[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"evans-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:evans-syndrome":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,75],{"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":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":5},"100606433","phase-1-a-study-of-cm336-in-patients-with-relapsed-or-refractory-autoimmune-cytopenia-100606433","NCT07175493","A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia","A Phase 1\u002F2 Clinical Study of CM336 Injection in Patients With Relapsed or Refractory Autoimmune Cytopenia","Inclusion Criteria:\n\n* Voluntary provision of written informed consent and ability to comply with protocol requirements.\n* Age ≥18 years, male or female.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.\n* Confirmed diagnosis of immune thrombocytopenia (ITP), warm autoimmune hemolytic anemia (wAIHA), cold agglutinin disease (CAD), mixed autoimmune hemolytic anemia (mAIHA) or Evans Syndrome.\n* Relapsed or refractory autoimmune hemolytic anemia.\n\nExclusion Criteria:\n\n* Secondary ITP or AIHA caused by any reason. Subjects with positive autoimmune antibodies but without a clear diagnosis of any other autoimmune diseases are allowed to be enrolled.\n* Other types of AIHA or other types of cytopenia\n* History of critical diseases that, in the opinion of the investigator, may pose a risk to the safety of subjects or whose exacerbation during the study could compromise the efficacy or safety analysis of the results.\n* Received any treatment of anti-B Cell Maturation Antigen(BCMA) antibody.\n* Evaluated unsuitable to participant in this study by investigator.",{"count":57,"type":21},158,[59,60],"PHASE1","PHASE2","To evaluate the efficacy and safety of CM336 (BCMA\u002FCD3 Bispecific Antibody) in the treatment of patients with relapsed or refractory autoimmune cytopenia",[63,64,27,29],"Autoimmune Cytopenia","Immune Thrombocytopenia (ITP)","2025-12-09",{"date":67,"type":40},"2025-12-17",{"date":69,"type":40},"2025-11-18",{"date":71,"type":21},"2028-11-18",{"name":73,"class":74},"Keymed Biosciences Co.Ltd","INDUSTRY",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":83,"enrollmentInfo":84,"targetDuration":86,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},"100511314","obscerevance-french-cohort-of-pediatric-autoimmune-cytopenia-100511314","NCT05937828","OBS'CEREVANCE: French Cohort of Pediatric Autoimmune Cytopenia","\"French National Cohort of Patients With Pediatric-onset of Autoimmune Cytopenia (OBS'CEREVANCE Cohort)\"","OBS'CEREVANCE","Inclusion Criteria:\n\n* Diagnosis of ITP, AIHA, Evans Syndrome\n* Onset before the age of 18\n\nExclusion Criteria:\n\n* Opposition of legal representative or to data collection","17 Years",{"count":85,"type":21},3500,"19 Years","OBSERVATIONAL","From 2004, OBS'CEREVANCE is a national real-world prospective clinical cohort of patients with auto-immune cytopenia of pediatric-onset : Immune thrombocytopenia (ITP), Autoimmune Hemolytic anemia (AIHA), or Evans syndrome (all bi or tri cytopenias). Thanks to the collaboration of the 30 French pediatric hematologic centers, this cohort supports all of the Rare Disease Centre CEREVANCE (Centre de Référence National des Cytopénies Auto-Immunes de l'Enfant) missions for care, education and research. Specifically, this original unbiased database allows to describe the long-term health of adult patients, to identify the heterogenous genetic underlying pathophysiologic contexts, and to study the benefit-risk balance of treatments, including the growing development of targeted therapies.",[90,27,29],"Immune Thrombocytopenia","2023-07-07",{"date":93,"type":40},"2023-07-10",{"date":95,"type":40},"2010-09-01",{"date":97,"type":21},"2029-12-31",{"name":99,"class":47},"University Hospital, Bordeaux",9]