[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"autoimmune-hemolytic-anemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:autoimmune-hemolytic-anemia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,41,65,91,113,142,166,189,213,230,252,277,297,319,348,371,397,417,457,481,504],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100639328","phase-2-study-of-zola-cel-bms-986353-in-participants-with-autoimmune-cytopenia-breakfree-aice-100639328",false,"NCT07603557","Study of Zola-cel (BMS-986353), in Participants With Autoimmune Cytopenia (Breakfree-AiCE)","A Phase 2, Multicenter, Open-Label Study of Zolacabtagene Autoleucel (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants With Chronic Immune Thrombocytopenia (cITP) and Autoimmune Hemolytic Anemia (AIHA)","Inclusion Criteria\n\nInclusion Criteria for ITP\n\n* Documented clinical diagnosis of chronic ITP (cITP) without other clinical manifestations of systemic autoimmune disease.\n* Has relapsed after or is intolerant to corticosteroids (with or without intravenous immunoglobulin (IVIG) or anti-Rh0(D) Ig) AND has failed, relapsed after, or is intolerant to therapies with ≥ 2 mechanisms of action, with at least one being immunosuppressive or immunomodulatory.\n\nPlatelet count \\\u003C 30 × 109\u002FL. For participants on thrombopoietin receptor agonist (TPO-RA): platelet count \\\u003C 50 × 109\u002FL.\n\nInclusion Criteria for AIHA\n\n* Documented clinical diagnosis of AIHA (including warm autoimmune hemolytic anemia (wAIHA), cold agglutinin disease (CAD), or mixed AIHA) without other clinical manifestations of systemic autoimmune disease.\n\n  o wAIHA and mixed warm and cold AIHA: Failed, relapsed after, or is intolerant to at least 2 prior lines of treatment with 2 mechanisms of action (not including corticosteroids or IVIG), one of which is an anti-CD20 monoclonal antibody unless there is a documented contraindication.\n\n  o CAD (all of the following must apply): Failed, relapsed after, or is intolerant to at least 2 prior lines of treatment with 2 mechanisms of action, one of which is an anti-CD20 monoclonal antibody with or without chemotherapy unless there is a documented contraindication.\n* Hb \\\u003C10 g\u002FdL without red blood cell transfusion, or transfusion dependent\n* Documented hemolysis\n\nExclusion Criteria\n\nMedical Conditions\n\n* ITP or AIHA associated with: Evans syndrome, other systemic autoimmune disease or single organ autoimmune disease requiring systemic immunosuppressive therapy, hepatitis C virus, HIV, drug induced (eg, non-steroidal anti-inflammatory drug (NSAIDS), trimethoprim\u002Fsulfamethoxazole (TMP-SMX), anticonvulsants), surgical procedures, or hematologic malignancies.\n* COVID-19 Vaccine-induced immune thrombotic thrombocytopenia\n* Prior history of solid organ malignancies, unless the participant has been free of the disease for ≥ 2 years.\n\nLaboratory Test Findings\n\n* Peripheral blood ANC \\\u003C 1.5 × 109\u002FL or requiring G-CSF or GM-CSF support o ALT\u002FAST: ITP: ALT\u002FAST: \\> 3 × ULN AIHA: ALT \\> 3 ULN. AST up to 5 × ULN may be permitted. o Bilirubin: ITP: total bilirubin \\> 1.5 × ULN AIHA: direct bilirubin \\> 1.5 × ULN o International normalized ratio (INR) \\> 1.5 × ULN\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years",{"count":19,"type":20},52,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this study is to evaluate the safety and efficacy of Zola-cel (BMS-986353), in participants with chronic immune thrombocytopenia (cITP) and autoimmune hemolytic anemia (AIHA).",[26,27],"Chronic Immune Thrombocytopenia","Autoimmune Hemolytic Anemia","NOT_YET_RECRUITING","2026-05-18",{"date":31,"type":32},"2026-05-22","ACTUAL",{"date":34,"type":20},"2026-06-15",{"date":36,"type":20},"2030-05-06",{"name":38,"class":39},"Juno Therapeutics, Inc., a Bristol-Myers Squibb Company","INDUSTRY",8,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":60,"leadSponsor":62,"locationsCount":4},"100639831","phase-1-iaso206-in-patients-with-relapsedrefractory-autoimmune-hemolytic-anemia-100639831","NCT07585071","IASO206 in Patients With Relapsed\u002FRefractory Autoimmune Hemolytic Anemia","Phase I Clinical Study on the Safety and Tolerability of IASO206 Injection in Patients With Relapsed\u002FRefractory Autoimmune Hemolytic Anemia","Inclusion Criteria:\n\n* Age 18 to 75 years, gender unrestricted.\n* Diagnosis of AIHA (including warm antibody type, warm-cold antibody type, cold agglutinin disease) or Evans syndrome, consistent with Chinese Expert Consensus on Diagnosis and Treatment of Autoimmune Hemolytic Anemia (2023), 2019 International Consensus for Diagnosis and Management of Autoimmune Hemolytic Anemia (Blood Rev, 2020), or Chinese Expert Consensus on Diagnosis and Treatment of Evans Syndrome (2024 Edition).\n* Patients with relapsed\u002Frefractory disease after multiple lines of therapy must meet all of the following criteria: hemoglobin \\\u003C 10 g\u002FdL with clinical manifestations of hemolytic anemia; prior treatment with at least 2 immunosuppressive drugs (must include CD20 monoclonal antibody); glucocorticoid therapy for at least 3 months (excluded are patients with contraindications to glucocorticoids, severe infection, severe osteoporosis, previous fracture, or inability to tolerate glucocorticoids); cumulative dose of CD20 monoclonal antibody at least 375 mg\u002Fm² × 4, or total dose 2.0 g, or at least 6 administrations (at least 1 week apart each time).\n* ECOG score ≤ 2.\n* Expected survival time ≥ 12 weeks.\n* Adequate organ function confirmed by laboratory tests: serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × upper limit of normal (ULN); minimum pulmonary reserve defined as grade ≤ 1 dyspnea and oxygen saturation ≥ 93% without oxygen supplementation; creatinine clearance (estimated by Cockcroft-Gault) ≥ 45 mL\u002Fmin; cardiac ejection fraction ≥ 50%, no pericardial effusion on echocardiogram (ECHO), and no clinically significant abnormal electrocardiogram (ECG).\n* Subjects and their partners agree to use effective barrier or medical contraceptive measures (excluding rhythm method) from signing informed consent until 1 year after administration.\n* Subjects must provide written informed consent approved by the Ethics Committee prior to initiation of screening procedures\n\nExclusion Criteria:\n\n* Subject with confirmed lymphoproliferative neoplasms.\n* Subject with secondary AIHA induced by drugs or infection.\n* Subject with congenital immunodeficiency diseases, other hereditary or acquired hemolytic diseases.\n* Subject with a history of organ or stem cell transplantation.\n* Subject with a history of organ infarction within the past 6 months.\n* Subject who have received prior BCMA-targeted therapy.\n* Subject who received plasma cell-targeted cell therapy within 3 months before screening, or in whom prior cell therapy products are still detectable in peripheral blood.\n* Subject who received any of the following treatments within the specified periods prior to study enrollment:\n\n  1. Anti-CD20 monoclonal antibody \\\u003C 12 weeks;\n  2. Sutimlimab or other marketed biological products \\\u003C 5 half-lives;\n  3. Plasma exchange \\\u003C 4 weeks;\n  4. Splenectomy \\\u003C 12 weeks.\n* Subject with any of the following cardiovascular diseases:\n\n  1. Left ventricular ejection fraction (LVEF) ≤ 45%;\n  2. Active heart disease or congestive heart failure (New York Heart Association \\[NYHA\\] Class III or IV);\n  3. Severe arrhythmia requiring treatment (excluding atrial fibrillation, paroxysmal supraventricular tachycardia);\n  4. QTcB interval ≥ 450 ms for males, ≥ 470 ms for females;\n  5. Myocardial infarction, bypass surgery, or stent implantation within 6 months before study;\n  6. Other cardiac diseases judged by the investigator to be unsuitable for enrollment.\n* Unstable systemic diseases judged by the investigator, including but not limited to severe hepatic or renal diseases requiring medical treatment.\n* Subject with a history of other primary malignancies within 5 years before screening, except:\n\n  1. Resected and cured non-melanoma skin cancer (e.g., basal cell carcinoma);\n  2. Cured carcinoma in situ (e.g., cervical, bladder, or breast cancer);\n  3. Other primary cancers with no evidence of recurrence for more than 5 years after treatment.\n* Subject who underwent major surgery within 4 weeks before screening and are judged unsuitable for enrollment by the investigator.\n* Subject with uncontrolled active fungal, viral, bacterial, mycobacterial, or other infections (persistent infection-related signs\u002Fsymptoms without improvement after appropriate anti-infective therapy) or infections requiring intravenous anti-infective therapy.\n* Positive hepatitis B surface antigen (HBs-Ag) or hepatitis B e antigen (HBe-Ag); positive hepatitis B e antibody (HBe-Ab) or hepatitis B core antibody (HBc-Ab) with HBV-DNA copy number above the lower limit of quantification; positive hepatitis C (HCV) antibody; positive human immunodeficiency virus (HIV) antibody; active syphilis infection (excluding those with only positive syphilis-specific antibody).\n* Subject who received live viral vaccines within 4 weeks before enrollment.\n* Subject who are participating in other interventional clinical studies during IASO206 Injection treatment with a drug half-life \\\u003C 5; subject receiving active investigational drugs during the entire study period, or who intend to participate in another clinical trial, or receive treatments outside the protocol.\n* Pregnant or lactating females.\n* Subject with psychiatric disorders, disturbance of consciousness, or central nervous system diseases, including but not limited to epilepsy and Parkinson's disease.\n* Subject with hypersensitivity to components of IASO206 Injection or supportive medications required for the management of CAR-T therapy-related toxicities (e.g., tocilizumab).\n* Other conditions judged by the investigator to be unsuitable for enrollment.10. Other Information","75 Years",{"count":50,"type":20},18,[52],"PHASE1","This study is an open-label, single-arm early exploratory clinical study, aiming to evaluate the safety, tolerability and preliminary efficacy of IASO206 Injection (In Vivo CAR-T) in Patients with Relapsed\u002FRefractory Autoimmune Hemolytic Anemia",[27,55],"Relapsed\u002FRefractory","2026-05-06",{"date":58,"type":32},"2026-05-13",{"date":34,"type":20},{"date":61,"type":20},"2028-12-31",{"name":63,"class":64},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":89,"locationsCount":90},"100639998","brain-cognitive-network-abnormalities-in-anemia-patients-using-fnirs-100639998","NCT07578675","Brain Cognitive Network Abnormalities in Anemia Patients Using fNIRS","Construction of Abnormal Projection Regions of Cognitive Neural Networks in Patients With Anemia Using Functional Near-Infrared Spectroscopy (fNIRS)","AN-CNA","Inclusion Criteria:\n\n* Diagnosis of anemia\n* First hospitalization\n* Male or female, aged 18-65 years\n* Willing and able to comply with the requirements for this study and written informed consent\n\nExclusion Criteria:\n\n* History of psychiatric illness\n* History of severe brain disease\n* Subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study","65 Years",{"count":75,"type":20},323,"OBSERVATIONAL","Anemia is a global public health concern and is closely linked to dysfunction of brain cognitive neural networks, a key mechanism underlying cognitive impairment. Such deficits-including declines in memory, learning, processing speed, and executive function-reduce daily living abilities and increase risks of falls and depression.\n\nFunctional near-infrared spectroscopy (fNIRS) enables real-time monitoring of oxygenated and deoxygenated hemoglobin fluctuations, reflecting brain network function. This study aims to identify affected neural network regions in anemic patients and visualize connectivity changes using heatmaps and arc-based mapping. The findings will support early detection of cognitive impairment and guide precise clinical interventions, ultimately informing individualized treatment strategies to enhance therapeutic outcomes and quality of life.",[79,80,27,81],"Aplastic Anemia","Myelodysplastic Syndromes","Functional Near-Infrared Spectroscopy","RECRUITING","2026-05-05",{"date":85,"type":32},"2026-05-11",{"date":87,"type":32},"2025-10-11",{"date":61,"type":20},{"name":63,"class":64},1,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":90},"100627838","phase-1-research-on-yts109-cell-in-patients-with-recurrentrefractory-autoimmune-hemolytic-anemia-100627838","NCT07453836","Research on YTS109 Cell in Patients With Recurrent\u002FRefractory Autoimmune Hemolytic Anemia","The Safety and Efficacy of YTS109 Cell for Relapsed\u002FRefractory Autoimmune Hemolytic Anemia Patients After Receiving Three or More Lines of Therapy.","Inclusion Criteria:\n\n* 18 ≤ Age ≤ 60 years, regardless of gender.\n* A definitive diagnosis of Autoimmune Hemolytic Anemia (AIHA) or Evans Syndrome \\[including warm antibody-type, mixed warm-cold antibody-type, and cold antibody-type hemolytic anemia (cold agglutinin disease)\\] has been established, with diagnostic criteria referenced from the Chinese Clinical Practice Guidelines for the Diagnosis and Treatment of Autoimmune Hemolytic Anemia in Adults (2023 Edition).\n* Patients who have undergone at least three failed treatment attempts, whose anemia symptoms (hemoglobin \\\u003C 100 g\u002FL) persist despite conventional therapy, and who remain unresponsive or experience recurrence after disease remission. Definition of Conventional Therapy: Treatment with glucocorticoids and\u002For rituximab, combined with any one or more of the following interventions: splenectomy, cyclosporine, cyclophosphamide, azathioprine, mycophenolate mofetil, bendamustine, fludarabine, bortezomib, or other pharmacological agents, as well as biologic agents including anti-CD38 monoclonal antibodies, BTK inhibitors, Syk inhibitors, complement inhibitors, etc.\n* Adequate Organ Function:\n\n  1. Liver Function:\n\n     Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN); Total bilirubin ≤ 2.0 × ULN (excluding Gilbert syndrome, where total bilirubin ≤ 3.0 × ULN).\n  2. Renal Function:\n\n     Creatinine clearance (CrCl) ≥ 60 ml\u002Fminute (calculated using the Cockcroft-Gault formula).\n  3. Oxygen Saturation (SpO₂): ≥ 92%.\n* ECOG performance status≤2.\n* Subjects of childbearing potential will be required to follow contraception requirements from the time of enrollment until the end of the 12-month safety follow-up period.\n* The subjects voluntarily participate in the study, sign the informed consent, demonstrate good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n* Diagnosis of lymphoproliferative tumor\n* Other hereditary or acquired hemolytic diseases (Secondary AIHA caused by drugs or infection)\n* The platelet count in peripheral blood\\\u003C30×10\\^9\u002FL\n* Pregnant or breast-feeding subjects\n* Receive any of the following treatments within the specified time before cell infusion: a.anti-CD20 monoclonal antibodies \\\u003C12 weeks, b.sutimlimab or other marketed biologics \\\u003C5 half-lives,c.plasma exchange \\\u003C4 weeks, d.post-splenectomy \\\u003C12 weeks, e. BTK inhibitors, anti-CD38 monoclonal antibody, Syk inhibitors, BAFF inhibitors \\\u003C 5 half-lives.\n* Previously received organ or stem cell transplantation\n* History of new thrombosis or organ infarction in the past 6 months\n* Diagnosis of the active stage of the connective tissue disease.\n* Have active infections, such as sepsis, bacteremia, fungemia, uncontrolled pulmonary infection and active tuberculosis, etc.\n* Positive hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg); positive hepatitis B e antibody (HBe-Ab) or hepatitis B core antibody (HBc-Ab), and the HBV-DNA copy number is above the lower limit of the measurable capacity; positive hepatitis C (HCV) antibody; positive human immunodeficiency virus (HIV) antibody; positive syphilis test.\n* Underwent major surgery within 4 weeks before screening, as determined by the investigator to be unsuitable for enrollment.\n* Have malignant tumors within 5 years before enrollment, except tumors with negligible risk of metastasis or death and curable tumors, such as adequately treated cervical carcinoma in situ, cutaneous basal cell carcinoma, etc.\n* Have any of the following cardiovascular diseases: a.Left ventricular ejection fraction (LVEF) ≤45%, b. presence of active heart disease or congestive heart failure (New York Heart Association \\[NYHA\\] Class III or IV)), c.severe arrhythmias requiring treatment, d.have myocardial infarction, bypass surgery, or stent placement within the 6 months before the study, e.other heart diseases judged by the researcher to be unsuitable for enrollment.\n* Have a history of live attenuated vaccines within 6 weeks before enrollment.\n* Have a history of epilepsy or other active central nervous system diseases.\n* Have an allergy to the ingredients of the medicine used in this study.\n* Previously received CAR-T cell therapy.\n* Patients considered to be ineligible for the study by the investigator for reasons other than the above.","60 Years",{"count":100,"type":20},13,[52],"This is a Phase I, single-arm, open-label, dose-escalation and dose-expansion study. The primary objective is to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of YTS109 STAR-T cell therapy in patients with autoimmune hemolytic anemia who have failed ≥3 lines of therapy.\n\nThis study set up two dosage groups: 1e6 STAR+T cells\u002Fkg and 2e6 STAR+T cells\u002Fkg. With the starting dose of 1e6 STAR+T cells\u002Fkg, it was conducted according to the traditional 3+3 design rule. In this study, if the safety was good but the efficacy was not satisfactory at the dosage level of 2e6 STAR+T cells\u002Fkg, SRC could decide whether to continue increasing the dose to 3e6 STAR+T cells\u002Fkg based on the clinical preclinical data, cumulative safety, tolerance, preliminary efficacy, PK and other results.\n\nIf the subject shows no response (NR) or experiences recurrence after remission, a second infusion may be administered-provided the patient voluntarily consents and the investigator, after comprehensive assessment, determines that the potential benefits outweigh the risks. The investigator may decide on the timing of re-infusion, the use of lymphodepleting pretreatment, and the dose and number of re-infusions based on prior safety, efficacy, and pharmacokinetic (PK) data.",[27],"2026-03-02",{"date":106,"type":32},"2026-03-06",{"date":108,"type":20},"2026-03-18",{"date":110,"type":20},"2028-03-18",{"name":112,"class":39},"China Immunotech (Beijing) Biotechnology Co., Ltd.",{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":120,"targetDuration":4,"studyType":21,"phases":122,"briefSummary":124,"conditions":125,"keywords":128,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":90},"100626891","early-phase-1-ucar-t-targeting-cd19bcma-in-subjects-with-autoantibody-mediated-autoimmune-benign-hematological-diseases-100626891","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.",{"count":121,"type":20},27,[123],"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.",[27,126,127],"Primary Immune Thrombocytopenic Purpura","Evans Syndrome",[129,130,131,132,133],"UCART","CD19\u002FBCMA","ITP","AIHA","EVANS","2026-02-24",{"date":104,"type":32},{"date":137,"type":32},"2026-02-03",{"date":139,"type":20},"2029-06-30",{"name":141,"class":64},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":149,"targetDuration":151,"studyType":76,"phases":4,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":90},"100276392","french-registry-of-adult-patients-with-immune-thrombocytopenia-and-autoimmune-hemolytic-anemia-100276392","NCT02877706","French Registry of Adult Patients With Immune Thrombocytopenia and Autoimmune Hemolytic Anemia","CARMEN","Inclusion Criteria:\n\n* adult patients (18+ year-old)\n* newly diagnosed for ITP\u002FAIHA or initiation of FOSFAMATINIB\n\nExclusion criteria:\n\n\\- opposition to data collection",{"count":150,"type":20},1500,"15 Years","CARMEN is a national, real-world clinical registry of all adult patients with incident diagnosis of Immune thrombocytopenia (ITP) or Autoimmune Hemolytic anemia (AIHA) patients in France. It is aimed at describing ITP and AIHA clinical features, assessing the real-world risk-benefit ratio of treatments and adherence to guidelines for ITP and AIHA management.",[154,27],"Immune Thrombocytopenia",[156],"Registry","2025-12-23",{"date":159,"type":32},"2025-12-31",{"date":161,"type":4},"2013-06",{"date":163,"type":20},"2029-12",{"name":165,"class":64},"University Hospital, Toulouse",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":21,"phases":175,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":90},"100446114","phase-2-efficacy-of-prolonged-anticoagulation-for-primary-prevention-of-venous-thromboembolic-disease-in-autoimmune-hemolytic-anemia-a-prospective-phase-ii-randomized-multicenter-study-100446114","NCT05089227","Efficacy of Prolonged Anticoagulation for Primary Prevention of Venous Thromboembolic Disease in Autoimmune Hemolytic Anemia: a Prospective, Phase II, Randomized, Multicenter Study","API-AHAI","Inclusion Criteria:\n\n* Patient aged ≥ 18 years\n* Patient with a diagnosis of primary or secondary autoimmune hemolytic anemia (AIHA) (infections, hematologic diseases, systemic diseases), according to the following criteria:\n* Hemoglobin \\\u003C12 g\u002FdL\n* and decreased haptoglobin (\\\u003C0.4 g\u002FL)\n* and positive direct antiglobulin test (direct Coombs test) (IgG +\u002F- C3d)\n* Patient newly diagnosed or relapse\n* Patient with an estimated life expectancy of more than 6 months\n* Patient who provided free, written and informed consent\n\nExclusion Criteria:\n\n* Patients with immediate symptomatic VTE, confirmed by appropriate complementary examinations (venous Doppler of the lower limbs, thoracic angioscanner or pulmonary scintigraphy).\n* Patients on curative anticoagulation (venous thromboembolic disease, atrial fibrillation)\n* Patient on dual antiaggregation treatment\n* Patient with active bleeding\n* Patient with a known condition or lesion at risk of bleeding\n* Patient with ischemic stroke with hemorrhagic transformation within 6 months prior to inclusion\n* Patient on preventive anticoagulation for 14 days or more\n* Patient with a contraindication to apixaban:\n* Known hypersensitivity to the molecule or to any of the excipients,,\n* thrombocytopenia \\\u003C100 G\u002FL,\n* kidney failure (glomerular filtration rate \\\u003C 30 ml\u002Fmin\u002F1.73m²)\n* Active liver disease (liver failure defined as Factor V \\\u003C50% or INR \\>1.5, ALT elevation \\>2 times the upper limit of normal)\n* Patients receiving concomitant CYP3A4 inducers (rifampin, phenytoin, carbamazepine, phenobarbital, St. John's Wort) or CYP3A4 inhibitors (azole antifungals, HIV protease inhibitors), if these therapies cannot be discontinued or modified\n* Patients with a contraindication to enoxaparin:\n* allergy to the drug\n* history of heparin-induced thrombocytopenia\n* Patient with cold agglutinin-related AHAI (C3d-positive ADT alone with identification of cold agglutinins)\n* Patient with severe disorders of hemostasis:\n* hypofibrinogenemia \\\u003C 2 g\u002FL,\n* disseminated intravascular coagulation (APTT prolongation\\>1.2, and PT\\\u003C50%, and thrombocytopenia\\\u003C100 G\u002FL, and D-Dimer \\>500 µg\u002FL)\n* hemophilia\n* Patient whose clinical condition requires hospitalization in an intensive care unit\n* Patient who has already participated in the study\n* Patient not affiliated to national health insurance\n* Patient under legal protection (curatorship, guardianship)\n* Patient subject to a measure of legal protection\n* Pregnant, parturient or breastfeeding women\n* Patient with physiological capacity to procreate (having had her first menstrual period and not menopausal and not presenting permanent sterility (hysterectomy, bilateral salpingectomy, bilateral oophorectomy)) and unable to have effective contraception (i.e., provided by an estrogen-progestin oral contraceptive or progestogen, a contraceptive implant, an intrauterine device or a tubal ligation)\n* Patient of legal age who is unable to provide consent",{"count":174,"type":20},72,[23],"Autoimmune hemolytic anemia (AIHA) is a rare autoimmune disease (incidence \\\u003C1\u002F100,000 population) responsible for the destruction of red blood cells by the host immune system, notably through the action of autoantibodies.\n\nApart from complications related to anemia, the occurrence of venous thromboembolism (VTE) in this population is frequent, estimated at 20-27%. The risk of VTE is highest during the period of hemolysis, especially during the first 3 months after the diagnosis of AIHA. This risk is 7.5 \\[4.7; 12.0\\] times greater than in the general population. No clinical predictive factor for VTE was identified and the usual factors (cancer, previous VTE, bed rest \\>3 days, surgery, age \\>70 years, heart or respiratory failure, myocardial infarction, stroke, obesity, hormone replacement therapy) were not considered. Several biological risk factors have been suggested (depth of anemia, bilirubin level, leukocyte count, antiphospholipid antibodies) but have not been confirmed in other studies.\n\nAIHA is therefore a risk factor for VTE in its own right, and the National Diagnostic and Care Protocol (NDCP) recommends the implementation of VTE prevention during acute hemolysis (Grade C). However, the value of this prophylaxis has never been prospectively evaluated and its duration is empirical. In practice, low-molecular-weight heparin (LMWH) is generally used during \"flare-ups\" of AIHA (diagnosis and relapse) in hospitalized patients, but is rarely continued beyond the hospital phase when VTE also occurs in ambulatory patients.\n\nThus, we hypothesize that prolonged preventive anticoagulation during the 12-week risk period following diagnosis or relapse of AIHA could decrease the incidence of VTE.\n\nIn orthopedic surgery, this strategy has been proven to decrease VTE from 50% to 10-15%. In certain high-risk medical situations, prolonged prophylaxis with apixaban has been shown to decrease the occurrence of VTE from 10.2% to 4.2% in solid cancers4 and from 4-11% to 2% in myeloma.",[178,179,27],"Prolonged Anticoagulation","Venous Thromboembolic Disease","2025-12-16",{"date":182,"type":32},"2025-12-22",{"date":184,"type":32},"2022-02-03",{"date":186,"type":20},"2028-08",{"name":188,"class":64},"Centre Hospitalier Universitaire Dijon",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":21,"phases":198,"briefSummary":199,"conditions":200,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":212},"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":197,"type":20},158,[52,23],"To evaluate the efficacy and safety of CM336 (BCMA\u002FCD3 Bispecific Antibody) in the treatment of patients with relapsed or refractory autoimmune cytopenia",[201,202,27,127],"Autoimmune Cytopenia","Immune Thrombocytopenia (ITP)","2025-12-09",{"date":205,"type":32},"2025-12-17",{"date":207,"type":32},"2025-11-18",{"date":209,"type":20},"2028-11-18",{"name":211,"class":39},"Keymed Biosciences Co.Ltd",3,{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":96,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":21,"phases":220,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":4},"100615078","phase-1-a-study-of-yts109-cell-in-subjects-with-relapsedrefractory-autoimmune-hemolytic-anemia-100615078","NCT07287930","A Study of YTS109 Cell in Subjects With Relapsed\u002FRefractory Autoimmune Hemolytic Anemia","Inclusion Criteria:\n\n* Age ≥18 years, regardless of gender.\n* A definitive diagnosis of Autoimmune Hemolytic Anemia (AIHA) or Evans Syndrome \\[including warm antibody-type, mixed warm-cold antibody-type, and cold antibody-type hemolytic anemia (cold agglutinin disease)\\] has been established, with diagnostic criteria referenced from the Chinese Clinical Practice Guidelines for the Diagnosis and Treatment of Autoimmune Hemolytic Anemia in Adults (2023 Edition).\n* Patients who have undergone at least three failed treatment attempts, whose anemia symptoms (hemoglobin \\\u003C 100 g\u002FL) persist despite conventional therapy, and who remain unresponsive or experience recurrence after disease remission. Definition of Conventional Therapy: Treatment with glucocorticoids and\u002For rituximab, combined with any one or more of the following interventions: splenectomy, cyclosporine, cyclophosphamide, azathioprine, mycophenolate mofetil, bendamustine, fludarabine, bortezomib, or other pharmacological agents, as well as biologic agents including anti-CD38 monoclonal antibodies, BTK inhibitors, Syk inhibitors, complement inhibitors, etc.\n* Adequate Organ Function:\n\n  1. Liver Function:\n\n     Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN); Total bilirubin ≤ 2.0 × ULN (excluding Gilbert syndrome, where total bilirubin ≤ 3.0 × ULN).\n  2. Renal Function:\n\n     Creatinine clearance (CrCl) ≥ 60 ml\u002Fminute (calculated using the Cockcroft-Gault formula).\n  3. Oxygen Saturation (SpO₂): ≥ 92%.\n  4. Bone Marrow Function Requirements:\n\n     1. Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL;\n     2. Platelet count ≥ 30 × 10⁹\u002FL;\n     3. International normalized ratio (INR) ≤ 1.5 × ULN;\n     4. Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n* ECOG performance status≤2.\n* Subjects of childbearing potential will be required to follow contraception requirements from the time of enrollment until the end of the 12-month safety follow-up period.\n* The subjects voluntarily participate in the study, sign the informed consent, demonstrate good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n* • Diagnosis of lymphoproliferative tumor\n\n  * Other hereditary or acquired hemolytic diseases (Secondary AIHA caused by drugs or infection)\n  * The platelet count in peripheral blood\\\u003C30×10\\^9\u002FL\n  * Pregnant or breast-feeding subjects\n  * Receive any of the following treatments within the specified time before cell infusion: a.anti-CD20 monoclonal antibodies \\\u003C12 weeks, b.sutimlimab or other marketed biologics \\\u003C5 half-lives,c.plasma exchange \\\u003C4 weeks, d.post-splenectomy \\\u003C12 weeks, e. BTK inhibitors, anti-CD38 monoclonal antibody, Syk inhibitors, BAFF inhibitors \\\u003C 5 half-lives.\n  * Previously received organ or stem cell transplantation\n  * History of new thrombosis or organ infarction in the past 6 months\n  * Diagnosis of the active stage of the connective tissue disease.\n  * Have active infections, such as sepsis, bacteremia, fungemia, uncontrolled pulmonary infection and active tuberculosis, etc.\n  * Positive hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg); positive hepatitis B e antibody (HBe-Ab) or hepatitis B core antibody (HBc-Ab), and the HBV-DNA copy number is above the lower limit of the measurable capacity; positive hepatitis C (HCV) antibody; positive human immunodeficiency virus (HIV) antibody; positive syphilis test.\n  * Underwent major surgery within 4 weeks before screening, as determined by the investigator to be unsuitable for enrollment.\n  * Have malignant tumors within 5 years before enrollment, except tumors with negligible risk of metastasis or death and curable tumors, such as adequately treated cervical carcinoma in situ, cutaneous basal cell carcinoma, etc.\n  * Have any of the following cardiovascular diseases: a.Left ventricular ejection fraction (LVEF) ≤45%, b. presence of active heart disease or congestive heart failure (New York Heart Association \\[NYHA\\] Class III or IV)), c.severe arrhythmias requiring treatment, d.have myocardial infarction, bypass surgery, or stent placement within the 6 months before the study, e.other heart diseases judged by the researcher to be unsuitable for enrollment.\n  * Have a history of live attenuated vaccines within 6 weeks before enrollment.\n  * Have a history of epilepsy or other active central nervous system diseases.\n  * Have an allergy to the ingredients of the medicine used in this study.\n  * Previously received CAR-T cell therapy.\n  * Patients considered to be ineligible for the study by the investigator for reasons other than the above.",{"count":100,"type":20},[52],"This is a Phase I, single-arm, open-label, dose-escalation and dose-expansion study. The primary objective is to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of YTS109 STAR-T cell therapy in patients with autoimmune hemolytic anemia who have failed ≥3 lines of therapy. The objective is to evaluate the safety, preliminary efficacy, pharmacokinetics\u002Fpharmacodynamics (PK\u002FPD), and immune cell reconstitution characteristics of YTS109 cell therapy in Multi-rAIHA subjects who have failed third-line or higher-line treatments.\n\nThis study will also conduct an exploratory investigation into the impact of non-lymphodepleting conditioning prior to the infusion of STAR-T cells. For the non-lymphodepleting exploratory cell infusion, it can be administered as a single infusion or divided into 1 to 3 infusions (with the fractionated infusions to be completed within 7 days (and in any case no later than 15 days)). Dose escalation will commence at 1E6 cells\u002Fkg or the starting dose may be adjusted based on accumulated data.",[27],"2025-12-04",{"date":205,"type":32},{"date":226,"type":20},"2025-12-25",{"date":228,"type":20},"2027-12-26",{"name":141,"class":64},{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":236,"targetDuration":4,"studyType":21,"phases":237,"briefSummary":238,"conditions":239,"keywords":240,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":90},"100607569","phase-2-a-single-arm-phase-2-prospective-clinical-study-of-enatumab-in-the-treatment-of-relapsedrefractory-warm-antibody-autoimmune-hemolytic-anemia-100607569","NCT07190261","A Single-arm Phase 2 Prospective Clinical Study of Enatumab in the Treatment of Relapsed\u002FRefractory Warm Antibody Autoimmune Hemolytic Anemia","Inclusion Criteria:\n\n1. Age ≥18 years old, gender not limited.\n2. Primary wAIHA with a clear diagnosis.\n3. Patients who have relapsed or are refractory after at least second-line treatment (previous treatments include at least two types of glucocorticoids, CD20 monoclonal antibodies or other immunosuppressants). Refractory is defined as failure to achieve partial remission after 6 months of treatment with a stable dose of immunosuppressants.\n4. The infusion of CD20 monoclonal antibody should be at least three months apart. If taking immunosuppressants such as cyclosporine and sirolimus, the medication should be discontinued for at least one month.\n5. Hemoglobin (HGB) ≤100g\u002F and ≥ 60g\u002FL.\n6. Before treatment, the patient's alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were less than 3 times the upper limit of normal (ULN), and the serum creatinine was less than 1.5 times ULN.\n7. Voluntarily join this study, sign the informed consent form with good compliance, and be willing to cooperate with regular follow-ups for efficacy evaluation and side effect monitoring.\n\nExclusion Criteria:\n\n* (1) Those with impaired functions of organs such as the heart, liver and lungs; Patients with acute renal insufficiency.\n\n  (2) Patients with connective tissue diseases and other secondary AIHA. (3) There is an active infection of hepatitis B virus (HBV), hepatitis C virus (HCV), severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), human immunodeficiency virus (HIV), or any uncontrolled bacterial, fungal or viral infection.\n\n  (4) Complicated with malignant tumors or a history of tumors. (5) When screening, the subjects had other types of uncorrected anemia, such as nutritional anemia, etc.\n\n  (6) Had received other BCMA-targeted or CART treatments before screening. (7) Pregnant or lactating women. (8) Activity ≥ grade 2 peripheral sensory\u002Fmotor neuropathy. (9) Had received treatment with other experimental drugs within 30 days (or as required by local regulations) or within 5 half-lives (whichever is longer) prior to the first use of the intervention drug in this study.",{"count":212,"type":20},[23],"Glucocorticoids are the first-line treatment for wAIHA, but patients are prone to recurrence after dose reduction or discontinuation of glucocorticoids. Birgens et al. 's study found that approximately 55% of patients treated with prednisolone monotherapy experienced recurrence at 36 months. The overall response rate of second-line treatment with rituximab is 70-80%, but the recurrence rate reaches 50%. The response rates of other immunosuppressants, such as cyclosporine, cyclophosphamide, and azathioprine, are relatively low, approximately 30-50%. Patients with chronic hemolysis have recurrent episodes, which affect their survival and quality of life. New treatment methods need to be explored.",[27],[27,241,242],"Enatumab","Single-arm phase 2 prospective","2025-09-23",{"date":245,"type":32},"2025-09-24",{"date":247,"type":20},"2025-09-18",{"date":249,"type":20},"2027-09-18",{"name":251,"class":64},"Bing Han",{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":21,"phases":260,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":90},"100584409","early-phase-1-safety-study-of-cc312-in-autoimmune-disease-patients-100584409","NCT06888960","Safety Study of CC312 in Autoimmune Disease Patients","An Exploratory Clinical Study on the Safety of CC312 in Treating Patients With Refractory Autoimmune Diseases","Inclusion Criteria:\n\n* Subjects who fully understand the objectives, nature, methods of the study, and possible adverse reactions, voluntarily participate as subjects, and sign the informed consent form (ICF).\n* Age ≥18 years (inclusive, based on the time of signing ICF), male or female.\n* For SLE:\n\n  1. Subjects who are diagnosed with SLE according to the 2019 European League Against Rheumatism (EULAR)\u002F1997 American College of Rheumatology (ACR) diagnostic classification criteria;\n  2. SLEDAI-2000 score of ≥ 8 points and at least one BILAG grade A or two BILAG grade B under standard treatment conditions;\n  3. Meet one of the following conditions: antinuclear antibody (ANA) determined to be positive during the screening period, or anti-dsDNA antibodies higher than normal levels at screening, or anti-Sm antibodies higher than normal levels at screening;\n  4. Before the first dose of the investigational drug, subjects must have received at least one of the following standard treatments for 12 weeks, and the dose must have been stable for at least 30 days (dose reduction is allowed and dose increase is not allowed ). Standard treatment regimen refers to the stable use of any of the following (alone or in combination): a. Antimalarial (hydroxychloroquine) monotherapy; b. Antimalarials in combination with oral corticosteroids (OCS, e.g., prednisone or other hormones at equivalent doses) and\u002For immunosuppressants (including mycophenolate mofetil, cyclophosphamide, leflunomide, methotrexate, tacrolimus, ciclosporin, azathioprine, Tripterygium wilfordii); c. OCS and\u002For immunosuppressant combination therapy. If the subject is receiving OCS (e.g., prednisone or other hormones at equivalent doses), the following criteria must be met: at screening and during the screening period, the maximum dose of OCS is 30 mg\u002Fday of prednisone (or other hormones at equivalent doses); other drugs and traditional Chinese medicines that affect immunity may be continued at the discretion of the investigator.\n* For IIM:\n\n  1. According to the 2017 EULAR\u002FACR Classification Criteria, diagnosed as possible or definite IIM-possible IIM: with a score of 5.5 points without biopsy; definite IIM: with a score of 6.7 points with biopsy;\n  2. Meeting one of the following criteria: During or before the screening period, confirmed to have at least one positive myositis-specific autoantibody (MSA), myositis-associated autoantibody (MAA), or ANA;\n  3. Conventional treatment is ineffective or the disease relapses after remission. Conventional treatment is defined as: the use of glucocorticoids (prednisone \\>1 mg\u002Fkg\u002Fd or equivalent dose) and\u002For at least one immunomodulatory drug: such as antimalarial drugs, azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, tacrolimus, ciclosporin, and\u002For biological drug products: such as rituximab and belimumab.\n* For IIM:\n\n  1. Subjects who are diagnosed with SSc according to the 2013 EULAR\u002FACR diagnostic classification criteria;\n  2. Meets one of the following criteria: positive ANA confirmed during or before the screening period, or at least one positive SSc-related antibody profile (such as Scl70, Th\u002FTo, RP11\u002F12, U3RNP autoantibodies);\n  3. Conventional treatment is ineffective or the disease relapses after remission. Conventional treatment is defined as: using glucocorticoids (prednisone \\> 0.5 mg\u002Fkg\u002Fd or equivalent dose) and cyclophosphamide, and any of the following immunomodulatory drugs: such as antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, ciclosporin, and\u002For biological agents: such as rituximab and belimumab, with a cumulative treatment duration \\> 6 months.\n* For RA:\n\n  1. Diagnosed with RA according to the 2010 EULAR\u002FACR diagnostic classification criteria;\n  2. Disease Activity Score DAS28-ESR \\>3.2 (i.e., moderate activity or higher) during the screening period;\n  3. Failure after treatment with at least one conventional disease-modifying antirheumatic drug (DMARD) and\u002For at least one targeted synthetic DMARD (tsDMARD)\u002Fbiologic DMARD (bDMARD) (defined as no remission after at least 3 months of treatment);\n  4. At screening, if the subject is taking prednisone or an equivalent dose of a glucocorticoid, the dose must be ≤10 mg\u002Fday and stable for at least 4 weeks before the first dose;\n  5. The subject must have discontinued traditional Chinese medicine for the treatment of RA for ≥4 weeks before the first dose;\n  6. Other DMARDs, except for methotrexate (MTX) (subjects who have been on routine MTX treatment for 12 weeks before enrollment, with a stable MTX dose for 4 weeks before enrollment), must meet the washout period requirements: discontinuation of conventional synthetic DMARDs (csDMARDs) (including but not limited to sulfasalazine, leflunomide, penicillamine, azathioprine, ciclosporin A, cyclophosphamide, hydroxychloroquine, etc.) and herbal agents (including Tripterygium wilfordii, total glucosides of paeony, sinomenine, etc.) for 4 weeks before the first dose; discontinuation of intra-articular, intramuscular, or intravenous corticosteroids for 4 weeks before the first dose; discontinuation of anakinra and etanercept for 4 weeks before the first dose; discontinuation of adalimumab and infliximab for 8 weeks before the first dose; discontinuation of golimumab, certolizumab pegol, and tocilizumab for 10 weeks before the first dose; discontinuation of abatacept for 12 weeks before the first dose; in addition, stable doses of nonsteroidal anti-inflammatory drugs (NSAIDs) are permitted to be continued.\n* For ITP:\n\n  1. Diagnosed with ITP according to the diagnostic criteria of the Chinese Guideline on the Diagnosis and Management of Adult Primary Immune Thrombocytopenia (2020 Edition);\n  2. Ineffective response or relapse after at least one prior treatment regimen (including but not limited to TPO mimetics\u002Fagonists, corticosteroids, immunoglobulins, azathioprine, cyclophosphamide, and\u002For rituximab);\n  3. At least 2 platelet count measurements (with an interval of more than 24 hours) from the screening period to before the first dose, with an average platelet count \\\u003C30×109\u002FLand no single platelet count\\>35×109\u002FL;\n  4. If receiving standard background therapy for ITP, the dose and frequency of this therapy should be stable for at least 4 weeks (dose change ≤10%) before the first dose.\n* For AIHA:\n\n  1. Diagnosed with AIHA according to the diagnostic criteria of the Chinese Guideline on the Diagnosis and Management of Autoimmune Haemolytic Anaemia (2022 Edition);\n  2. Poor response after at least first-line treatment (corticosteroids);\n  3. Presence of anaemia-related symptoms during the screening period;\n  4. The dose of supportive care must be stable for at least 4 weeks before the first dose.\n* Laboratory test results:\n\nComplete blood count:\n\n1. SLE, SSc, and IIM: Absolute neutrophil count ≥1.0 x109\u002FL, haemoglobin ≥60 g\u002FL, platelets ≥50 x109\u002FL;\n2. RA: Neutrophil count ≥1.5 x109\u002FL, haemoglobin ≥90 g\u002FL, platelets ≥100 x109\u002FL;\n3. ITP: Absolute neutrophil count ≥1.0 x109\u002FL, haemoglobin ≥70 g\u002FL, platelets ≥10 x109\u002FL;\n4. AIHA: Absolute neutrophil count ≥1.0 x109\u002FL, platelets ≥50 x109\u002FL (≥10 x109\u002FL for patients with Evans syndrome and transfusion is permitted).\n\nLiver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C3 times the upper limit of normal (ULN), and total serum bilirubin ≤1.5×ULN (≤3.0×ULN for Gilbert's syndrome) or if bilirubin abnormality is caused by the study disease, participation is allowed upon investigator's judgment.\n\nRenal function: For RA, ITP, and AIHA: Serum creatinine ≤1.5 times ULN, or calculated creatinine clearance \\>50 mL\u002Fmin (Cockcroft-Gault formula).\n\n* Left ventricular ejection fraction (LVEF) ≥50%.\n* Female subjects of childbearing potential must agree to use effective contraception from the screening period until 6 months after the last dose. Additionally, they must agree to refrain from collecting or donating eggs during this period; any male partners of reproductive potential must also agree to use effective contraceptive measures during this period.\n* Male subjects with reproductive potential must agree to use effective contraception from the screening period to 6 months after the last dose, and have no plans for reproduction or sperm donation. During this period, their female partners of childbearing potential must also agree to use effective contraception.\n\nExclusion Criteria:\n\n* Subjects who have severe lupus nephritis (defined as urinary protein \\>6 g\u002F24 h or serum creatinine \\>2.5 mg\u002FdL or 221 μmol\u002FL), or required treatment of active nephritis with protocol-prohibited drugs, or required hemodialysis or received prednisone ≥100 mg\u002Fd or equivalent glucocorticoid therapy for ≥14 days within 8 weeks before screening.\n* Subjects who have central nervous system diseases caused by SLE or not caused by SLE within 8 weeks before screening (including but not limited to epilepsy, psychosis, posterior reversible encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis, etc.).\n* Other types of IIM: inclusion body myositis, diabetic amyotrophy, juvenile myositis; severe muscle injury or myositis causing permanent weakness or cardiac involvement due to non-IIM causes (e.g., stroke).\n* Pulmonary arterial hypertension associated with SSc requiring treatment; or rapidly progressive SSc-related lower gastrointestinal tract (small and large intestine) involvement (requiring parenteral nutrition), active antral vascular ectasia; previous renal crisis caused by SSc.\n* Significant organ transplantation (e.g., heart, lung, kidney, liver) or history of hematopoietic stem cell\u002Fbone marrow transplantation.\n* Concomitant presence of two or more immune diseases requiring systemic treatment, if the investigator deems the subject unsuitable for enrollment.\n* IgA deficiency (serum IgA level \\\u003C10 mg\u002FdL).\n* Have participated in any other clinical trials (including cell or gene therapy) within 4 weeks before screening or within 5 half-lives of the investigational product (whichever is longer).\n* Have received CAR-T therapy within 6 months before screening.\n* Have received B-cell depleting drug rituximab or equivalent treatments (targeting CD19, CD20, BAFF, etc.) within 1 month before screening, unless it can be demonstrated that B cells have returned to pre-treatment levels or within the normal range.\n* Have received anti-SLE treatments (e.g., Saphnelo) other than standard therapy within 3 months before screening or within 5 half-lives of the investigational product (whichever is longer).\n* Have received a live\u002Fattenuated vaccine within 4 weeks before screening or plans to receive a live\u002Fattenuated vaccine during the study.\n* Active infection.\n* History of Grade 3-4 (CTCAE v5.0) allergic reaction to another monoclonal antibody treatment, or known allergy to any component or excipient of the CC312 drug product (including recombinant proteins, polysorbate 80, etc.); patients with a ≤Grade 3 allergy lasting \\\u003C24h may participate in this study after discussion with the investigator.\n* Acknowledgement of or evidence of illicit drug use, drug abuse, or alcoholism.\n* Subjects who have received major surgery within 4 weeks before screening or minor surgery within 2 weeks; wounds must be completely healed (surgical procedures such as catheter placement are not exclusion criteria).\n* History of any of the following cardiovascular diseases within 6 months before screening: NYHA Class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia, or other clinically significant heart disease.\n* Any other serious underlying diseases (e.g., active gastric ulcer, uncontrolled seizures, cerebrovascular events, gastrointestinal bleeding, severe signs and symptoms of coagulation dysfunction, heart diseases), mental illnesses, psychological, familial, or endemic diseases that, in the investigator's judgment, may interfere with the planned staging, treatment, and follow-up; affect subjects; compliance; or expose the subjects to a higher risk of complications.\n* Evidence of concurrent malignant tumors within less than 5 years before screening, excluding adequately treated cervical carcinoma in situ, localized cutaneous squamous cell carcinoma, basal cell carcinoma, localized prostate cancer, ductal carcinoma in situ of the breast, or urothelial carcinoma of stage ≤T1. Subjects with prostate cancer undergoing active surveillance are eligible for this study.\n* Pregnant or breastfeeding women.\n* Subjects with positive results for viral serological tests during the screening period: positive for human immunodeficiency virus antibody (HIV-Ab), hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), or Treponema pallidum antibody (TP-Ab).\n* Subjects with active or latent tuberculosis (positive T-SPOT) identified during the screening period.\n* History of splenectomy treatment within 6 months prior to screening.\n* ITP subjects: 1) Secondary immune thrombocytopenia secondary to SLE, chronic lymphocytic leukemia (CLL), immunodeficiency common variable (CVID), or antiphospholipid syndrome (APS); 2) Drug-induced thrombocytopenia; 3) Any bleeding event requiring treatment within 4 weeks prior to screening; 4) Within 2 weeks prior to screening, the subject has continuously used drug therapy that affects platelet function (including but not limited to aspirin, aspirin-containing compounds, clopidogrel, salicylates, and\u002For NSAIDs) for \\>3 days; 5) History of any arterial or venous thrombosis (stroke, transient ischaemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism), or clinical symptoms and medical history suggestive of thrombophilia; or any of the following: known arrhythmia that increases the risk of thrombotic events (e.g., atrial fibrillation), or corrected QT interval (QTc) \\>450 msec; or a history of other coagulation abnormalities.\n* ITP and AIHA subjects: Abnormal prothrombin time (PT), international normalized ratio (INR), and activated partial thromboplastin time (aPTT) that are considered clinically significant by the investigator.\n* Other subjects whom the investigator judges to be unsuitable for this study.",{"count":50,"type":20},[123],"This study is an open-label, multiple-dose escalation, Investigator-Initiated Trial (IIT) clinical trial designed to evaluate the safety and tolerability of CC312 in adult patients with relapsed and refractory autoimmune diseases. The trial also assesses pharmacokinetics (PK) and preliminary efficacy.\n\nCC312 is a trispecific T cell engager (TriTE) that targets the B cell surface antigen CD19, the T cell antigen CD3, and the T cell co-stimulatory molecule CD28. Given its mechanism of action, which is similar to the \"biopharmaceutical version\" of CAR-T, there is a higher risk of cytokine release syndrome (CRS) at the onset of infusion administration. Therefore, a lower priming dose will be administered before the therapeutic dosing phase to mitigate this risk and ensure safety, followed by a therapeutic dose to achieve and maintain efficacy.\n\nThe study is divided into three dose groups, with 3-6 subjects enrolled in each group, resulting in a total of 9-18 subjects in the study. A \"3+3\" dose escalation design is employed to systematically evaluate the safety and determine the optimal dose of CC312.",[263,264,265,266,267,27],"Systemic Lupus Erythematosus (SLE)","Idiopathic Inflammatory Myopathy (IIM)","Systemic Sclerosis (SSc)","Rheumatoid Arthritis (RA)","Primary Immune Thrombocytopenia (ITP)","2025-09-11",{"date":270,"type":32},"2025-09-17",{"date":272,"type":32},"2024-11-08",{"date":274,"type":20},"2026-11-08",{"name":276,"class":39},"CytoCares Inc",{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":283,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":285,"conditions":286,"keywords":287,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":4},"100604461","a-single-arm-phase-2-prospective-clinical-study-of-linprixel-in-the-treatment-of-relapsedrefractory-autoimmune-hemolytic-anemia-100604461","NCT07149818","A Single-arm Phase 2 Prospective Clinical Study of Linprixel in the Treatment of Relapsed\u002FRefractory Autoimmune Hemolytic Anemia","Inclusion Criteria:\n\n（1）Age ≥18 years old (2) Clearly diagnosed wAIHA or EVANS syndrome, cAIHA, primary or secondary connective tissue diseases. If it is secondary, there are no indications for the treatment of connective tissue diseases involving other systems.\n\n(3) Patients who relapse or are refractory after at least two lines of treatment (previous treatments include glucocorticoids, CD20 monoclonal antibodies or at least two other immunosuppressants). Refractory is defined as the failure to achieve partial remission after 3 months of stable dose treatment with immunosuppressants.\n\n(4) hb≤100 g \u002F L (5) Those with complete clinical data, high treatment compliance, and those who have signed the informed consent form; (6) If glucocorticoids are being taken, they should be discontinued or the minimum maintenance dose has been taken for at least two weeks, and the minimum maintenance dose (≤15mg\u002Fday) should be continued subsequently (7) The infusion of CD20 monoclonal antibody should be at least 3 months or more. If the stable dose of immunosuppressants such as cyclosporine and sirolimus has been taken for at least 3 months, they should be discontinued upon enrollment.\n\nExclusion Criteria:\n\n1. Those with incomplete functions of organs such as the heart, liver and lungs; Patients with acute renal insufficiency\n2. Combined with connective tissue diseases, other vital organs are involved.\n3. Uncontrolled infection or bleeding after standard treatment. Standard treatment for uncontrolled active infections of HIV, HCV or HBV.\n4. Combined with advanced uncontrolled malignant tumors and lymphomas.\n5. At the time of screening, the subjects had other types of uncorrected anemia, such as nutritional anemia, etc\n6. Pregnant or lactating women.\n7. Those who have used PI3Kδ inhibitors within the past 6 months;\n8. Those who have participated in other clinical trials within three months.",{"count":284,"type":20},22,"wAIHA or EVANS syndrome: Linpriril 40mg, oral, once daily. The therapeutic effect will be evaluated after 4 weeks. If the therapeutic effect does not reach the PR, the dose will be increased to 60mg once a day. After continuing to take it for 4 weeks, the therapeutic effect will be evaluated again. If the PR is not reached, it can be increased to 80mg. If the PR is still not reached after continuing to take it for 4 weeks, it will be discontinued (for a total of 12 weeks). The initial dose is 40mg, taken orally once a day. If the therapeutic effect reaches PR or above after 4 weeks, continue taking this dose. The evaluation is the same as before every 4 weeks. The research period was 12 weeks. The duration of continuous treatment for effective patients is determined by the researchers, and the dosage of the drug can be reduced or increased.\n\ncAIHA: Linpriril 80mg, oral administration, once daily. The therapeutic effect was evaluated every 4 weeks. The research period was 12 weeks. The treatment was discontinued if the therapeutic effect did not reach the PR within 12 weeks. The duration of continuous treatment for effective patients is determined by the researchers, and the dosage of the drug can be reduced or increased.",[27],[27],"2025-08-29",{"date":290,"type":32},"2025-09-02",{"date":292,"type":20},"2025-09-01",{"date":294,"type":20},"2027-01-01",{"name":296,"class":64},"Peking Union Medical College Hospital",{"id":298,"slug":299,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":73,"enrollmentInfo":304,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":306,"conditions":307,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":90},"100586945","brain-function-and-psychological-changes-related-to-cell-therapy-for-autoimmune-hemolytic-anemia-100586945","NCT06921980","Brain Function and Psychological Changes Related to Cell Therapy for Autoimmune Hemolytic Anemia","Brain Function and Psychological Assessment in Patients With Autoimmune Hemolytic Anemia Undergoing Cell Therapy","Inclusion Criteria:\n\n* Diagnosis of AIHA\n* Subjects will receive cell therapy such as CAR T-cell therapy\n* Male or female, aged 18-65 years\n* Willing and able to comply with the requirements for this study and written informed consent\n\nExclusion Criteria:\n\n* History of psychiatric illness\n* History of severe brain disease\n* Subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study",{"count":305,"type":20},20,"Cell therapy is an innovative treatment with significant efficacy in hematologic and certain autoimmune diseases. Although it offers potential benefits for autoimmune hemolytic anemia (AIHA), it may result in cognitive and other potential impairments, which can adversely affect patients' cognition and behavior.\n\nBrain function and psychological assessment are essential for the early detection of potential impairments, allowing timely interventions to prevent complications and ensure patient safety. This study aims to comprehensively evaluate the physical and psychological impacts of cell therapy on AIHA patients to develop safer and more effective treatment strategies that enhance their quality of life.",[308,27,309,310],"CAR T-cell Therapy","Brain Function","Psychological Well-Being","2025-07-31",{"date":313,"type":32},"2025-08-05",{"date":315,"type":32},"2025-02-25",{"date":317,"type":20},"2026-12-31",{"name":63,"class":64},{"id":320,"slug":321,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":21,"phases":327,"briefSummary":328,"conditions":329,"keywords":336,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":90},"100591308","phase-1-ucar-t-cell-therapy-targeting-cd19-bcma-in-patients-with-relapse-refractory-autoimmune-diseases-100591308","NCT06978738","UCAR T-cell Therapy Targeting CD19\u002F BCMA in Patients With Relapse\u002F Refractory Autoimmune Diseases","A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\n* 1.Age ≥ 18 years old (inclusive), regardless of gender.\n* 2.Positive expression of CD19 on peripheral blood B cells confirmed by flow cytometry.\n* 3.Functional requirements for major organs are as follows:\n\n  1. Bone marrow function must meet: A. Neutrophil count ≥ 0.5×10 \\^ 9\u002FL (no colony-stimulating factor treatment within 2 weeks before examination); B. Hemoglobin ≥ 60g\u002FL; C. Platelets ≥ 30 × 10 \\^ 9\u002FL.\n  2. Liver function: Alanine aminotransferase (ALT) ≤ 3×ULN (excluding ALT elevation due to inflammatory myopathy), aspartate aminotransferase (AST)≤3×Upper limit of normal (ULN) (excluding AST elevation due to inflammatory myopathy), TBIL≤1.5×ULN (or ≤ 3.0×ULN for subjects with Gilbert syndrome);\n  3. Renal function: creatinine clearance rate (CrCl) ≥ 30ml\u002Fminute (calculated by Cockcroft\u002FGault formula, acute CrCl decrease due to the target disease is excluded; LN is exluded);\n* 4.ECOG score 0-1.\n* 5.Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative Human chorionic gonadotropin (HCG) test within 7 days before study enrollment and not be lactating.\n* 6.Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.\n* 7.Subjects with relapsed or refractory autoimmune diseases, Including relapsed or refractory Autoimmune Hemolytic Anemia, relapsed or refractory Systemic Lupus Erythematosus, relapsed or refractory or Progressive Systemic Sclerosis, relapsed or refractory or Progressive Inflammatory Myopathy, relapsed or refractory ANCA-Associated Vasculitis, relapsed or refractory Immunoglobulin-G4 related disease and relapsed or refractory Myasthenia Gravis.\n\nExclusion Criteria:\n\n* 1.Subjects with a history of severe drug allergies or allergic constitutions;\n* 2\\. Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections;\n* 3\\. Subjects with insufficient cardiac function;\n* 4\\. Subjects with congenital immunoglobulin deficiencies;\n* 5\\. Subjects with a history of malignant tumors within the past five years, except for the following conditions: non-melanoma skin cancer, stage I tumors with a low recurrence probability after complete resection, clinically localized prostate cancer after treatment, cervical carcinoma in situ confirmed by biopsy or squamous intraepithelial lesion shown by smear, and stable papillary thyroid carcinoma or follicular thyroid carcinoma.\n* 6\\. Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA \\>ULN; subjects positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; individuals positive for human immunodeficiency virus (HIV) antibody; individuals positive for syphilis testing;\n* 7\\. Subjects with mental illness and severe cognitive dysfunction;\n* 8\\. Pregnant women or women planning to conceive;\n* 9.Subjects whom the investigator believes have other reasons that make them unsuitable for inclusion in this study.",{"count":50,"type":20},[52],"This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19\u002FBCMA CAR T-cells in With Relapse\u002FRefractory Autoimmune Diseases.",[330,27,331,332,333,334,335],"Systemic Lupus Erythematosus","Myasthenia Gravis","Systemic Sclerosis","ANCA-Associated Vasculitis","Inflammatory Myopathy","IgG4-RD",[337,338],"Universal Allogeneic CAR T-cells","CD19\u002FBCMA CAR T-cells","2025-05-11",{"date":341,"type":32},"2025-05-18",{"date":343,"type":20},"2025-05",{"date":345,"type":20},"2028-11",{"name":347,"class":64},"Changzhou No.2 People's Hospital",{"id":349,"slug":350,"hasResults":11,"nctId":351,"briefTitle":352,"officialTitle":352,"acronym":353,"eligibilityCriteria":354,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":355,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":357,"conditions":358,"keywords":360,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":90},"100362933","biological-bank-for-the-patients-followed-in-a-constitutive-reference-center-for-autoimmune-cytopenia-100362933","NCT04005638","Biological Bank for the Patients Followed in a Constitutive Reference Center for Autoimmune Cytopenia","BIOCAI","Inclusion Criteria:\n\n* Patients over 16 years old.\n* Patients with autoimmune cytopenia according to the definitions reported in the latest update of the French National Care Protocol (PNDS 2017).\n* Affiliated person or beneficiary of a social security scheme.\n* Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).\n\nExclusion Criteria:\n\n* Positivity for HIV, Hepatitis C or B virus.\n* Pregnant or lactating woman.\n* Patient undergoing treatment for autoimmune cytopenia",{"count":356,"type":20},200,"The Internal Medicine Department of Haut-Lévêque Hospital (Pr E LAZARO, Pr JL PELLEGRIN, Pr JF VIALLARD) was accredited in 2017 by the Ministry of Health as a Constitutive Reference Center for Autoimmune Cytopenia. The investigators wish to launch new research projects in autoimmune cytopenia and propose a translational and fundamental research based on collaboration between the clinical department, the biological resource center and the CNRS and INSERM research units (\"Bedside to the Bench Strategy\"). Thus, in the perspective of future research work, it seems imperative to set up a biological bank for the patients followed in our Reference Center.",[154,27,359],"Autoimmune Neutropenia",[361],"Biological collection","2025-03-25",{"date":364,"type":32},"2025-03-26",{"date":366,"type":32},"2019-02-02",{"date":368,"type":20},"2027-01",{"name":370,"class":64},"University Hospital, Bordeaux",{"id":372,"slug":373,"hasResults":11,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":4,"eligibilityCriteria":377,"healthyVolunteers":11,"sex":16,"minAge":378,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":21,"phases":381,"briefSummary":382,"conditions":383,"keywords":386,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":4},"100575301","phase-1-a-study-of-yts109-cell-injection-in-subjects-with-relapsedrefractory-autoimmune-hemolytic-anemia-100575301","NCT06770504","A Study of YTS109 Cell Injection in Subjects With Relapsed\u002FRefractory Autoimmune Hemolytic Anemia","The Safety and Efficacy of YTS109 Cell Injection for Relapsed\u002FRefractory Autoimmune Hemolytic Anemia Patients After Receiving Three or More Lines of Therapy.","Inclusion Criteria:\n\n* Age ≥12 years, regardless of gender.\n* Diagnosis of AIHA or Evans syndrome \\[including warm antibody, mixed AIHA and cold antibody AIHA (Cold agglutinin disease)\\].\n* Failure or intolerance to at least 3 lines of therapy: glucocorticoids and\u002For rituximab, and any one of the following treatments (splenectomy, cyclosporine, cyclophosphamide, azathioprine, mycophenolate mofetil, bendamustine, fludarabine, bortezomib, etc.Biologics, including anti-CD38 monoclonal antibody, BTK inhibitor, Syk inhibitor and complement inhibitor) (HGB \\\u003C 100g\u002FL).\n* Adequate organ function: a. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN. b. Creatinine clearance (CrCl) (Cockcroft-Gault formula) ≥60ml\u002Fmin. c.Blood oxygen saturation (SpO2) ≥92%.\n* ECOG performance status≤2\n* Subjects of childbearing potential will be required to follow contraception requirements from the time of enrollment until the end of the 12-month safety follow-up period.\n* The subjects voluntarily participate in the study, sign the informed consent, demonstrate good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n* Diagnosis of lymphoproliferative tumor\n* Other hereditary or acquired hemolytic diseases (Secondary AIHA caused by drugs or infection)\n* The platelet count in peripheral blood\\\u003C30×10\\^9\u002FL\n* Pregnant or breast-feeding subjects\n* Receive any of the following treatments within the specified time before cell infusion: a.anti-CD20 monoclonal antibodies \\\u003C12 weeks, b.sutimlimab or other marketed biologics \\\u003C5 half-lives,c.plasma exchange \\\u003C4 weeks, d.post-splenectomy \\\u003C12 weeks, e. BTK inhibitors, anti-CD38 monoclonal antibody, Syk inhibitors, BAFF inhibitors \\\u003C 5 half-lives.\n* Previously received organ or stem cell transplantation\n* History of new thrombosis or organ infarction in the past 6 months\n* Diagnosis of the active stage of the connective tissue disease.\n* Have active infections, such as sepsis, bacteremia, fungemia, uncontrolled pulmonary infection and active tuberculosis, etc.\n* Positive hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg); positive hepatitis B e antibody (HBe-Ab) or hepatitis B core antibody (HBc-Ab), and the HBV-DNA copy number is above the lower limit of the measurable capacity; positive hepatitis C (HCV) antibody; positive human immunodeficiency virus (HIV) antibody; positive syphilis test.\n* Underwent major surgery within 4 weeks before screening, as determined by the investigator to be unsuitable for enrollment.\n* Have malignant tumors within 5 years before enrollment, except tumors with negligible risk of metastasis or death and curable tumors, such as adequately treated cervical carcinoma in situ, cutaneous basal cell carcinoma, etc.\n* Have any of the following cardiovascular diseases: a.Left ventricular ejection fraction (LVEF) ≤45%, b. presence of active heart disease or congestive heart failure (New York Heart Association \\[NYHA\\] Class III or IV)), c.severe arrhythmias requiring treatment, d.have myocardial infarction, bypass surgery, or stent placement within the 6 months before the study, e.other heart diseases judged by the researcher to be unsuitable for enrollment.\n* Have a history of live attenuated vaccines within 6 weeks before enrollment.\n* Have a history of epilepsy or other active central nervous system diseases.\n* Have an allergy to the ingredients of the medicine used in this study.\n* Previously received CAR-T cell therapy.\n* Patients considered to be ineligible for the study by the investigator for reasons other than the above.","12 Years",{"count":380,"type":20},7,[52],"This is a Phase I, single-arm, open-label, dose-escalation and dose-expansion study. The primary objective is to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of YTS109 START T-cell therapy in patients with autoimmune hemolytic anemia who have failed ≥3 lines of therapy.",[27,384,385],"Anti-CD19 STAR T-cell Therapy","Failure ≥3 Lines of Therapies",[387,388],"Relapsed\u002FRefractory Autoimmune Hemolytic Anemia","CD19-STAR T cells","2025-01-07",{"date":391,"type":32},"2025-01-13",{"date":393,"type":20},"2025-01-16",{"date":395,"type":20},"2026-12-30",{"name":63,"class":64},{"id":398,"slug":399,"hasResults":11,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":4,"eligibilityCriteria":403,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":404,"targetDuration":4,"studyType":21,"phases":406,"briefSummary":407,"conditions":408,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":90},"100572464","phase-1-car-t-cell-therapy-targeting-cd19-and-bcma-in-patients-with-aiha-who-have-failed-3-lines-of-therapy-100572464","NCT06733610","CAR T-cell Therapy Targeting CD19 and BCMA in Patients with AIHA Who Have Failed ≥3 Lines of Therapy.","A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients with Autoimmune Hemolytic Anemia Have Failed ≥ 3 Lines of Therapy","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Flow cytometry detected positive B cell CD19 or BCMA in the patient's peripheral blood.\n* Patients diagnosed with AIHA, including warm antibody type, cold agglutinin disease, mixed type, and other types of AIHA, with diagnostic criteria referring to the \"Chinese Adult Autoimmune Hemolytic Anemia Diagnosis and Treatment Guidelines (2023 Edition)\"\n* The definition of recurrent\u002Frefractory AIHA that has received at least 3 failed lines of treatment is symptomatic anemia (hemoglobin\\\u003C100g\u002FL) that persists after a routine treatment cycle of at least 6 months and is still ineffective or reappears after disease remission. The definition of conventional treatment: treatment with glucocorticoids and\u002For rituximab, as well as any 1-2 or more of the following immunomodulatory drugs: cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine A, azathioprine, danazol, bendamustine, fludarabine, bortezomib, and biologics including daratumumab, BTK inhibitors, Syk inhibitors, and complement inhibitors.\n* ECOG ≤ 2\n* Functional requirements for major organs are as follows:\n\n  1. . The bone marrow function needs to meet: a Neutrophil count ≥ 1.0 × 10 \\^ 9\u002FL; b. Platelets ≥ 30 × 10 \\^ 9\u002FL.\n  2. Liver function: ALT ≤ 3 × UL; AST ≤ 3×ULN； Total bilirubin ≤ 2.0 × ULN (excluding Gilbert syndrome, total bilirubin ≤ 3.0 × ULN).\n  3. Renal function: creatinine clearance rate (CrCl) ≥ 30 ml\u002Fmin (Cockcroft\u002FGault formula, excluding acute CrCl decline caused by the disease itself).\n* Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative Human chorionic gonadotropin (HCG) test within 7 days before study enrollment and not be lactating.\n* Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n* Subjects with a history of severe drug allergies or allergic tendencies.\n* Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections.\n* Subjects with central nervous system diseases caused by autoimmune diseases or non-autoimmune diseases (including epilepsy, psychosis, organic brain syndrome, cerebral vascular accidents, encephalitis, central nervous system vasculitis).\n* Subjects with insufficient cardiac function\n* Subjects with congenital immunoglobulin deficiencies\n* History of malignancy within five years\n* Subjects with end-stage renal failure\n* Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA \\>ULN; subjects positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; individuals positive for human immunodeficiency virus (HIV) antibody; individuals positive for syphilis testing\n* Subjects with psychiatric disorders and severe cognitive impairments\n* Subjects who have used immunosuppressive agents or biologics with therapeutic effects on the disease within five half-life before enrollment\n* Pregnant women or women planning to conceive\n* Active infection, active rheumatic and immune disease, drug induced and diagnosed lymphoproliferative tumor associated secondary AIHA patients\n* Subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study.",{"count":405,"type":20},15,[52],"This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19\u002FBCMA CAR T-cells in AIHA who have failed ≥ 3 lines of therapy.",[27,338,337],"2024-12-10",{"date":411,"type":32},"2024-12-13",{"date":413,"type":32},"2024-12-05",{"date":415,"type":20},"2026-12-05",{"name":63,"class":64},{"id":418,"slug":419,"hasResults":11,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":423,"eligibilityCriteria":424,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":425,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":426,"conditions":427,"keywords":430,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":90},"100510844","prospective-evaluation-of-diagnosis-and-treatment-of-patients-with-autoimmune-cytopenias-including-autoimmune-hemolytic-anemia-immune-thrombocytopenia-and-chronic-idiopathicautoimmune-neutropenia-100510844","NCT05931718","Prospective Evaluation of Diagnosis and Treatment of Patients With Autoimmune Cytopenias Including Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, and Chronic Idiopathic\u002FAutoimmune Neutropenia","Evaluation of the Diagnostic\u002FTherapeutic Course of Patients With Autoimmune Cytopenias (Autoimmune Hemolytic Anemia AIHA, Immune Thrombocytopenia ITP, Chronic Idiopathic\u002FAutoimmune Neutropenia CIN\u002FAIN) and Identification of Predictive and Prognostic Markers.","AIHA ITP CIN","Inclusion Criteria:\n\n* Diagnosis of autoimmune cytopenias (AIHA\u002FITP\u002FCIN\u002FAIN)\n* age \\>\u002F= 18 years\n* ability to sign informed consent\n* availability to undergo 3 year follow up\n* for the subgroup of patients with myelodysplastic syndrome: bone marrow evaluation showing \\>\u002F= 10% dysplastic features of at least one lineage along with MDS defining cytopenia and\u002For MDS defining cytogenetics.\n\nExclusion Criteria:\n\n* any condition impeding the acquisition of the informed consent\n* immune cytopenia diagnosis preceding \\>\u002F= 6 months the enrolment",{"count":356,"type":20},"The goal of this observational study is to characterize the diagnostic and therapeutic management of autoimmune cytopenias including autoimmune hemolytic anemia, immune thrombocytopenia, and chronic idiopathic\u002Fautoimmune neutropenia.\n\nThe main aims to answer are:\n\n* evaluation of traditional and novel diagnostic tools including immunohematology, cytokine essays, bone marrow studies, molecular findings, and fecal microbiome.\n* evaluation of type and sequence of the therapies administered, the response rates, and the adverse events.\n* evaluation of clinical and laboratory (immunologic, molecular, and morphologic) predictors of outcome.\n* evolution of autoimmune cytopenias into myelodysplastic syndromes.\n* a subgroup of patients with myelodysplastic syndromes will be included to evaluate the presence of immunologic events, autoimmune activation, and red cell metabolism.\n\nParticipants will receive a clinical\u002Flaboratory diagnostic workup as per current clinical practice. Furthermore They will be sampled at baseline (peripheral blood and feces for microbiome) and followed up for at least 3 years to evaluate their clinical course, therapeutic management and outcome.",[27,154,428,359,80,429],"Chronic Idiopathic Neutropenia","Cold Agglutinin Disease",[431,432,433,434,435,436,437,438,439,440,441,442,443,444,445,446,447],"autoimmune hemolytic anemia","immune thrombocytopenia","chronic idiopathic neutropenia","autoimmune neutropenia","cold agglutinin disease","myelodysplastic syndromes","rituximab","thrombopoietin receptor agonists","erythropoietin","steroids","splenectomy","red cell metabolism","cytokines","luspatercept","microbiome","single cell analysis","next generation sequencing","2024-10-08",{"date":450,"type":32},"2024-10-15",{"date":452,"type":32},"2019-06-01",{"date":454,"type":20},"2035-06",{"name":456,"class":64},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico",{"id":458,"slug":459,"hasResults":11,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":21,"phases":466,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":212},"100492604","phase-2-ibrutinib-for-the-treatment-of-aiha-in-patients-with-cllsll-or-cll-like-mbl-100492604","NCT05694312","Ibrutinib for the Treatment of AIHA in Patients With CLL\u002FSLL or CLL-like MBL","Ibrutinib for the Treatment of Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma or CLL-like Monoclonal B-cell Lymphocytosis","Inclusion Criteria:\n\n1. Diagnosis of CLL\u002Fsmall lymphocytic lymphoma (SLL) or CLL-like monoclonal B-cell lymphocytosis (MBL) according to IWCLL guidelines.\n2. Patients \\>18 years old\n3. Active AIHA (wAIHA or CAD) that i) is relapsed after previous treatment with corticosteroids (with or without rituximab), or ii) is steroid-resistant (failure to obtain hematologic response within 3 weeks on at least 1 mg\u002Fkg predniso(lo)ne), or iii) is steroid-dependent (need to continue on predniso(lo)ne at a dose of \\>10 mg\u002Fday to maintain a response). AIHA is defined as: anemia (hemoglobin ≤10 g\u002FdL; or hemoglobin \\>10 g\u002FdL dependent on transfusions to maintain this level of hemoglobin) and laboratory evidence of hemolysis (presence of 3 of 4 markers: increased reticulocyte count, increased indirect bilirubin, increased lactate dehydrogenase, decreased haptoglobin) and positive DAT (either IgG DAT, C3 DAT or both).\n4. Eligibility of patients with DAT-negative active AIHA should be confirmed by the Principal Investigator and co-Principal Investigator for the trial.\n5. Signed written informed consent according to ICH\u002FEU\u002FGCP and national local laws.\n\nExclusion Criteria:\n\n1. Contraindication to ibrutinib therapy as per treating physician's discretion.\n2. Contraindication to ibrutinib therapy as per ibrutinib data sheet (severe hepatic impairment, known allergy to the drug or to one of the excipients, concomitant treatment with warfarin or other vitamin K antagonists).\n3. Previous exposure to ibrutinib as CLL-directed therapy.\n4. Other CLL\u002FSLL- or AIHA-directed treatment at the time of enrollment in the study, other than corticosteroids.\n5. Female patients who are currently in pregnancy or are willing to be pregnant or are lactating.",{"count":465,"type":20},45,[23],"This is a multicenter, single arm, phase II study aimed at evaluating ibrutinib therapy for the treatment of AIHA in patients with CLL\u002FSLL or CLL-like MBL.",[27,469,470,471],"Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Monoclonal B-Cell Lymphocytosis CLL-Type","2023-11-28",{"date":474,"type":32},"2023-12-01",{"date":476,"type":32},"2023-11-24",{"date":478,"type":20},"2026-11",{"name":480,"class":64},"Gruppo Italiano Malattie EMatologiche dell'Adulto",{"id":482,"slug":483,"hasResults":11,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":487,"eligibilityCriteria":488,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":489,"enrollmentInfo":490,"targetDuration":492,"studyType":76,"phases":4,"briefSummary":493,"conditions":494,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":503},"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":491,"type":20},3500,"19 Years","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.",[154,27,127],"2023-07-07",{"date":497,"type":32},"2023-07-10",{"date":499,"type":32},"2010-09-01",{"date":501,"type":20},"2029-12-31",{"name":370,"class":64},9,{"id":505,"slug":506,"hasResults":11,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":510,"eligibilityCriteria":511,"healthyVolunteers":512,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":515,"conditions":516,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":4},"100425014","the-significance-of-release-of-t-follicular-helper-and-t-follicular-regulatory-cells-in-autoimmune-haemolytic-anemia-before-and-after-tratment-100425014","NCT04814394","The Significance of Release of T-follicular Helper and T-follicular Regulatory Cells in Autoimmune Haemolytic Anemia Before and After Tratment","The Significance of T-follicular Helper and T-follicular Regulatory Cells in Autoimmune Haemolytic Anemia","fhfr","Inclusion Criteria:\n\n* Patients diagnosed as autoimmune hemolytic anemia, primary or secondary, male or female, any age but not on treatment\n\nExclusion Criteria:\n\n* Pregnancy or breast-feeding women\n* Patients treated with corticoids or immunosuppressant.\n* Patients with hematological malignance.\n* Patients with alloimmune hemolytic anemia as ABO incompatibility or transplant patients",true,{"count":514,"type":20},50,"we study the circulating T-follicular regulatory and T-follicular regulatory cells in autoimmune hemolytic anemia.",[27],"2021-10-22",{"date":519,"type":32},"2021-10-26",{"date":521,"type":20},"2022-04-01",{"date":523,"type":20},"2026-12-01",{"name":525,"class":64},"Assiut University"]