[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aiha---warm-autoimmune-hemolytic-anemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aiha---warm-autoimmune-hemolytic-anemia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,71,97],{"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":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100633722","early-phase-1-ucar-t-cell-therapy-targeting-cd19bcma-in-relapsedrefractory-autoimmune-hemolytic-anemia-100633722",false,"NCT07530380","UCAR T-cell Therapy Targeting CD19\u002FBCMA in Relapsed\u002FRefractory Autoimmune Hemolytic Anemia","A Clinical Study of CD19\u002FBCMA-Targeted Universal Allogeneic CAR-T Cell Therapy in Relapsed\u002FRefractory Autoimmune Hemolytic Anima: Evaluating Safety and Preliminary Efficacy","Inclusion Criteria:\n\n* 1\\. Age ≥ 10 years, regardless of sex;\n* 2\\. Flow cytometry-confirmed CD19 or BCMA positivity on B cells in peripheral blood or bone marrow;\n* 3\\. 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* 4\\. The definition of recurrent\u002Frefractory AIHA that has received at least 3 failed lines of treatment is symptomatic anemia (hemoglobin\\\u003C100g\u002F L) 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* 5\\. Functional requirements for major organs are as follows:\n\n  1. The bone marrow function needs to meet: a Neutrophil count ≥ 1.0\n\n     × 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* 6\\. ECOG ≤ 2;\n* 7\\. 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* 8\\. 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* 1\\. Subjects with a history of severe drug allergies or allergic tendencies;\n* 2\\. Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections;\n* 3\\. History of recurrent infections (e.g., ≥3 episodes of active infection requiring medical intervention within 6 months prior to enrollment);\n* 4\\. History of cytomegalovirus (CMV), Epstein-Barr virus (EBV), or fungal infections within 3 months prior to screening, or history of recurrent CMV, EBV, or fungal infections;\n* 5\\. Receipt of any vaccination within 12 weeks prior to enrollment, or participation in a vaccine clinical trial within 12 weeks prior to enrollment;\n* 6\\. Subjects with insufficient cardiac function;\n* 7\\. Moderate to severe congestive heart failure (New York Heart Association \\[NYHA\\] Class III-IV);\n* 8\\. Subjects with congenital immunoglobulin deficiencies;\n* 9\\. History of malignancy within the past 5 years (except for non-melanoma skin cancer, completely resected Stage I tumor with low risk of recurrence, treated clinically localized prostate cancer, biopsy-proven cervical carcinoma in situ or squamous intraepithelial lesion on smear, and stable papillary or follicular thyroid cancer);\n* 10\\. 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* 11\\. History of organ transplantation, including but not limited to bone marrow or hematopoietic stem cell transplantation;\n* 12\\. Severe, progressive, uncontrolled disease of the cardiovascular, cerebrovascular, hepatic, renal, pulmonary, gastrointestinal, hematologic, endocrine, or nervous system;\n* 13.Psychiatric disorder or severe cognitive impairment;\n* 14\\. Pregnant women or women planning to conceive\n* 15\\. Subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study","ALL","10 Years",{"count":19,"type":20},15,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","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",[26,27],"AIHA - Warm Autoimmune Hemolytic Anemia","UCART",[29,27],"AIHA","RECRUITING","2026-04-08",{"date":33,"type":34},"2026-04-15","ACTUAL",{"date":36,"type":20},"2026-04",{"date":38,"type":20},"2030-12-31",{"name":40,"class":41},"The Second Hospital of Anhui Medical University","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100599397","phase-1-om336-in-autoimmune-cytopenias-100599397","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","18 Years","75 Years",{"count":53,"type":20},32,[55],"PHASE1","An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of subcutaneously dosed OM336 in adult participants with autoimmune cytopenias.",[26,58,59],"AIHA - Cold Autoimmune Hemolytic Anemia","ITP - Immune Thrombocytopenia","2025-09-24",{"date":62,"type":34},"2025-09-30",{"date":64,"type":34},"2025-08-01",{"date":66,"type":20},"2027-09",{"name":68,"class":69},"Ouro Medicines","INDUSTRY",3,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":42},"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":79,"type":20},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.",[26,58,83],"Autoimmune Hemolytic Anemia Mixed Type",[85,86,87],"Autoimmune Hemolytic Anemia","Treatment patterns","Hematologic response","2025-06-15",{"date":90,"type":34},"2025-06-17",{"date":92,"type":34},"2001-01-01",{"date":94,"type":20},"2070-12-31",{"name":96,"class":41},"Institute of Hematology & Blood Diseases Hospital, China",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":21,"phases":105,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":109,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":42},"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":104,"type":20},20,[106],"NA","To evaluate the efficacy and safety of ipecopam in the treatment of refractory\u002Frelapsed AIHA.",[26,58],"NOT_YET_RECRUITING","2025-02-21",{"date":112,"type":34},"2025-02-26",{"date":114,"type":20},"2025-03-01",{"date":116,"type":20},"2026-06-30",{"name":118,"class":41},"Bing Han"]