[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"autoimmune-thrombocytopenia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:autoimmune-thrombocytopenia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,85],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100557123","phase-1-iaso-782-in-autoimmune-hematological-diseases-100557123",false,"NCT06534021","IASO-782 in Autoimmune Hematological Diseases","A Phase Ia Study to the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IASO-782 in Patient With Autoimmune Hematological Diseases (Autoimmune Thrombocytopenia and Warm Antibody Type Autoimmune Hemolytic Anemia)","Inclusion Criteria:\n\n1. Age 18-65 years\n2. Clinically confirmed diagnosis of autoimmune thrombocytopenia (ITP) or warm autoimmune haemolytic anaemia (wAIHA)\n3. Failure or relapse after at least 1 treatment for the study disease\n4. Stable dose of immunosuppressants for 4 weeks before screening\n5. Organ function or laboratory test is basically normal\n6. Subjects of childbearing potential and their partners must use effective contraception for at least 2 weeks before administration of investigational product, throughout the trial period, and for 28 days after the end of the trial (or early termination of the trial)\n7. Females of potential childbearing capacity must have a negative pregnancy test at screening\n8. Voluntarily participate in this study and sign the informed consent\n\nExclusion Criteria:\n\n1. History of other primary malignant neoplasm within 5 years of screening\n2. Secondary to other disease-induced hematopoietic destruction\n3. Cardiac disorder within the last 3 months\n4. Patients with high blood pressure that cannot be controlled by drug\n5. Subjects with a history of allergy to any component of the investigational drug\n6. Active infection requiring intravenous treatment within 30 days prior to the enrollment\n7. Pregnant or breastfeeding women\n8. Participation was being given other investigational drug within 30 days or 5 half-lives (whichever is longer) prior to administration of the investigational drug\n9. Previous treatment drugs have not been adequately washed out\n10. ITP patients have had any previous arterial or venous thrombosis\n11. Patients with ITP had previous biopsy bone marrow results indicating bone marrow fibrosis (Myelofibrosis MF) ≥ 2\n12. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection, as described in the protocol\n13. Subjects with a history of drug abuse or mental disorder\n14. Other medical history or conditions that would make the subject unsuitable for the study by investigators' judge.","ALL","18 Years","65 Years",{"count":20,"type":21},16,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study is a randomized, double-blinded, and placebo-controlled phase Ia clinical study in subjects with autoimmune hematological diseases. The study is designed to assess the safety and tolerability of IASO-782 for the treatment of autoimmune haematological diseases (ITP and wAIHA).",[27,28],"Autoimmune Thrombocytopenia","Warm Autoimmune Haemolytic Anaemia","RECRUITING","2026-05-26",{"date":32,"type":33},"2026-05-29","ACTUAL",{"date":35,"type":33},"2024-08-08",{"date":37,"type":21},"2027-12-31",{"name":39,"class":40},"Shanghai IASO Biotechnology Co., Ltd","INDUSTRY",2,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":17,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100431799","conception-of-a-diagnosis-prognosis-and-therapeutic-decision-tool-for-patients-with-autoimmunity-and-inflammation-100431799","NCT04902807","Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and Inflammation","ATRACTion","Inclusion Criteria for controls (patients relatives and unrelated subjects):\n\n* Individuals aged\\\u003C18 y\u002Fo.\n* Individuals \\> 6 kg\n* Individuals not affected by an immune-related disease or not affected by cancer\n* Individuals whose parents have signed an enlightened consent.\n\nInclusion criteria for patients\n\n* Individuals with health insurance.\n* Patients treated at Necker hospital with PIDs and autoimmunity\u002Finflammation related to known genetic defects (cytopenia, Enteropathy Inflammatory bowel disease (IBD), Systemic Lupus Erythematosus (SLE), Juvenile Idiopathic Arthritis (JIA), Familial Hemophagocytic Lymphohistiocytosis (FHL), chronic EBV infection associated (Ca-EBV) with EBV-infected T and\u002For Natural Killer (NK) cells and with a high risk to develop macrophage activation syndrome similar to FHL. See table below for diagnosis inclusion criteria.\n* Individuals aged\\\u003C18 y\u002Fo.\n* Individuals \\> 9 kg\n* Patients whose parents have signed an enlightened consent.\n\nExclusion Criteria:\n\n* Intake of antibiotics within 2 weeks prior inclusion\n* Absence of parent's or child consent form\n* Cytotoxic cancer treatments\n* antiviral treatments (HIV, hepatitis …)\n* Short term life-threatening conditions\n* Individuals placed under judicial protection","1 Year",{"count":51,"type":21},500,"OBSERVATIONAL","The main objective of this study is to generate diagnosis and therapeutic-decision tools through the identification of molecular causes of PIDs with autoimmunity\u002Finflammation and the variability in disease outcome at the transcriptional level using a combination of omics signatures (transcriptomics, epigenomics, proteomics, metagenomics, metabolomics and lipidomics).",[55,56,57,58,27,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73],"Autoimmune Lymphoproliferative Syndrome","Autoimmune Cytopenia","Autoimmune Diseases","Autoimmune Anemia","Autoimmune Hepatitis","Autoimmune Diabetes","Autoimmune Rheumatologic Disease","Systemic Lupus Erythematosus","Juvenile Idiopathic Arthritis","Hemophagocytic Lymphohistiocytoses","EBV Lymphoproliferation","RAS-Associated Autoimmune Leucoproliferative Disease","Primary Immunodeficiency","APECED","IPEX","BENTA","Enteropathy, Autoimmune","Combined Immunodeficiency","IBD","2025-09-02",{"date":76,"type":33},"2025-09-08",{"date":78,"type":33},"2021-09-07",{"date":80,"type":21},"2026-06",{"name":82,"class":83},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV",1,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":104,"locationsCount":84},"100579602","phase-1-inaticabtagene-autoleucel-injection-in-the-treatment-of-refractory-systemic-lupus-erythematosus-related-immune-thrombocytopenia-100579602","NCT06826430","Inaticabtagene Autoleucel Injection in the Treatment of Refractory Systemic Lupus Erythematosus-related Immune Thrombocytopenia","A Multi-center, Open-label, Single-arm Phase I Clinical Study to Evaluate the Safety and Tolerability of Inaticabtagene Autoleucel Injection in Treatment of Refractory Systemic Lupus Erythematosus-related Immune Thrombocytopenia","Inclusion Criteria:\n\n1. Age range: 18-70 years (including 18 and 70 years), regardless of gender.\n2. Clinically diagnosed with Refractory Systemic Lupus Erythematosus-related Immune Thrombocytopenia according to the revised criteria of ACR in 1997 or EULAR\u002FACR in 2019. At least two consecutive blood routine tests showing platelet counts \\\u003C50×10\\^9\u002FL; Peripheral blood smear microscopy showed no significant abnormalities in the morphology of blood cells; The morphological characteristics of bone marrow cells are consistent with immune thrombocytopenia. Treated at least 1 course of MP shock therapy or high-dose steroids, combined with one or more immunosuppressive agents (including biologics) for at least 3 months but not achieving partial remission, or the efficacy cannot be maintained during the steroid reduction process.\n3. During the study period, the use of corticosteroids at a dose not exceeding 10mg prednisone or its equivalent, all immunosuppressants (excluding hydroxychloroquine) should be discontinued.\n4. Women of childbearing potential must have a negative blood pregnancy test 7 days prior to trial conditioning therapy; any male and female patients of childbearing potential must agree to use an effective method of contraception throughout the study and for at least 2 year following infusion of CAR-T cells. Childbearing potential is biologically capable of bearing a living baby and sexually active. Female patients who were not of childbearing potential (ie, met at least 1 of the following criteria):\n\n   * Hysterectomy or oophorectomy, or\n   * Medically confirmed ovarian failure, or medically confirmed postmenopausal (cessation of menses for at least 12 consecutive months in the absence of pathological or physiological causes).\n5. Adequate organ function according to the following criteria:\n\n   * Aspartate aminotransferase (AST) ≤ 3 times of upper limit of normal (ULN);\n   * Alanine aminotransferase (ALT) ≤ 3 times ULN;\n   * Total serum bilirubin ≤ 2 times ULN unless the patient has documented Gilbert's syndrome; patients with Gilbert's syndrome who have bilirubin ≤ 3.0 times ULN and direct bilirubin ≤ 1.5 times ULN may be included;\n   * Serum creatinine ≤ 1.5 times ULN, or creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft and Gault formula), Patients with lupus nephritis may relax the conditions appropriately according to the judgment of the investigator;\n   * Must have minimal pulmonary reserve and oxygen saturation \\> 91% in a nonoxygenated state;\n   * Lymphocyte count \\> 0.4 × 109\u002FL.\n\nExclusion Criteria:\n\n1. Severe active central nervous system (CNS) lupus, including seizures, psychosis, cerebrovascular accidents, or CNS vasculitis requiring therapeutic intervention within 60 days after baseline.\n2. Dialysis patients or creatinine clearance rate less than 30mL\u002Fmin.\n3. Pregnancy or breastfeeding.\n4. Merge active infections (such as sepsis, bacteremia, mycosis, uncontrolled lung infections, and active tuberculosis).\n5. Hepatitis B surface antigen (HBsAg) and\u002For hepatitis B e antigen (HBeAg) are positive; Hepatitis B e antibody (HBe Ab) and\u002For hepatitis B core antibody (HBcAb) are positive, and the number of HBV-DNA copies is greater than the measurable lower limit; Hepatitis C (HCV) antibody positive; positive for human immunodeficiency virus (HIV) antibodies; positive for syphilis antibody (TP Ab);\n6. Major surgery that was assessed as unsuitable by the investigators within 4 weeks before screening.\n7. Patients with concurrent active malignancy within the past five years, those with a history of malignancy but cuired are eligible.\n8. The patient's heart meets any of the following conditions:\n\n   Left ventricular ejection fraction (LVEF) ≤ 45%; New York Heart Association (NYHA) Grade III or IV congestive heart failure or active heart disease; Severe arrhythmias that require treatment (excluding atrial fibrillation and paroxysmal supraventricular tachycardia); QTcB interval ≥ 450ms for males and ≥ 470ms for females (QTcB=QT\u002FRR1\u002F2); Have had myocardial infarction, bypass or stent surgery within the 6 months prior to the study; Other heart diseases that have been determined by researchers to be unsuitable for inclusion;\n9. Patients with clinically significant pleural effusion during screening.\n10. Patients vaccinated with a live vaccine within 6 weeks prior to screening.\n11. Patients with deep vein thrombosis within 6 months prior to screening, or a history of pulmonary embolism.\n12. Patients with a life expectancy of less than 6 months.\n13. Patients participating in any other interventional clinical study or receiving treatment of an active investigational drug within 3 months or 5 half-lives for launched drugs prior to Inaticabtagene Autoleucel Injection infusion.\n14. Patients with a history of epilepsy, cerebral ischemia\u002Fhemorrhage, cerebellar diseases, or other active central nervous system disorders;\n15. Patients with hypersensitivity reactions to the components of Inaticabtagene Autoleucel Injection.\n16. Patients previously received CAR-T cell therapy.","70 Years",{"count":94,"type":21},12,[24],"This is a single-arm, open-label，phase I clinical study to evaluate the safety and tolerability of Inaticabtagene Autoleucel Injection in treatment of refractory systemic lupus erythematosus-related immune thrombocytopenia.",[27],"2025-08-06",{"date":100,"type":33},"2025-08-07",{"date":102,"type":33},"2025-03-01",{"date":37,"type":21},{"name":105,"class":40},"Juventas Cell Therapy Ltd."]