified safety and observation plan.\n\nFollowing infusion, participants will be monitored for treatment-emergent adverse events, including CAR-T-associated toxicities such as cytokine release syndrome, immune effector cell-associated neurotoxicity, cytopenias, and infections. Safety evaluations will include serial clinical assessments and laboratory monitoring.\n\nExploratory assessments will evaluate immunological parameters, including B-cell depletion and reconstitution, autoantibody profiles, and selected biomarkers of disease activity. Participants will undergo longitudinal follow-up to assess early and delayed adverse events and the persistence of immunological effects, in accordance with regulatory guidance for gene-modified cell therapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 16 to 55 years, male or female\n* Diagnosis of systemic lupus erythematosus (SLE) according to the 2019 EULAR/ACR classification criteria with a total score ≥ 10\n* SLEDAI-2K score ≥ 8 at screening (with at least 4 points derived from laboratory parameters; excluding points attributable to central nervous system involvement)\n* Positive antinuclear antibody (ANA ≥ 1:80) OR positive anti-dsDNA OR positive anti-Sm antibody at screening or documented in medical history\n\nRefractory systemic lupus erythematosus or refractory lupus nephritis defined as one of the following:\n\nRefractory SLE:\n\n\\- Failure to achieve adequate response, partial response, or stable disease control after ≥ 6 months of standard-of-care therapy (documented compliance). Standard therapy includes corticosteroids plus hydroxychloroquine and at least two of the following: calcineurin inhibitors, cyclophosphamide, mycophenolate mofetil, azathioprine, or B-cell-targeted therapy (e.g., rituximab, belimumab).\n\nRefractory Lupus Nephritis:\n\n* Persistent active lupus nephritis after two induction regimens, including intravenous cyclophosphamide and mycophenolate mofetil administered for ≥ 6 months (with or without calcineurin inhibitors, rituximab, or belimumab), AND:\n* Histopathologic confirmation of Class III or Class IV lupus nephritis, with or without Class V (ISN/RPS 2003 classification); isolated Class V is excluded\n* Proteinuria \\> 1 g/24 hours OR urine protein-to-creatinine ratio \\> 1 mg/mg\n* Adequate organ function:\n\n * ALT ≤ 5 × upper limit of normal; total bilirubin ≤ 34 μmol/L (≤ 2.0 mg/dL)\n * Pulmonary function: FVC ≥ 60% predicted OR FEV1 ≥ 60% predicted\n * Cardiac function: LVEF ≥ 50%, no uncontrolled arrhythmia, no intracardiac thrombus, no heart failure\n* Adequate hematologic parameters:\n\n * Absolute neutrophil count ≥ 0.8 × 10⁹/L (without growth factor support)\n * Absolute lymphocyte count ≥ 0.3 × 10⁹/L\n * Platelet count ≥ 50 × 10⁹/L\n * Hemoglobin ≥ 80 g/L (≥ 8.0 g/dL)\n* Ability to provide written informed consent\n* Agreement to use effective contraception during the study period (for participants of reproductive potential)\n\nExclusion Criteria:\n\n* History of significant neurologic disorders (e.g., traumatic brain injury, seizure disorder, hemorrhagic conditions, impaired consciousness)\n* Significant cardiovascular disease within 3 months prior to screening (e.g., uncontrolled hypertension, NYHA Class III-IV heart failure, severe arrhythmia, unstable angina, myocardial infarction)\n* Prior kidney transplantation\n* Severe asthma requiring long-term treatment or respiratory failure\n* Severe hemolytic anemia requiring transfusion at intervals ≤ 7 days\n* Active viral infections (e.g., hepatitis B or C, HIV, tuberculosis, malaria, syphilis, CMV, EBV) or other life-threatening infectious diseases\n* Active bacterial infection confirmed by clinical evaluation, imaging, or laboratory testing\n* Use of the following prior to leukapheresis:\n\n * Anti-CD20 therapy, cyclophosphamide, live or attenuated vaccines within 1 month\n * Systemic corticosteroids \\> 10 mg/day (prednisone equivalent), T-cell-targeted therapy (e.g., mycophenolate mofetil, calcineurin inhibitors), immunosuppressive agents, or antimalarial agents within 7 days\n * Prior anti-CD19 therapy\n * Prior T-cell-based cellular therapy or gene therapy, including CAR-T therapy\n* Current or prior malignancy\n* Known hypersensitivity to study-related agents\n* Pregnant or breastfeeding women\n* Active antiphospholipid syndrome (stable antiphospholipid antibody positivity without active APS is permitted)\n* Participation in another clinical trial at the time of screening\n* Any condition that, in the investigator's judgment, would interfere with protocol compliance or study participation"}, 'identificationModule': {'nctId': 'NCT07432334', 'briefTitle': 'CD19 CAR T-Cell Therapy for Refractory Systemic Lupus Erythematosus', 'organization': {'class': 'OTHER', 'fullName': 'Vinmec Research Institute of Stem Cell and Gene Technology'}, 'officialTitle': 'Evaluation of the Safety and Efficacy of CD19 CAR T-Cell Therapy for the Treatment of Refractory Systemic Lupus Erythematosus: A Phase I Clinical Trial', 'orgStudyIdInfo': {'id': 'ISC25.03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CD19 CAR-T Cell Therapy', 'description': 'Participants will receive autologous CD19-targeted chimeric antigen receptor T-cell (CAR-T) therapy following leukapheresis and protocol-defined lymphodepleting chemotherapy. A single intravenous infusion of CD19 CAR-T cells will be administered, with subsequent safety monitoring and follow-up according to the study protocol.', 'interventionNames': ['Biological: Autologous CD19-Targeted CAR-T Cells']}], 'interventions': [{'name': 'Autologous CD19-Targeted CAR-T Cells', 'type': 'BIOLOGICAL', 'description': "Autologous chimeric antigen receptor T cells targeting CD19, manufactured from participants' peripheral blood T cells collected by leukapheresis. Cells are genetically modified ex vivo to express a CD19-specific CAR, expanded, and administered as a single intravenous infusion following protocol-defined lymphodepleting chemotherapy. Participants undergo post-infusion monitoring for safety and immunological effects according to the study protocol.", 'armGroupLabels': ['CD19 CAR-T Cell Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Hanoi', 'country': 'Vietnam', 'contacts': [{'name': 'Liem T Nguyen, PhD', 'role': 'CONTACT', 'email': 'liem.nt@vinuni.edu.vn', 'phone': '+84 986 565 015'}], 'facility': 'Vinmec Research Institute of Stem Cell and Gene Technology', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}], 'centralContacts': [{'name': 'Liem T Nguyen, PhD', 'role': 'CONTACT', 'email': 'liem.nt@vinuni.edu.vn', 'phone': '+84 986 565 015'}, {'name': 'Van T Hoang, PhD', 'role': 'CONTACT', 'email': 'van.ht@vinuni.edu.vn', 'phone': '+84 936 449 481'}], 'overallOfficials': [{'name': 'Liem T Nguyen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vinmec Research Institute of Stem Cell and Gene Technology, VinUniversity'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vinmec Research Institute of Stem Cell and Gene Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}