Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2025-12-29 @ 1:21 PM
Study NCT ID:
NCT07193667
Status:
RECRUITING
Last Update Posted:
2025-09-26
First Post:
2025-09-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CAR-T in Subjects With Relapsed/Refractory Autoimmune Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001327', 'term': 'Autoimmune Diseases'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2025-09-15', 'studyFirstSubmitQcDate': '2025-09-24', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'chimeric status', 'timeFrame': '1 year after transplantation', 'description': "Detecting the chimerism in recipients' peripheral blood and bone marrow.Chimerism is generally measured in percentages(%)"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CAR-T'], 'conditions': ['Relapsed/Refractory Autoimmune Diseases']}, 'descriptionModule': {'briefSummary': 'In this study, CD19 CAR-T cells were administered to patients with relapsed/refractory autoimmune diseases. This study intends to use retroviral vector-based tandem CAR-T cells targeting CD19 to treat autoimmune disease. The CAR-T cells were provided by Shenzhen Cell Valley. A study published in the New England Journal of Medicine provides strong evidence for the therapeutic potential of CD19 CAR-T therapy in autoimmune diseases. The study enrolled 15 participants, including eight with severe SLE, three with idiopathic inflammatory myositis, and four with systemic sclerosis. The median follow-up was 15 months (4 to 29 months). Data from the clinical trial showed that all patients with SLE had a remission of DORIS, all patients with idiopathic inflammatory myositis had an ACR-EULAR major clinical response, all patients with systemic sclerosis had a decrease in the EUSTAR activity index score, and all patients discontinued immunosuppressive therapy completely. The investigators look forward to expanding the use of CAR-T cells in relapsed/refractory autoimmune diseases through this safety and efficacy clinical study and greatly enhancing the quality of life for these patients.', 'detailedDescription': 'This is a prospective, single-center, open, single-arm, dose-escalation clinical trial to evaluate the safety and efficacy of CAR-T cell therapy in patients with relapsed/refractory autoimmune diseases. Intravenous infusion will be used, and the trial procedure will be divided as follows:\n\n1. Screening period (D-28 to D-6):\n\n After subjects voluntarily sign an informed consent form, a screening period will be conducted to determine whether subjects are eligible for the trial based on inclusion and exclusion criteria.\n2. Lymphocyte depletion pretreatment (Study D-5 to Study D-3):\n\n Subjects will be pre-treated with Lymphocyte depletion starting 5 days prior to CAR-T cell infusion (FC regimen)\n3. Rest and Observation (Study D-2 to Study D-1):\n\n Follow the study procedures and perform the relevant examinations during the rest and observation period.\n4. Cell Infusion and Primary Study Endpoint Observation Period (Study D0 to W12 post-infusion):Subjects will undergo CAR-T cell infusion at 2-day intervals (Study Day 0) after lymphocyte depletion pretreatment, and post-infusion observations and safety assessments will be performed before, during, and after the cell infusion (day of infusion, days 4, 7, 10, 14, 21, and 28 post-infusion), respectively. Evaluation of efficacy: Subjects will be evaluated for efficacy on the 14th, 28th day, 8th and 12th week after CAR-T cell infusion.\n5. Follow-up period (W12 to W52 after infusion):The follow-up period is for safety and efficacy evaluation. Safety follow-up: Subjects will be followed for 52 weeks after CAR-T cell infusion. Efficacy Evaluation: Subjects will be evaluated for efficacy at weeks 24, 36, and 52 after CAR-T cell infusion. In addition, the actual frequency of effectiveness evaluations may be increased at the discretion of the investigator.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age 18-65 years (including threshold) and gender;\n* positive expression of CD19 in peripheral blood B cells as determined by flow cytometry;\n* the function of vital organs meets the following requirements:\n\n 1. Bone marrow function needs to meet the following requirements: a. White blood cell count ≥3×109/L; b. Neutrophil count ≥1×109/L (no colony-stimulating factor treatment within 2 weeks prior to the examination); c. Hemoglobin ≥60g/L;\n 2. Liver function: ALT≤3×ULN (except for elevated ALT caused by inflammatory myopathy); AST≤3×ULN (except for AST elevation caused by inflammatory myopathy); TBIL≤1.5×ULN (except for Gilbert's disease).\n\n TBIL≤1.5×ULN (except Gilbert's syndrome, total bilirubin≤3.0×ULN);\n 3. Renal function: creatinine clearance (CrCl) ≥ 30 ml/minute (Cockcroft/Gault formula, except for disease-induced decline in CrCl);\n 4. Coagulation: international normalized ratio (INR) ≤ 1.5 x ULN, prothrombin time (PT) ≤ 1.5 x ULN.\n 5. Cardiac function: hemodynamic stability;\n* female subjects of childbearing potential and male subjects with a partner of childbearing potential are required to use medically approved contraception or be abstinent from sexual intercourse for at least 6 months during and after study treatment; female subjects of childbearing potential must have had a negative serum HCG test within 7 days prior to study enrollment and must not be breastfeeding;\n* Voluntarily participate in this clinical study and sign the informed consent form, good compliance and cooperate with follow-up visits.\n* Specific inclusion criteria:\n* Relapsed refractory systemic lupus erythematosus.\n* meets the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE;\n* have a Disease Activity Score SLEDAI⁃2000 ≥ 6; and have at least one British Isles Lupus Assessment Group Index (BILAG-2004) Category A (severe manifestations) or two Category B (moderate manifestations) organ scores, or both; or have a Disease Activity Score SLEDAI-2000 ≥ 8;\n* Definition of relapse-refractory: failure of conventional treatment for more than 6 months or recurrence of disease activity after remission.\n* Relapsing Refractory/Progressive Diffuse Systemic Sclerosis\n* meets the 2013 ACR's classification criteria for systemic sclerosis consistent with a diffuse presentation\n* is positive for antibodies related to systemic sclerosis;\n* diffuse cutaneous sclerosis manifestations or active interstitial lung disease (HRCT suggestive of ground-glass exudates);\n* definition of relapsing-refractory: failure of conventional treatment for more than 6 months or recurrence of disease activity after remission.\n* Definition of Progressive: Rapid cutaneous progression (\\>25% increase in mRSS); or pulmonary progression (10% decrease in FVC, or \\>5% decrease in FVC with 15% decrease in DLCO).\n* Note: It is sufficient if one of Articles 4 and 5 is fulfilled.\n* Relapsed refractory/progressive inflammatory myopathy\n* meets the 2017 EULAR/ACR classification criteria for inflammatory myopathies (including DM , PM, ASS, and NM);\n* is positive for antibodies to myositis;\n* in those with muscle involvement, an MMT-8 score of less than 142 and abnormal findings on at least two of the following five core measurements (PhGA, PtGA, or Extramuscular Disease Activity Score ≥2; Total HAQ Score ≥0.25); Myosin level 1.5 times the upper limit of the normal range); or MMT-8 ≥142 in the presence of active interstitial lung disease (HRCT suggestive of ground-glass exudates);\n* Definition of relapse refractory: failure of conventional treatment for more than 6 months or recurrence of disease activity after remission.\n* Definition of progressive: the presence of exacerbation of myositis or rapidly progressive interstitial pneumonia.\n* Note: It is sufficient if one of Articles 4 and 5 is fulfilled.\n* Relapsed Refractory/Progressive Immune Thrombocytopenia\n* meets the 2019 American Society of Hematology (ASH) classification criteria for immune thrombocytopenia;\n* have bone marrow morphology characterized by increased or normal megakaryocytes with impaired maturation;\n* exclude other secondary thrombocytopenia\n* Definition of recurrent refractory: a patient who fails to achieve a satisfactory outcome after first-line standard therapy (e.g., glucocorticoids), including a full dose and course of therapy, i.e., platelet counts that cannot be maintained at a safe level (generally considered to be platelet counts \\> 30 × 10⁹ /L and without overt bleeding symptoms).\n* Definition of progressive: a sustained decline in platelet count over the course of the disease, or a progressive worsening of bleeding symptoms, which may be accompanied by signs such as splenomegaly, and a progressively worse response to conventional therapy.\n* Note: It is sufficient if one of Articles 4 and 5 is fulfilled.\n\nExclusion Criteria:\n\n* A history of severe drug allergies or sensitivities;\n* the presence or suspicion of fungal, bacterial, viral or other infections that are uncontrolled or require treatment\n* persons with central nervous system disorders caused by ADs or not caused by ADs.\n* those with intolerable cardiac function;\n* subjects with congenital immunoglobulin defects.\n* history of malignant tumors within the last five years.\n* end-stage renal failure;\n* subjects with positive Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA titer higher than the upper limit of the test; subjects with positive antibody to Hepatitis C virus (HCV) and peripheral blood HCV RNA; subjects with positive antibody to Human Immunodeficiency Virus (HIV); and subjects with a positive test for Syphilis;\n* mental illness and severe cognitive impairment;\n* have participated in other clinical trials within 3 months prior to enrollment;\n* immunosuppressants or biologics with a therapeutic effect for the indication within five half-lives prior to enrollment\n* women who are pregnant or intend to become pregnant;\n* subjects who, in the opinion of the investigator, have other reasons for not being included in the study."}, 'identificationModule': {'nctId': 'NCT07193667', 'briefTitle': 'CAR-T in Subjects With Relapsed/Refractory Autoimmune Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'ShenZhen Cell Valley'}, 'officialTitle': 'CAR-T Cell Therapy in Relapsed/Refractory Autoimmune Diseases', 'orgStudyIdInfo': {'id': '2024-757-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'relapsed/refractory autoimmune diseases', 'interventionNames': ['Drug: CD19 CAR-T cells were administered to patients with relapsed/refractory autoimmune diseases']}], 'interventions': [{'name': 'CD19 CAR-T cells were administered to patients with relapsed/refractory autoimmune diseases', 'type': 'DRUG', 'description': 'This is a prospective, single-center, open, single-arm, dose-escalation clinical trial to evaluate the safety and efficacy of CAR-T cell therapy in patients with relapsed/refractory autoimmune diseases. Intravenous infusion will be used, and the trial procedure will be divided as follows:\n\n1. Screening period (D-28 to D-6):\n\n After subjects voluntarily sign an informed consent form, a screening period will be conducted to determine whether subjects are eligible for the trial based on inclusion and exclusion criteria.\n2. Lymphocyte depletion pretreatment (Study D-5 to Study D-3):\n\n Subjects will be pre-treated with Lymphocyte depletion starting 5 days prior to CAR-T cell infusion (FC regimen)\n3. Rest and Observation (Study D-2 to Study D-1):\n\n Follow the study procedures and perform the relevant examinations during the rest and observation period.\n4. Cell Infusion and Primary Study Endpoint Observation Period (Study D0 to W12 post-infusion):Subjects will undergo CAR-T cell infusion at 2-da', 'armGroupLabels': ['relapsed/refractory autoimmune diseases']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110001', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'rui sun', 'role': 'CONTACT', 'email': 'sunrui@sz-cell.com', 'phone': '86+18810616095'}], 'facility': 'No. 155, The First Affiliated Hospital of China Medical University, Nanjing North Street, Heping District, Shenyang, Liaoning Province', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'rui sun', 'role': 'CONTACT', 'email': 'sunrui@sz-cell.com', 'phone': '86+18810616095'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'The study will run from August 2025 to August 2027.', 'ipdSharing': 'YES', 'description': 'Share IPD with The First Affiliated Hospital of China Medical University', 'accessCriteria': "The sponsors and collaborators are able to access the IPD and supporting information, IPD relies on team collaboration , as well as continuous improvement in innovation and efficiency. Participants will share project information, including the project's objectives, statistical datas, and clinical study report."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ShenZhen Cell Valley', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'First Affiliated Hospital of China Medical University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}