[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ShenZhen Cell Valley\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100607831","car-t-in-subjects-with-relapsedrefractory-autoimmune-disease-100607831",false,"NCT07193667","CAR-T in Subjects With Relapsed\u002FRefractory Autoimmune Disease","CAR-T Cell Therapy in Relapsed\u002FRefractory Autoimmune Diseases","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\u002FL; b. Neutrophil count ≥1×109\u002FL (no colony-stimulating factor treatment within 2 weeks prior to the examination); c. Hemoglobin ≥60g\u002FL;\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\u002Fminute (Cockcroft\u002FGault 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\u002FAmerican College of Rheumatology (EULAR\u002FACR) 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\u002FProgressive 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\u002Fprogressive inflammatory myopathy\n* meets the 2017 EULAR\u002FACR 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\u002FProgressive 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 \u002FL 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.","ALL","18 Years","65 Years",{"count":20,"type":21},3,"ESTIMATED","INTERVENTIONAL",[24],"NA","In this study, CD19 CAR-T cells were administered to patients with relapsed\u002Frefractory 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\u002Frefractory autoimmune diseases through this safety and efficacy clinical study and greatly enhancing the quality of life for these patients.",[27],"Relapsed\u002FRefractory Autoimmune Diseases",[29],"CAR-T","RECRUITING","2025-09-24",{"date":33,"type":34},"2025-09-26","ACTUAL",{"date":36,"type":21},"2025-10",{"date":38,"type":21},"2027-12",{"name":40,"class":41},"ShenZhen Cell Valley","INDUSTRY",""]