[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"autoimmune-hemolytic-anemia-aiha\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:autoimmune-hemolytic-anemia-aiha":177},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,46,77,102,127,151],{"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":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100627802","phase-2-orelabrutinib-in-the-treatment-of-relapsedrefractory-aiha-100627802",false,"NCT07453368","Orelabrutinib in the Treatment of Relapsed\u002FRefractory AIHA","Orelabrutinib in the Treatment of Relapsed\u002FRefractory Autoimmune Hemolytic Anemia: A Prospective, Dose-Escalation Cohort Study","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Patients with a definitive diagnosis of AIHA. wAIHA or Evans syndrome, primary or secondary to connective tissue disease (CTD) or lymphoproliferative disorder (LPD). If secondary, CTD should have no indication for treatment for other system involvement, and LPD should be in an asymptomatic, observation phase without treatment indication.\n\ncAIHA, primary or secondary to LPD. If secondary, LPD should be in an asymptomatic, observation phase without treatment indication.\n\n* For wAIHA: No response (no partial response after 3 weeks) to full-dose glucocorticoid therapy (1-2 mg\u002Fkg\u002Fday), intolerance, or relapse (after initial response, hemoglobin drop ≥20 g\u002FL or requiring re-initiation of immunosuppressive therapy). And hemoglobin ≤ 100 g\u002FL.\n* For cAIHA: No response or relapse after anti-CD20 monoclonal antibody therapy (after initial response, hemoglobin drop ≥20 g\u002FL or recurrence of vascular symptoms, or requiring re-initiation of immunosuppressive therapy), or unsuitable for anti-CD20 therapy. And hemoglobin ≤ 100 g\u002FL or presence of vascular symptoms.\n* Baseline liver and kidney function (ALT, Cr) within 2 times the upper limit of normal (elevated AST, LDH, Bil due to hemolysis are not used as indicators for liver function assessment).\n* Agreement to sign the informed consent form.\n\nExclusion Criteria:\n\n* Active involvement of other major organs due to connective tissue disease.\n* Uncontrolled infection or bleeding per standard treatment.\n* Uncontrolled active HIV, HCV, or HBV infection per standard treatment.\n* Concurrent advanced uncontrolled malignancy, lymphoma.\n* Presence of other uncorrected types of anemia at screening, such as nutritional anemia, thalassemia, etc.\n* Currently receiving glucocorticoid therapy at screening and unable to discontinue or taper to ≤ 15 mg\u002Fday (prednisone equivalent) within 1 week before enrollment.\n* Currently receiving treatment with medications such as cyclosporine, tacrolimus, sirolimus, cyclophosphamide, azathioprine, stanozolol, testosterone undecanoate, danazol, etc., at screening, and the treatment duration at a stable dose is \\\u003C 12 weeks, or unable to discontinue directly.\n* Last dose of rituximab \\\u003C 3 months prior to enrollment.\n* Prior treatment with any BTK inhibitor.\n* Liver cirrhosis or portal hypertension.\n* Pregnant or breastfeeding women.\n* Participation in another clinical trial within the past 3 months.","ALL","18 Years","85 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","1. wAIHA Treatment Regimen: Group A (50mg group): Orelabrutinib 50 mg, orally, once daily. After 4 weeks of treatment, if still transfusion-dependent or hemoglobin increase is \\\u003C 20 g\u002FL, the dose may be increased to 100 mg qd. Treatment can be discontinued if ineffective at 12 weeks.\n\n   Group B (100mg group): Orelabrutinib 100 mg, orally, once daily. The treatment course is at least 12 weeks. Treatment can be discontinued if ineffective at 12 weeks. Patients who respond and tolerate the drug well may continue treatment for up to 52 weeks or longer to observe long-term efficacy and safety.\n2. cAIHA Treatment Regimen: Group C (150mg group): Orelabrutinib 150 mg, orally, once daily. The treatment course is at least 12 weeks. Patients who respond and tolerate the drug well may continue treatment for up to 52 weeks or longer to observe long-term efficacy and safety.",[27],"Autoimmune Hemolytic Anemia (AIHA)",[29,30,31,32],"Autoimmune Hemolytic Anemia","Orelabrutinib","Treatment","Cohort Study","RECRUITING","2026-06-15",{"date":36,"type":37},"2026-06-16","ACTUAL",{"date":39,"type":37},"2026-03-01",{"date":41,"type":21},"2028-03-01",{"name":43,"class":44},"Peking Union Medical College Hospital","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":45},"100640920","early-phase-1-evaluation-of-safety-pharmacokinetics-and-pharmacodynamics-of-arnovie101-an-mrna-lnp-based-in-vivo-car-t-therapy-for-the-treatment-of-b-cell-mediated-autoimmune-diseases-sle-and-aiha-100640920","NCT07629596","Evaluation of Safety, Pharmacokinetics and Pharmacodynamics of Arnovie101, an mRNA-LNP-Based In Vivo CAR-T Therapy, for the Treatment of B Cell-Mediated Autoimmune Diseases (SLE and AIHA)","Evaluation of Safety, Pharmacokinetics and Pharmacodynamics of Arnovie101, an mRNA-LNP-Based In Vivo CAR-T Therapy, for the Treatment of B Cell-Mediated Autoimmune Diseases (Systemic Lupus Erythematosus and Autoimmune Hemolytic Anemia)","Inclusion Criteria:\n\n1. Ability to voluntarily sign informed consent, including compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and this protocol.\n2. Male or female, aged 18 to 60 years (inclusive) at screening.\n3. Participants with relapsed\u002Frefractory SLE with at least 6 months of disease history and meeting the following criteria:\n\n   A. Confirmed diagnosis of SLE according to the 2012 SLICC or 2019 EULAR\u002FACR revised criteria. SLEDAI-2K score ≥6 at screening. If the score includes low complement and\u002For anti-dsDNA antibodies, the clinical symptom score of SLEDAI-2K (excluding low complement and\u002For anti-dsDNA antibodies) should be ≥4. Poor response to standard therapy (at least two first-line treatments, including corticosteroids and immunosuppressants) and disease relapse after treatment.\n\n   B. SLE: Stable standard therapy (including non-steroidal anti-inflammatory drugs, immunosuppressants, biologics, and glucocorticoids; oral glucocorticoid dose of prednisone or equivalent ≥7.5 mg\u002Fday and ≤30 mg\u002Fday; if combined with an immunosuppressant, no minimum daily dose requirement) for at least 8 weeks before screening, with current dose stable for at least 2 weeks and expected to remain stable during the study. Prior use of at least two immunosuppressants including hydroxychloroquine.\n\n   C. Life expectancy \\>6 months.\n4. Participants with AIHA meeting the following criteria:\n\n   A. Participants with AIHA or Evans syndrome who have failed ≥3 lines of therapy.\n\n   B. Failure of ≥3 lines of therapy must meet all of the following: hemoglobin \\\u003C10 g\u002FdL with symptoms of anemia; failure of first-line corticosteroid therapy; failure of second-line rituximab therapy; failure of any one or more third-line regimens (splenectomy, cyclosporine, cyclophosphamide, azathioprine, mycophenolate mofetil, fludarabine, bortezomib, etc.).\n\n   C. Life expectancy \\>3 months.\n5. Adequate organ function:\n\n   A. Renal function: Calculated creatinine clearance (Cockcroft-Gault) ≥30 mL\u002Fmin without hydration support.\n\n   B. Bone marrow function: Absolute neutrophil count (ANC) ≥1.0×10⁹\u002FL, absolute lymphocyte count (ALC) ≥0.1×10⁹\u002FL, hemoglobin (Hb) ≥60 g\u002FL, platelet count (PLT) ≥20×10⁹\u002FL. Coagulation: International normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5×ULN. Note: No blood transfusion, white blood cell growth factors (e.g., colony-stimulating factors), erythropoietin, or thrombopoietin within 7 days before the laboratory assessment.\n\n   C. Hepatic function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, total bilirubin \\\u003C2.0 mg\u002FdL (for participants with Gilbert's syndrome, total bilirubin \\\u003C3.0 mg\u002FdL; except when caused by SLE itself).\n\n   D. Pulmonary function: Dyspnea ≤CTCAE grade 1 and oxygen saturation (SpO₂) ≥92% on room air (measured by pulse oximeter).\n6. Female participants must meet the following criteria: 1) Not pregnant or breastfeeding; 2) Surgically sterile or postmenopausal for ≥2 years, or if of childbearing potential (including those postmenopausal \\\u003C2 years), have a negative serum pregnancy test (β-hCG) and agree to use effective contraception (e.g., condom, spermicide, or intrauterine device) during the study and for at least 12 months after the last dose. Use of progesterone-only contraceptives is not permitted; 3) Agree not to breastfeed during the study and for at least 12 months after the last dose.\n7. Male participants must meet the following criteria: If not surgically sterile and engaging in sexual activity that could lead to pregnancy, agree to use effective contraception (e.g., condom, spermicide) during the study and for at least 12 months after the last dose, and refrain from donating semen or sperm during the study and for 12 months after the last dose.\n\nExclusion Criteria:\n\n1. Presence of an unresected thymoma.\n2. Pregnant or lactating women.\n3. History of active severe or unstable neuropsychiatric SLE, including but not limited to poorly controlled seizures, psychosis, acute confusional state, cerebrovascular accident, demyelinating syndrome, cranial neuropathy, or active central nervous system vasculitis.\n4. Presence of clinically significant central nervous system disease or pathology before screening, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, convulsions\u002Fseizures, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.\n5. History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell\u002Fbone marrow transplantation.\n6. Presence of known active infection at screening, including active tuberculosis, active or infectious pneumonia, or recurrent peptic ulcer; requiring hospitalization, intravenous antibiotics within 4 weeks before screening, or oral antibiotics within 2 weeks before screening; history of herpes zoster within 12 weeks before screening; history of human immunodeficiency virus (HIV) or positive HIV antibody test; positive hepatitis B surface antigen (HBsAg) and\u002For positive anti-hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA above the lower limit of detection; positive hepatitis C virus (HCV) antibody with detectable HCV RNA above the lower limit of detection; positive syphilis antibody with active infection.\n7. History of any of the following cardiovascular diseases within 6 months before screening: New York Heart Association (NYHA) class II or higher heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias (e.g., second-degree type II atrioventricular block, third-degree atrioventricular block, symptomatic bradycardia with ventricular rate \\\u003C50 bpm), any ventricular arrhythmia, or other clinically significant heart disease. QTcF \\>480 ms (Fridericia's formula), left ventricular ejection fraction (LVEF) \\\u003C50% by echocardiography at screening, or other significant electrocardiogram abnormalities.\n8. Malignancy within 5 years before signing the ICF, except for: curatively treated basal cell carcinoma of the skin, superficial bladder cancer, localized prostate cancer, biopsy-proven cervical carcinoma in situ or cervical squamous intraepithelial lesion detected by Pap smear, and completely resected ductal carcinoma in situ of the breast.\n9. Previous treatment with B-cell targeted therapies such as belimumab, rituximab, telitacicept; anti-CD22 agents (e.g., epratuzumab); anti-CD52 agents (e.g., alemtuzumab), or other similar biologics; TNF-α antagonists, IL-6 antagonists, IL-1 antagonists, selective T-cell costimulation modulators, etc., with less than 5 half-lives before screening.\n10. Use of any other investigational drug for SLE in a clinical trial within 4 weeks before screening.\n11. Presence of other serious diseases, including liver disease, neurological\u002Fpsychiatric disorders, endocrine system disorders, hematological disorders (including moderate-to-severe dyslipidemia and related conditions), which in the investigator's judgment would affect participation in this study.\n12. Receipt of non-biologic investigational drugs (e.g., BTK inhibitors, JAK inhibitors), intravenous immunoglobulin, or plasma exchange within 4 weeks or 5 half-lives (whichever is shorter) before screening.\n13. Vaccination within 30 days before the first dose of study drug.\n14. Prior treatment with mRNA-LNP or other LNP-based drugs within 2 years before the first dose of study drug.\n15. History of asthma, severe allergic reactions, or known allergy to any active or inactive ingredient of the study drug (including background therapy).\n16. Prior CAR-T cell therapy.\n17. Major surgery within 4 weeks before the first dose of study drug, or minor surgery within 2 weeks before the first dose.\n18. Severe mental disorder or suicidal tendency.\n19. Any other condition that, in the investigator's judgment, makes the participant unsuitable for this study.","60 Years",{"count":55,"type":21},5,[57],"EARLY_PHASE1","This is an open lable and single arm study designed to evaluate the safety, PK and PD of Arnovie101 in B cell-mediated Autoimmune Disease",[60,27],"Systemic Lupus Erythematosus",[62,63,64,65,66],"SLE","AIHA","in vivo CAR-T","mRNA-LNP","autoimmune diseases","2026-06-01",{"date":69,"type":37},"2026-06-05",{"date":71,"type":37},"2026-04-07",{"date":73,"type":21},"2027-05-30",{"name":75,"class":76},"Circunited BioPharma (Shenzhen) Co., Ltd.","INDUSTRY",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100608727","early-phase-1-a-clinical-study-evaluating-the-safety-and-efficacy-of-gt801-injection-in-adult-patients-with-relapsedrefractory-cd19-positive-b-cell-hematologic-malignancies-and-autoimmune-hemolytic-anemia-100608727","NCT07205315","A Clinical Study Evaluating the Safety and Efficacy of GT801 Injection in Adult Patients With Relapsed\u002FRefractory CD19-positive B-cell Hematologic Malignancies and Autoimmune Hemolytic Anemia","Inclusion Criteria:\n\n* Aged 18 to 75 years (inclusive), male or female;\n* Participants with refractory or relapsed acute B-cell lymphoblastic leukemia (B-ALL), Chronic Lymphocytic Leukemia (CLL), B-cell Non-Hodgkin's Lymphoma (B-NHL) confirmed by the WHO 2016 Classification, or Autoimmune Hemolytic Anemia (AIHA) diagnosed in accordance with international consensus;\n* Disease progression or recurrence after at least second-line drug treatment;\n* CD19 positivity confirmed by flow cytometry and\u002For histopathology (excluding autoimmune hemolytic anemia);\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1(excluding autoimmune hemolytic anemia);\n* Expected survival period \\> 12 weeks\n* For participants with hematological malignancies, the following requirements must be met:\n\nFor any prior systemic therapy (excluding immune checkpoint inhibitors), an interval of at least 2 weeks or 5 half-lives (whichever is shorter) must have elapsed between the last dose of such therapy and the planned initiation of study treatment.\n\nFor any prior treatment with immune checkpoint inhibitors (e.g., anti-PD-1\u002FPD-L1 monoclonal antibodies such as pembrolizumab, OX40 agonists, 4-1BB agonists, etc.), an interval of at least 3 half-lives or 28 days (whichever is shorter) must have elapsed between the last dose of such treatment and the planned initiation of study treatment.\n\n• For participants with autoimmune hemolytic anemia (AIHA), the following requirements must be met: The total course of glucocorticoid therapy shall be no less than 3 months (except for those who are unable to tolerate due to severe infection, fracture, etc.); Rituximab (100 mg or 375 mg\u002Fm²) shall be administered for at least 4 times, with hemoglobin (HB) remaining below 100 g\u002FL at 12 weeks after the first dose; or rituximab (1000 mg per administration) shall be administered for at least 2 times, with hemoglobin (HB) remaining below 100 g\u002FL at 12 weeks after the first dose; oral administration of any one of the following drugs including mycophenolate mofetil, cyclosporine, azathioprine, cyclophosphamide, etc., shall last for at least 4 months or be discontinued due to intolerance; or intravenous therapy with fludarabine or cyclophosphamide injection shall be administered for at least 2 cycles; or subcutaneous injection of bortezomib shall be administered for at least 4 times.\n\nExclusion Criteria:\n\n* Participants with a history of central nervous system leukemia\u002Flymphoma, or those with central nervous system (CNS) leukemia\u002Flymphoma shown by magnetic resonance imaging (MRI) or PET-CT intracranial imaging during the screening period, or those with detectable malignant cells in cerebrospinal fluid or brain metastases;\n* Subjects with myelofibrosis, myelodysplastic syndromes, aplastic anemia, or other malignant hematological diseases;\n* Subjects with a history of or current comorbidities that cause coagulation disorders and high bleeding risk, such as disseminated intravascular coagulation (DIC), decompensated cirrhosis, esophagogastric varices, etc.;\n* Subjects who experienced severe bleeding (defined as bleeding uncontrollable by medication or local therapy) within 4 weeks prior to screening, or have life-threatening bleeding (associated with thrombocytopenia) currently, or are expected to require emergency treatment within one week after enrollment;\n* Subjects with secondary AIHA induced by drugs or infections;\n* Subjects with hereditary hemolytic diseases or other acquired hemolytic diseases.\n* Participants who undergo hematopoietic stem cell transplantation with therapeutic intent within 12 weeks of planned GT801 infusion;\n* If the participant has a history of hematopoietic stem cell transplantation, the time since the participant received allogeneic hematopoietic stem cell transplantation is ≤ 6 months;\n* Administration of hormonal drugs in any form within 14 days prior to infusion (except for AIHA participants requiring such drugs for hemolysis control and those receiving them for preconditioning).\n* Active hepatitis B and\u002For active hepatitis C (HCV RNA positive); participants who are positive for hepatitis B surface antigen and\u002For core antibody but have HBV-DNA test results within the normal range can be included; participants who are positive for hepatitis C virus (HCV) antibody but with HCV RNA test results within the normal range are eligible for inclusion.\n* Presence of central nervous system diseases or a history thereof, such as epileptic seizures, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar diseases, or any autoimmune diseases involving the central nervous system;\n* Presence of any of the following conditions within 6 months before signing the informed consent form: uncontrolled congestive heart failure (New York Heart Association Class III-IV), angina pectoris, myocardial infarction, cardiomyopathy, stroke (except lacunar infarction), coronary\u002Fperipheral artery bypass surgery, arrhythmias with significant clinical significance (as judged by the investigator) including but not limited to ventricular arrhythmias, significantly prolonged QT interval (recommended QTc ≥ 500ms corrected by Bazett's method, specifically judged by the investigator), poorly controlled hypertension (systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg), poorly controlled diabetes, pulmonary embolism, diffuse pulmonary lesions, pulmonary insufficiency, or medical conditions that the investigator deems unsuitable for the participant to participate in this clinical study;\n* Prior receipt of gene-modified or gene-edited cellular therapy products (except for autologous immune cell therapy products without gene modification or editing, provided that the interval from the last administration to the first dose of GT801 is more than 1 year).\n* A history of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus) that caused end-organ damage or required systemic immunosuppression\u002Fsystemic disease-modifying agents within the past 2 years.","75 Years",{"count":85,"type":21},28,[57],"The goal of this clinical study is to evaluate the safety and efficacy of GT801 injection in adult patients with relapsed\u002Frefractory CD19-positive B-cell hematologic malignancies and autoimmune hemolytic anemia. Interim analysis conducted when 2 patients complete primary endpoint measurement.",[89,90,91,27],"B-cell Acute Lymphoblastic Leukemia (B-ALL)","Chronic Lymphocytic Leukemia (CLL)","B-cell Non-Hodgkin's Lymphoma (B-NHL)","2026-05-22",{"date":94,"type":37},"2026-05-27",{"date":96,"type":37},"2025-09-26",{"date":98,"type":21},"2028-08-31",{"name":100,"class":76},"Grit Biotechnology",2,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":123,"leadSponsor":125,"locationsCount":4},"100639937","phase-1-cd20-monoclonal-antibody-combined-with-btk-inhibitor-for-the-treatment-of-refractory-immune-related-cytopenia-100639937","NCT07574073","CD20 Monoclonal Antibody Combined With BTK Inhibitor for the Treatment of Refractory Immune-related Cytopenia","Clinical Study on the Treatment of Refractory Immune-related Cytopenia With CD20 Monoclonal Antibody Combined With BTK Inhibitor (BTKi)","Inclusion Criteria:\n\n* Diagnosed with refractory immune-related cytopenia, including immune thrombocytopenic purpura (ITP) and autoimmune hemolytic anemia (AIHA);\n* Age ranging from 18 to 80 years old (inclusive of 18 and 80);\n* Expected survival time \\> 12 months;\n* Good function of major organs:\n\n  1. liver function: ALT\u002FAST \\\u003C 3 times the upper limit of normal;\n  2. kidney function: creatinine \\\u003C 100 μmol\u002FL;\n  3. lung function: indoor oxygen saturation ≥ 95%;\n  4. heart function: left ventricular ejection fraction (LVEF) ≥ 50%;\n* Peripheral superficial venous blood flow is unobstructed, capable of meeting the requirements for intravenous infusion;\n* Karnofsky score ≥ 60, ECOG ≤ 2 points.\n\nExclusion Criteria:\n\n* Women who are pregnant (with positive urine\u002Fblood pregnancy test results) or breastfeeding;\n* Those who have severe underlying heart diseases when participating in this study, including:\n\n  1. clinically significant atrial fibrillation (AF),\n  2. cardiac conduction block,\n  3. myocardial infarction (within 1 year),\n  4. congestive heart failure (CHF);\n  5. cardiac echocardiography LVEF \\\u003C 50%;\n  6. New York Heart Association (NYHA) cardiac function classification of III-IV grade;\n* Those with active bleeding or bleeding tendencies, and those who need to take anticoagulant drugs;\n* Those with organ dysfunction or uncontrollable coexisting diseases;\n* History of malignant tumors;\n* Those with active chronic hepatitis B or active hepatitis C;\n* Known history of human immunodeficiency virus (HIV) infection and\u002For acquired immunodeficiency syndrome;\n* Those with uncontrollable infectious diseases;\n* As determined by the investigator, other unsuitable conditions exist.","80 Years",{"count":111,"type":21},30,[113],"PHASE1","This study aims to utilize anti-CD20 monoclonal antibodies to eliminate peripheral B cells and reduce the mechanism of autoantibody production, as well as combine the mechanism of BTK inhibitors (BTKi) blocking the B cell receptor signaling pathway and inhibiting B cell activation and proliferation, for the treatment of refractory immune-related cytopenia. In this study, it includes the salvage treatment of immune thrombocytopenia (ITP) and autoimmune hemolytic anemia (AIHA), expecting to achieve a synergistic and enhancing effect. This study aims to select Zuberitamab, a human-mouse chimeric anti-CD20 monoclonal antibody, and the BTKi Orelabrutinib as combination therapy options. The clinical efficacy of the Zuberitamab-Orelabrutinib combination therapy (overall response rate, duration of sustained remission) will be evaluated, along with its safety profile (including infections, bleeding, cardiac toxicity), to provide a theoretical basis for their combined use in treating refractory immune-related thrombocytopenia (ITP and AIHA).",[116,117,118,27],"Anti-CD20 Monoclonal Antibody","BTK Inhibitors","Immune Thrombocytopenia (ITP)","NOT_YET_RECRUITING","2026-05-19",{"date":92,"type":37},{"date":67,"type":21},{"date":124,"type":21},"2028-05-31",{"name":126,"class":44},"Qi deng",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":83,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":138,"conditions":139,"keywords":140,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":45},"100632791","a-multicenter-prospective-randomized-controlled-study-comparing-glucocorticoid-combined-with-sirolimus-with-monotherapy-of-glucocorticoid-in-the-treatment-of-newly-diagnosed-mild-autoimmune-hemolytic-anemia-100632791","NCT07518277","A Multicenter, Prospective, Randomized Controlled Study Comparing Glucocorticoid Combined With Sirolimus With Monotherapy of Glucocorticoid in the Treatment of Newly Diagnosed Mild Autoimmune Hemolytic Anemia","sirolimus","Inclusion Criteria:\n\n1. Age ≥18 years old, gender not limited;\n2. Diagnosed as newly diagnosed wAIHA and requiring systemic immunosuppressive therapy (those with short-term hormone exposure of ≤2 weeks before enrollment can be included)\n3. After a comprehensive rheumatology and immunology assessment, there is no evidence of clinical organ involvement in SLE or other connective tissue diseases (only serological abnormalities can be included).\n4. Positive Coombs test (IgG type, IgG+C3d type, or only C3d type with a condensed agglutinin titer of 1:64);\n5. Active hemolytic anemia, hemoglobin (HGB) ≤ 100 g\u002FL;\n6. Liver and kidney function: Alanine aminotransferase (ALT) \\\u003C 3 times the upper limit of the normal value (ULN), isolated elevation of aspartate aminotransferase (AST) (normal ALT) is acceptable; Serum creatinine ≤2×ULN;\n7. Eastern Cooperative Oncology Group (ECOG) Performance status score ≤2 points;\n8. Those with a history of malignant tumors must meet the following conditions:\n\n   Radical treatment has been achieved; The disease-free survival period complies with the protocol provisions (such as ≥1 year for basal cell carcinoma, ≥5 years for early solid tumors, ≥5 years for curable lymphoma, etc.); There is currently no evidence of recurrence. Those who do not meet the above conditions (such as CLL, advanced solid tumors, and active tumors) are not included.\n9. Voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Pregnant or lactating patients;\n2. Clinically confirmed SLE or other definite connective tissue diseases;\n3. Secondary AIHA secondary to lymphoproliferative diseases, other hematological malignancies, solid tumors, infections, and drugs;\n4. Cold-resistant type or hybrid type AIHA;\n5. Received before group enrollment:\n\n   Other immunosuppressants (such as rituximab, cyclosporine, etc., regardless of the duration); Glucocorticoid treatment for more than 2 weeks;\n6. Severe cardiac insufficiency (NYHA grade III\u002FIV, or LVEF \\\u003C 40%);\n7. Currently active malignant tumors, or previous tumors that do not meet the requirements of Article 8 of the inclusion criteria;\n8. Chronic active infections (active tuberculosis, active hepatitis B\u002FC, etc.);\n9. Severe immunodeficiency diseases, HIV infection (CD4⁺ \\\u003C 200\u002FμL), currently using other potent immunosuppressants, and using targeted biological agents within the last 3 months;\n10. Have a history of severe allergy to sirolimus, glucocorticoids or related excipients;\n11. Other circumstances where the researcher deems it inappropriate to participate.",{"count":135,"type":21},216,[137],"NA","This study is a prospective, multicenter, randomized controlled trial. A total of 216 adult patients with newly diagnosed wAIHA were planned to be included and randomly assigned in a 1:1 ratio to the experimental group (glucocorticoid combined with sirolimus) or the control group (glucocorticoid monotherapy). The initial dose of sirolimus in the experimental group was 1mg\u002Fd, adjusted according to the blood drug concentration. The target concentration was 4-12ng\u002FmL, and the treatment course was 6 months. Both groups of hormones were gradually reduced according to the standard protocol. All patients were followed up for 24 months, and the differences between the two groups at endpoints such as the hormone-free sustained response rate at the 12th month were compared.",[27],[141],"autoimmune hemolytic anemia","2026-04-04",{"date":144,"type":37},"2026-04-08",{"date":146,"type":21},"2026-04-01",{"date":148,"type":21},"2028-04-01",{"name":150,"class":44},"Chen Miao",{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":161,"phases":4,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":45},"100412026","national-longitudinal-cohort-of-hematological-diseases-100412026","NCT04645199","National Longitudinal Cohort of Hematological Diseases","National Longitudinal Cohort of Hematological Diseases (NICHE)","NICHE","Inclusion Criteria:\n\n* Patients who were diagnosed with acute myeloid leukemia, multiple myeloma, hemophilia, aplastic anemia, leukemia, myelodysplastic syndrome, lymphoma, bleeding disorders or received bone marrow transplantation in the investigating hospitals from January 1, 2020.\n\nExclusion Criteria:\n\n* Long-term follow-up information for patients is not available for any reason, such as not being available or having a serious concomitant disease.\n* Alcohol and drug addictions affect their ability to comply with study requirements.\n* According to the investigator, there are conditions that may endanger the patient's safety or affect his\u002Fher compliance.",{"count":160,"type":21},2300,"OBSERVATIONAL","Background 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. The purpose of this study is to analyze the incidence and risk factors of major blood diseases, the treatment methods, prognosis and medical expenses of these patients in China.\n\nMethod The study will include patients diagnosed with acute myeloid leukemia, multiple myeloma, hemophilia, aplastic anemia, leukemia, myelodysplastic syndrome, lymphoma, bleeding disorders, autoimmune hemolytic anemia, large granular lymphocyte leukemia, essential thrombocythemia, blood infection or received bone marrow transplantation in the investigating hospitals from January 1, 2020, and collect basic information, diagnostic and treatment information, prognosis information, as well as medical expense information from medical records. In its current form, the NICHE registry incorporates historical data (collected from 2000) and is systematically collecting prospective data in two phases with broadening reach, and prospectively follow-up to collect the prognosis information.",[164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180],"Multiple Myeloma","Acute Myeloid Leukemia","Hemophilia","Hemophilia A","Hemophilia B","Myelodysplastic Syndrome","MDS","Lymphoma","Leukemia","Aplastic Anemia","Bleeding Disorder","Bone Marrow Transplantation","Blood Disease Infection","Autoimmune Hemolytic Anemia, AIHA","Essential Thrombocythemia, ET","Large Granular Lymphocyte Leukemia, LGLL","Paroxysmal Nocturnal Hemoglobinuria, PNH","2026-02-09",{"date":183,"type":37},"2026-02-12",{"date":185,"type":37},"2020-12-01",{"date":187,"type":21},"2030-12-01",{"name":189,"class":44},"Institute of Hematology & Blood Diseases Hospital, China"]