[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543162":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":47,"collaborators":20,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":20,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":20,"studyType":62,"phases":63,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"920th Hospital of Joint Logistics Support Force of People's Liberation Army of China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CAR-T Cells Therapy","EXPERIMENTAL","Subjects who meet the enrollment conditions will receive intravenous infusion of CAR-T cells after lymphodepletion.",[13],"Biological: CAR-T cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","CAR-T cells","CAR-T cells will be administered by vein. Before CAR-T infusion，patients will get a 3-5 days lymphodepletion therapy with fludarabine and cyclophosphamide.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Sanbin Wang, Doctor","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":29,"email":30},"CONTACT","13187424131","+86","sanbin1011@163.com",[32],{"facility":5,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Kunming","Yunnan","650000","China","CN",{"type":40,"coordinates":41},"Point",[42,43],102.71833,25.03889,{"lat":43,"lon":42},[46],{"name":23,"role":27,"phone":28,"phoneExt":29,"email":30},{"type":48,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100543162","phase-1-efficacy-and-safety-of-car-t-cells-therapy-for-chronic-or-refractory-primary-immune-thrombocytopenia-itp-100543162",false,"NCT06352281","Efficacy and Safety of CAR-T Cells Therapy for Chronic or Refractory Primary Immune Thrombocytopenia (ITP)","An Investigator-initiated Trial to Evaluate the Efficacy and Safety of CAR-T Cells Therapy in the Treatment of Chronic or Refractory Primary Immune Thrombocytopenia (ITP)","Inclusion Criteria:\n\n1. Willingness to complete the informed consent process and to comply with study procedures and visit schedule;\n2. Men and women aged 8-75;\n3. Participants diagnosed with chronic (\\>12 months duration) or refractory (a documented intolerance or insufficient response to the first and second line standard treatment of ITP) ITP;\n4. The results of physical, instrumental, and laboratory examination of patients not suggest any disease which may cause thrombocytopenia other than ITP;\n5. Platelet count \\\u003C30 x 109 \u002F L;\n6. If the patient is taking corticosteroids, the treatment regimen\u002Fdose should be stable (at least 2 weeks prior to screening);\n7. The results of physical, instrumental, and laboratory examination of patients should be within the normal range or deviations should be regarded by the researcher as clinically insignificant;\n8. Willingness to use effective and reliable methods of contraception throughout the entire study period;\n\nExclusion Criteria:\n\n1. All subjects with diseases which may cause secondary immune thrombocytopenia\n2. Patients with preventive splenectomy;\n3. Hemostatic disorders other than chronic thrombocytopenia;\n4. Subject treated with drugs that affect platelet function (including but not limited to aspirin, clopidogrel and\u002For NSAIDs) or anti-coagulants for \\> 3 consecutive days within 2 weeks of the study start and until the end of the study;\n5. History of platelet agglutination abnormality that prevents reliable measurement of platelet counts;\n6. Concurrent malignant disease and\u002For history of cancer treatment with cytotoxic chemotherapy and\u002For radiotherapy;\n7. Grade III-IV heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically prominent heart disease within one year prior to enrollment;\n8. History of thrombosis or presence of significant risk factors for thrombosis;\n9. Persons with acute or exacerbation of chronic diseases of the gastrointestinal tract associated with the risk of bleeding, acute infectious diseases, pathologies of the respiratory system;\n10. Any clinically significant hepatic impairment (increase of serum transaminase levels by more than 3 times the upper limit of normal);\n11. Serum creatinine levels are more than two times higher than the upper limit of normal for a given age and sex;\n12. Any other concomitant decompensated diseases or acute conditions, the presence of which, according to the researcher, may significantly affect the results of the study;\n13. Human immunodeficiency virus (HIV) seropositivity, Hepatitis B surface antigen positive or hepatitis B core antibody positive and HBV-DNA positive, Patients with hepatitis C (HCV-RNA quantitative test results positive), Or the presence of other serious active viral or bacterial infections or uncontrolled systemic fungal infections;\n14. Patients with severe history of allergy or allergic constitution;\n15. Pregnancy and lactation;\n16. History of mental illness and known alcohol\u002Fdrug addiction;\n17. Poor compliance due to physiological, family, social, geographical and other factors, unable to cooperate with the study protocol and follow-up plan;\n18. Had undergone other clinical trials in the 4 weeks prior to participating in this trial;","ALL","8 Years","75 Years",{"count":60,"type":61},10,"ESTIMATED","INTERVENTIONAL",[64,65],"PHASE1","PHASE2","It is a single-center, single-arm, open-labeled clinical trial to evaluate the efficacy and safety of CAR-T cells therapy for Chronic or Refractory Primary Immune Thrombocytopenia (ITP).",[68],"ITP - Immune Thrombocytopenia",[70,71],"CAR-T","Immune Thrombocytopenia (ITP)","2024-07-18",{"date":74,"type":75},"2024-07-22","ACTUAL",{"date":77,"type":75},"2024-02-01",{"date":79,"type":61},"2027-12-31",{"name":5,"class":6},1]