[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-immune-thrombocytopenic-purpura\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-immune-thrombocytopenic-purpura":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,78],{"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":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100626891","early-phase-1-ucar-t-targeting-cd19bcma-in-subjects-with-autoantibody-mediated-autoimmune-benign-hematological-diseases-100626891",false,"NCT07441525","UCAR-T Targeting CD19\u002FBCMA in Subjects With Autoantibody-Mediated Autoimmune Benign Hematological Diseases","Clinical Study on Safety, Efficacy, and Pharmacokinetics of Universal CAR-T Cell Injection Targeting CD19\u002FBCMA in Subjects With Autoantibody-Mediated Autoimmune Benign Hematological Diseases","Inclusion Criteria:\n\n* Subjects voluntarily participate in this trial and sign the informed consent form.\n* Aged ≥ 18 years and ≤ 75 years, regardless of gender.\n* Organ function and laboratory tests:\n\n  1. Liver function: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3 × Upper Limit of Normal (ULN); Total Bilirubin (TBIL) ≤ 2 × ULN (except for Gilbert's Syndrome).\n  2. Renal function: Creatinine ≤ 1.5 × ULN or Creatinine Clearance Rate ≥ 40 ml\u002Fmin.\n  3. Oxygen saturation (SpO2) ≥ 92% in room air at rest.\n  4. Echocardiography shows Left Ventricular Ejection Fraction (LVEF) ≥ 50%.\n* Female subjects of childbearing potential must have a negative result in serum or urine pregnancy test at screening.\n* Female subjects of childbearing potential must agree to use highly effective contraceptive methods from at least 28 days before the start of lymphodepletion to 12 months after reinfusion on RD06-05. Male subjects of childbearing potential must agree to use effective barrier contraceptive methods from the start of lymphodepletion to 12 months after reinfusion on RD06-05, and must not donate semen or sperm during the entire trial period.\n* Subjects with primary Immune Thrombocytopenia (ITP), with a disease duration of at least \\> 6 months.\n* Refractory or relapsed ITP: Subjects show no response, unsustained response, or intolerance to at least 2 different categories of standard treatments (e.g., glucocorticoids, splenectomy, intravenous immunoglobulin (IVIg), thrombopoietin receptor agonists (TPO-RA), Bruton's tyrosine kinase (BTK) inhibitors, etc.); among which, subjects must have received at least one or more treatments from IVIg, TPO-RA, or BTK inhibitors. In addition, platelet counts must be \\\u003C 30,000\u002FμL in two tests conducted within 15 days before the start of study treatment, with an interval of at least 7 days between the two tests.\n* Complete blood count: Neutrophil count ≥ 1,000\u002FµL, hemoglobin ≥ 60g\u002FL.\n* Subjects with Autoimmune Hemolytic Anemia (AIHA), including warm autoimmune hemolytic anemia (wAIHA), mixed autoimmune hemolytic anemia (mix-AIHA), and cold agglutinin disease (CAD), with a disease duration of at least \\> 6 months.\n* Refractory or relapsed AIHA: Subjects show no response, unsustained response, or intolerance to at least 3 lines of systemic treatments (e.g., glucocorticoids, rituximab, immunosuppressants, splenectomy, complement inhibitors, etc.).\n* Laboratory evidence of hemolysis: At least one of the following conditions exists in either the screening period or any test within the past 3 months: haptoglobin below the lower limit of normal, or total bilirubin (especially indirect bilirubin) above the upper limit of normal, or lactate dehydrogenase (LDH) above the upper limit of normal, and\u002For elevated reticulocyte count.\n* Complete blood count: Neutrophil count ≥ 1,000\u002FµL, hemoglobin (Hb) \\\u003C 100g\u002FL.\n* Diagnosed with Evans Syndrome (ES), with a disease duration of at least \\> 6 months.\n* Refractory or relapsed ES: After at least 3 lines of systemic treatments (e.g., glucocorticoids, intravenous immunoglobulin (IVIg), rituximab, immunosuppressants, splenectomy, thrombopoietin receptor agonists (TPO-RA), complement inhibitors, etc.), at least one type of cytopenia (thrombocytopenia or hemolytic anemia) still shows no response, unsustained response, or intolerance.\n* Laboratory evidence of active blood cell destruction: Platelet count \\\u003C 30,000\u002FμL or manifestations of hemolysis exist during the screening period or within the past 3 months, such as haptoglobin \\\u003C lower limit of normal, or total bilirubin (especially indirect bilirubin) \\> upper limit of normal, or LDH \\> upper limit of normal, and\u002For elevated reticulocyte count.\n* Definite response to at least one previous treatment:\n\nPlatelet (PLT) treatment response: Platelet count reaches ≥ 50,000\u002FμL in at least 2 tests, with an increase of ≥ 20,000\u002FμL compared to the baseline.\n\nHemoglobin (Hb) treatment response: Hb increases by ≥ 10-15 g\u002FL or hemolysis indicators improve.\n\nExclusion Criteria:\n\n* Has a coexisting autoimmune disease that may seriously interfere with the attribution of study disease activity or pose additional safety risks. However, if the subject's condition has been clinically stable for ≥ 3 months, and it is expected not to interfere with study assessments, the subject may be enrolled after confirmation by the investigator and approval by the sponsor's medical monitor (or their designee).\n* Has rapidly progressive glomerulonephritis (RPGN), defined as any of the following:\n\n  * Renal biopsy shows crescent formation in ≥ 50% of glomeruli.\n  * Sustained doubling of serum creatinine level within 2 months before screening.\n  * The investigator assesses that the subject has RPGN.\n* Subjects with the following cardiac diseases will be excluded:\n\n  * History of heart failure classified as New York Heart Association (NYHA) Class III or IV.\n  * History of myocardial infarction, cardiovascular angioplasty or stenting, unstable angina, or other serious cardiac diseases within 12 months before enrollment.\n* Has a history of severe central nervous system (CNS) diseases that may affect the subject's ability to comply with the study protocol or interfere with the accuracy of study assessments, such as: traumatic brain injury, disturbance of consciousness, epilepsy, cerebral vascular ischemia, or cerebral vascular hemorrhage.\n* Has a history of malignant tumors other than cured non-melanoma skin cancer or carcinoma in situ (e.g., carcinoma in situ of the cervix, bladder, or breast), unless the subject has been disease-free for at least 3 years.\n* Primary immunodeficiency.\n* Has uncontrolled infection; simple urinary tract infections and upper respiratory tract infections are permitted as judged by the investigator and the sponsor's medical monitor (or their designee).\n* Has a known history of infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or syphilis.\n* Active or latent hepatitis B virus (HBV) infection.\n* Positive results for Epstein-Barr virus (EBV) or cytomegalovirus (CMV) DNA or IgM antibodies during the screening period.\n* Has a history of recurrent tuberculosis or known recurrent tuberculosis.\n* Has a history of previous chimeric antigen receptor T-cell (CAR-T) therapy or any other genetically modified immune cell therapy.\n* Has received a live-attenuated vaccine within 4 weeks before enrollment.\n* Has a history of allergy to any component of the cell therapy product.\n* Has a history of hypersensitivity to tacrolimus, or has experienced ≥ Grade 3 tacrolimus-related toxicity in the past (including but not limited to neurological, gastrointestinal, hepatic, renal, or hematological toxicity), especially subjects who required hospitalization will be excluded. Other cases may be considered eligible after confirmation by the investigator and the sponsor's medical monitor (or their designee).\n* Has participated in another clinical trial within 30 days before screening.\n* Pregnant or lactating subjects, as well as subjects of childbearing potential who cannot take effective contraceptive measures.","ALL","18 Years","75 Years",{"count":20,"type":21},27,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","This is a single-arm, open-label, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of RD06-05 in subjects with autoantibody-mediated autoimmune hematological diseases. The enrolled population consists of patients with active autoimmune hematological diseases, including primary immune thrombocytopenic purpura (ITP), autoimmune hemolytic anemia (AIHA), and Evans syndrome.\n\nThis study sets two dose groups: 6 × 10⁶ CAR⁺T cells\u002Fkg and 10 × 10⁶ CAR⁺T cells\u002Fkg, with the initial dose being 6 × 10⁶ CAR⁺T cells\u002Fkg. To reduce efficacy risks, the dose may be escalated to 10 × 10⁶ CAR⁺T cells\u002Fkg following evaluation and recommendation by the Safety Review Committee (SRC). The SRC's recommendation on dose escalation will be based on a comprehensive assessment of all available safety, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy data.",[27,28,29],"Autoimmune Hemolytic Anemia","Primary Immune Thrombocytopenic Purpura","Evans Syndrome",[31,32,33,34,35],"UCART","CD19\u002FBCMA","ITP","AIHA","EVANS","RECRUITING","2026-02-24",{"date":39,"type":40},"2026-03-02","ACTUAL",{"date":42,"type":40},"2026-02-03",{"date":44,"type":21},"2029-06-30",{"name":46,"class":47},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":16,"minAge":17,"maxAge":57,"enrollmentInfo":58,"targetDuration":60,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":4},"100606992","ultrasound-to-detect-splenomegally-in-patients-with-isolated-thrombocytopenia-100606992","NCT07182760","Ultrasound to Detect Splenomegally in Patients With Isolated Thrombocytopenia","Clinicopathologic Significance of Splenomegally in Adult Patients With Isolated Thrombocytopenia","Inclusion Criteria:\n\n* patients more than 18 years admitted with isolated thrombocytopenia due to primary Immune thrombocytopenic purpura amegakaryocytic aplasia Unilineage myelodysplastic syndrome ( megakaryocyte dysplasia) lymphoproliferative disorder with secondary ITP autoimmune diseases with secondary ITP Willingness to participate in the study Admitted patients or those who follow at hematology outpatients clinic\n\nExclusion Criteria:\n\nEDTA induced pseudothrombocytopenia Platelet satellitism Drug induced thrombocytopenia Heparin induced thrombocytopenia \u002F thrombosis syndrome post transfusion purpura Disseminated intravascular coagulopathy patients less than 18 years old patients with bicytopenia or pancytopenia Pregnancy\n\n\\-",true,"65 Years",{"count":59,"type":21},100,"2 Years","OBSERVATIONAL","Investigate prevalence of splenomegally in patients with isolated thrombocytopenia.\n\nAsess effect of splenomegally in clinical picture ,Complication, treatment response and disease outcome To explain possible causes of splenomegally in patients with isolated thrombocytopenia",[28,64,65,66,67],"Amegakaryocytic Aplasia","Unilineage Myelodysplastic Syndrome ( Megakaryocyte Dysplasia)","Lymphoproliferative Disorder With Secondary ITP","Autoimmune Diseases With Secondary ITP","NOT_YET_RECRUITING","2025-09-13",{"date":71,"type":40},"2025-09-19",{"date":73,"type":21},"2025-10",{"date":75,"type":21},"2027-05",{"name":77,"class":47},"Assiut University",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":33,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":85,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":48},"100430819","tpo-ra-in-primary-immune-thrombocytopenia-itp-in-patients-older-than-14-years-100430819","NCT04890041","TPO-RA in Primary Immune Thrombocytopenia (ITP) in Patients Older Than 14 Years","Efficacy of TPO-RA in the Management of Primary Immune Thrombocytopenia (ITP) in Patients Older Than 14 Years With Poor First-line Response: a Multi-center, Prospective, One-arm Study","Inclusion Criteria:\n\n* Men and women greater than or equal to 14 years of age.\n* Participants diagnosed with primary immune thrombocytopenia with two platelet counts of \\\u003C 30x10\\^9\u002FL or with bleeding at least 7 days apart，do not have evidence of other causes of thrombocytopenia (e.g.,pseudothrombocytopenia, myeloid fibrosis).\n* Previous treatment with poor response to first-line therapy and any of the maximum 4-week doses of eltrombopag, herombopag, avatrombopag, or 300U\u002Fkg\u002F day × 14-day rhTPO with no response to treatment (platelet count \\\u003C 30×109\u002FL after treatment, or platelet count increase less than twice the baseline value, or with bleeding)\n* Participants willing and able to comply with the requirements of the study protocol, and sign the informed consent.\n\nExclusion Criteria:\n\n* Patients diagnosed with secondary immune thrombocytopenia.\n* A history of arteriovenous thrombosis, disseminated intravascular coagulation, myocardial infarction, cerebral obstruction, thrombotic microangiopaemia, autoimmune diseases, malignant tumors, liver cirrhosis and other diseases that were not eligible for inclusion.\n* Liver disease with one of the following indicators: a. total bilirubin ≥ 2 times of the upper limit of normal; b. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal value; Patients with renal disease (serum creatinine ≥ 1.5 times the upper limit of normal);\n* Subjects with known allergies to eltrombopag, herombopag, rh-TPO, avatrombopag, or any of excipients;\n* Have used rituximab in the past 3 months;\n* Splenectomy in recent 3 months;\n* Those who are not considered suitable for this study by the researcher;\n* Women who are pregnant or who intend to become pregnant in the near future are excluded.","14 Years",{"count":59,"type":21},[88],"NA","This multi-center study aims to study the efficacy of TPO-RAs' transformation in Chinese ITP patients older than 14 years. This study will be conducted in ITP patients who had not responded to first-line in the previous treatment .",[28],"2025-02-20",{"date":93,"type":40},"2025-02-24",{"date":95,"type":40},"2021-05-30",{"date":97,"type":21},"2025-12-31",{"name":99,"class":47},"Institute of Hematology & Blood Diseases Hospital, China"]