[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aiha---cold-autoimmune-hemolytic-anemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aiha---cold-autoimmune-hemolytic-anemia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,68,96],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100599397","phase-1-om336-in-autoimmune-cytopenias-100599397",false,"NCT07083960","OM336 in Autoimmune Cytopenias","An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants With Active Autoimmune Cytopenias","Key Inclusion Criteria:\n\n* Active autoimmune cytopenia\n* Relapsed\u002Frefractory after ≥1 prior treatment\n* Body weight ≥ 55 kg\n* Willing to comply with and study requirements and procedures\n\nKey Exclusion Criteria:\n\n* Previous treatment with a BCMA-targeted therapy\n* Clinically significant infection within 3 months of screening\n* Major surgery or splenectomy within 3 months of screening or planned during the study\n* Pregnant or breastfeeding","ALL","18 Years","75 Years",{"count":20,"type":21},32,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of subcutaneously dosed OM336 in adult participants with autoimmune cytopenias.",[27,28,29],"AIHA - Warm Autoimmune Hemolytic Anemia","AIHA - Cold Autoimmune Hemolytic Anemia","ITP - Immune Thrombocytopenia","RECRUITING","2025-09-24",{"date":33,"type":34},"2025-09-30","ACTUAL",{"date":36,"type":34},"2025-08-01",{"date":38,"type":21},"2027-09",{"name":40,"class":41},"Ouro Medicines","INDUSTRY",3,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100599967","phase-1-inaticabtagene-autoleucel-injection-in-the-treatment-of-autoimmune-hemolytic-anemia-after-three-or-more-lines-of-therapy-100599967","NCT07091370","Inaticabtagene Autoleucel Injection in the Treatment of Autoimmune Hemolytic Anemia After Three or More Lines of Therapy","A Multicenter, Open-label, Single-arm Phase I Clinical Trial on the Safety and Tolerability of Inaticabtagene Autoleucel Injection in the Treatment of Autoimmune Hemolytic Anemia That Has Failed at Least Three Lines of Treatment","Inclusion Criteria:\n\n1. Age range: 18-75 years (including 18 and 75 years), regardless of gender.\n2. Clinically diagnosed with AIHA or Evans, with hemoglobin lower than 100g\u002FL and symptoms related to anemia according to the diagnostic criteria of the \"Diagnosis and Treatment Guidelines for Autoimmune Hemolytic Anemia in Chinese Adults (2023 Edition)\" and the \"Chinese Expert Consensus on the Diagnosis and Treatment of Evans Syndrome (2024 Edition)\". And meet the diagnostic criteria of failure in at least three lines of treatment as follows:\n\n   Patients diagnosed with warm resistance type AIHA (wAIHA)\u002Fmixed AIHA (mAIHA) \u002FEvans syndrome, the following conditions must be met: first-line glucocorticoid treatment failed, second-line rituximab treatment failed and failure of third-line treatment measures (including any one or more of splenectomy, cyclosporine, cyclophosphamide, azathioprine, mycophenolate mofetil, fludarabine, bortezomib, etc.) Patients diagnosed with cold-resistant type AIHA (cAIHA), that is, cold agglutinin disease (CAD), the following conditions must be met: first-line rituximab treatment failed, second-line rituximab ± bendamustine\u002Ffludarabine failed and failure of third-line treatment measures (including any one or more of bortezomib, cyclosporine, cyclophosphamide, mycophenolate mofetil, azathioprine, etc.)\n3. Women of childbearing potential must have a negative blood pregnancy test during the screening period. Any male and female patients of childbearing potential must agree to use an effective method of contraception throughout the study and for at least 2 year following infusion of CAR-T cells. Childbearing potential is biologically capable of bearing a living baby and sexually active. Female patients who were not of childbearing potential (ie, met at least 1 of the following criteria):\n\n   Hysterectomy or oophorectomy, or medically confirmed ovarian failure, or medically confirmed postmenopausal (cessation of menses for at least 12 consecutive months in the absence of pathological or physiological causes).\n4. Adequate organ function according to the following criteria:\n\n   Aspartate aminotransferase (AST) ≤ 3 times of upper limit of normal (ULN); Alanine aminotransferase (ALT) ≤ 3 times ULN; Serum creatinine ≤ 1.5 times ULN, or creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft and Gault formula); International normalized ratio (INR) ≤ 1.5 times ULN, and activated partial thromboplastin time (APTT) ≤ 1.5 times the ULN; Must have minimal pulmonary reserve and oxygen saturation \\> 93% in a nonoxygenated state;\n5. The Eastern Cancer Consortium (ECOG) performance status score is 0-2.\n\nExclusion Criteria:\n\n1. Previously diagnosed proliferative tumors of the lymphatic system;\n2. Secondary AIHA caused by drugs or infections;\n3. Pregnancy or breastfeeding;\n4. Previously undergone organ or hematopoietic stem cell transplantation;\n5. A history of new thrombosis or organ infarction within 6 months prior to screening;\n6. The active stage diagnosed as a connective tissue disease;\n7. Suffering from hereditary hemolytic diseases or other acquired hemolytic diseases;\n8. Combined with active infections (such as sepsis, bacteremia, mycosis, uncontrolled pulmonary infection and active tuberculosis, etc.);\n9. Positive for hepatitis B surface antigen (HBsAg) and\u002For hepatitis Be antigen (HBeAg); Hepatitis Be antibody (HBe-Ab) and\u002For hepatitis B core antibody (HBc-Ab) are positive, and the HBV-DNA copy number is greater than the measurable lower limit; Positive for hepatitis C (HCV) antibody; Positive for human immunodeficiency virus (HIV) antibody; Those with positive syphilis (TP) test;\n10. Major surgery that was assessed as unsuitable by the investigators within 4 weeks before screening;\n11. Patients with concurrent active malignancy within the past five years, those with a history of malignancy but cuired are eligible.\n12. The patient's heart meets any of the following conditions:\n\n    * Left ventricular ejection fraction (LVEF) ≤45%;\n    * New York Heart Association (NYHA) grade III or IV congestive heart failure or active heart disease;\n    * Severe arrhythmias requiring treatment (excluding atrial fibrillation and paroxysmal supraventricular tachycardia);\n    * The QTcB interval was ≥450ms for males and ≥470ms for females (QTcB=QT\u002F R1\u002F2);\n    * Had myocardial infarction, bypass surgery or stent surgery within 6 months before the study;\n    * Other heart diseases judged by the researchers as unsuitable for inclusion in the group;\n13. Have received live vaccines within 6 weeks before screening.\n14. Patients participating in any other interventional clinical study or receiving treatment of an active investigational drug within 3 months or 5 half-lives for launched drugs prior to Inaticabtagene Autoleucel Injection infusion.\n15. Patients with a history of epilepsy, cerebral ischemia\u002Fhemorrhage, cerebellar diseases, or other active central nervous system disorders;\n16. Patients with hypersensitivity reactions to the components of Inaticabtagene Autoleucel Injection;\n17. Patients previously received CAR-T cell therapy.\n18. Other circumstances where the researcher deems it inappropriate to participate in this clinical trial.",{"count":51,"type":21},12,[24],"This is a multicenter, open-label, single-arm Phase I clinical trial to evaluate the safety and tolerability of Inaticabtagene Autoleucel Injection treatment in autoimmune hemolytic anemia that has failed at least three lines of treatment.",[28],[56,57],"AIHA","CarT","NOT_YET_RECRUITING","2025-09-17",{"date":61,"type":34},"2025-09-22",{"date":63,"type":21},"2025-12-27",{"date":65,"type":21},"2028-03-30",{"name":67,"class":41},"Juventas Cell Therapy Ltd.",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":95},"100594407","national-longitudinal-cohort-of-hematological-diseases--autoimmune-hemolytic-anemia-100594407","NCT07019038","National Longitudinal Cohort of Hematological Diseases- Autoimmune Hemolytic Anemia","NICHE-AIHA","Inclusion Criteria:\n\n* Subjects diagnosed with AIHA.\n* Hemoglobin\\\u003C100g\u002FL\n* Subjects treated at the Institute of Hematology and Blood Diseases Hospital from Jan 1, 2001.\n\nExclusion Criteria:\n\n* Subject unlikely to be available for long-term follow-up for any reason (e.g., inability to obtain follow-up data or presence of severe comorbidities).\n* Subject with alcohol or drug dependence may reduce their compliance with the study.\n* Subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study.",{"count":76,"type":21},9999,"OBSERVATIONAL","Hematological diseases are disorders of the blood and hematopoietic organs. The current hematological cohorts are mostly based on single-center or multi-center cases, or cohorts with limited sample size in China. There is a lack of comprehensive and large-scale prospective cohort studies in hematology.\n\nThe objectives of this study are to investigate the incidence and risk factors of autoimmune hemolytic anemia (AIHA) and to analyze the treatment effectiveness, patient prognosis and healthcare costs in China.\n\n1. Analyze the demographic and clinical characteristics of patients with AIHA, including sex, age, disease severity, and other relevant factors.\n2. Examine disease features of AIHA patients, such as biochemical and hematological indicators\n3. Assess treatment patterns and real-world effectiveness in AIHA patients.\n4. Evaluate clinical outcomes, including hematologic response, relapse, and mortality\n5. Investigate long-term prognosis, including post-discontinuation outcomes and health-related quality of life.",[27,28,80],"Autoimmune Hemolytic Anemia Mixed Type",[82,83,84],"Autoimmune Hemolytic Anemia","Treatment patterns","Hematologic response","2025-06-15",{"date":87,"type":34},"2025-06-17",{"date":89,"type":34},"2001-01-01",{"date":91,"type":21},"2070-12-31",{"name":93,"class":94},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",1,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":95},"100581230","a-multicenter-prospective-study-of-iptacopan-in-the-treatment-of-refractoryrelapsed-autoimmune-hemolytic-anemia-aiha-100581230","NCT06847607","A Multicenter Prospective Study of Iptacopan in the Treatment of Refractory\u002FRelapsed Autoimmune Hemolytic Anemia (AIHA)","Inclusion Criteria:\n\n1. Voluntarily signed an informed consent form (ICF);\n2. Males or females aged 18 or older;\n3. Physical status score \\[Eastern Cooperative Oncology Group (ECOG) score\\] ≤2;\n4. Confirmed diagnosis of primary AIHA or secondary autoimmune disease (except rheumatoid arthritis and systemic lupus erythematosus) with underlying disease in a stable state;\n5. Poor response to at least previous glucocorticoid therapy, including ineffective (defined as failure to achieve stabilization of Hb levels at 100 g\u002FL or erythrocyte hematocrit \\\u003C30% despite at least 4 weeks of treatment with previously recommended doses), or glucocorticoid-dependent (defined as maintenance of equal doses of prednisone exceeding 15 mg\u002Fd), or relapsed (defined as treatment that is effective and then again has an Hb of \\\u003C100 g\u002FL or an erythrocyte hematocrit of \\\u003C30%), or otherwise contraindicated. 30%), or otherwise contraindicated or intolerant to glucocorticoid therapy;\n6. Hemoglobin (Hb) \\\u003C100 g\u002FL before drug administration;\n7. Positive direct anti-human globulin test (DAT) (IgA, IgM or IgG+, with or without C3+).\n8. Combination of one anti-AIHA therapy \\[glucocorticoids only (≤15 mg prednisone equivalent), immunosuppressants (azathioprine, cyclosporine, and merti-macrolide only)\\] is permitted in this study, provided that the dose has been stable for at least 28 days prior to enrollment;\n9. Laboratory tests meet the following criteria (no treatment for the abnormality of the index within 2 weeks prior to blood collection, or no long-acting G-CSF treatment within 2 weeks)\n\n   1. Neutrophil count \\>1.5×109\u002FL and platelet \\>30×109\u002FL;\n   2. ALT and AST ≤ 2 × ULN;\n   3. Serum creatinine concentration ≤ 2 × ULN and creatinine clearance ≥ 50mL\u002Fmin;\n10. No active infection; no pregnancy or lactation;\n11. cAIHA patients presenting with skin cyanosis and thrombosis;\n12. Written evidence of Neisseria meningitidis and Streptococcus pneumoniae vaccinations within 2 years or, if none, antibiotic prophylaxis until 2 weeks after completion of vaccination.\n\nExclusion Criteria:\n\n1. Presence of secondary AIHA outside the inclusion criteria;\n2. Hb \\\u003C100 g\u002FL due to non-AIHA factors; and\n3. Infections requiring systemic therapy;\n4. Those with a past history of malignancy (except cured basal cell carcinoma of the skin or cervical carcinoma in situ);\n5. With history of vital organ transplantation or hematopoietic stem cell\u002Fbone marrow transplantation;\n6. Those who have undergone splenectomy within 24 weeks prior to enrollment;\n7. Those who have had major surgery within four weeks prior to enrollment or who require major elective surgery during the study period;\n8. History of severe cardiovascular disease \\[e.g., class III\u002FIV congestive heart failure, arrhythmia or angina requiring medication, unstable angina, coronary stenting, angioplasty or coronary artery bypass grafting, or corrected Q-T interval (QTcF) ≥ 90 mmHg\\]\n9. Patients with medically uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg); or comorbid portal hypertension;\n10. Patients with severe gastrointestinal disorders such as dysphagia, active gastric ulcers, etc., who are unable to take drugs orally or have impaired absorption of oral drugs;\n11. Human immunodeficiency virus (HIV) infection\n12. Uncontrolled or active HBV infection \\[Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) positive patients, need to confirm Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) positive\\]; or Hepatitis C \\[patients with Hepatitis C Virus Ribonucleic Acid (HCV RNA) positive patients\\]; or cirrhosis of the liver;\n13. Those who had received herbal treatment within one week prior to enrollment that interfered with the assessment of efficacy;\n14. Patients with severe psychological or psychiatric abnormalities;\n15. Alcohol or drug abusers;\n16. Female patients who are pregnant or breastfeeding;\n17. Patients who, in the opinion of the investigator, are not suitable for participation in this study.",{"count":103,"type":21},20,[105],"NA","To evaluate the efficacy and safety of ipecopam in the treatment of refractory\u002Frelapsed AIHA.",[27,28],"2025-02-21",{"date":110,"type":34},"2025-02-26",{"date":112,"type":21},"2025-03-01",{"date":114,"type":21},"2026-06-30",{"name":116,"class":94},"Bing Han"]