[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517225":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":49,"collaborators":20,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":20,"enrollmentInfo":61,"targetDuration":20,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":20,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention（Anti-CD38 antibody）","EXPERIMENTAL","10 enrolled subjects : once a week x 8 doses",[13],"Drug: Anti-CD38 antibody Injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Anti-CD38 antibody Injection","intravenous Anti-CD38 antibody administration\n\nThis study adopts a prospective, single arm, open design method. Ten subjects were enrolled in the study and were treated with Anti-CD38 antibody (16mg\u002Fkg\u002Fw) for 8 weeks.\n\nThe first stage is the main research stage (d1-w8), which is the core treatment period. The subjects will receive intravenous infusion of 16mg\u002Fkg Anti-CD38 antibody once a week for 8 weeks to observe the safety and efficacy during treatment.\n\nThe second stage (w9-w24) is the stage of withdrawal from the visit, mainly to observe the safety and continuous efficacy of Anti-CD38 antibody after treatment.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Lei Zhang, M.D","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Ting Sun, M.D","CONTACT","+86 022-23909009","sunting@ihcams.ac.cn",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Chinese Academy of Medical Science and Blood Disease Hospital","RECRUITING","Tianjin","Tianjin Municipality","300020","China","CN",{"type":41,"coordinates":42},"Point",[43,44],117.17667,39.14222,{"lat":44,"lon":43},[47],{"name":27,"role":28,"phone":48,"phoneExt":20,"email":30},"+86-22-23909009",{"type":50,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100517225","phase-2-anti-cd38-antibody-treating-evans-syndrome-100517225",false,"NCT06014775","Anti-CD38 Antibody Treating Evans Syndrome","A Prospective, One-arm and Open Clinical Study to Assess Safety and Efficacy of Anti-CD38 Antibody in the Treatment of Evans Syndrome","2023-D-ES","Inclusion Criteria:\n\n* Male or female aged ≥18 years.\n* Prior to enrollment, a clinical diagnosis of primary Evans syndrome was made.\n* Platelet count \\\u003C 30×10\\^9\u002FL or Hb \\\u003C 100g\u002FL or symptomatic anemia within 48 hours before the first administration of study drug;\n* Failure to achieve response or relapse after corticosteroid therapy, and at least one second-line therapy or those who cannot chose other second-line therapy;\n* If receiving emergency care for ES, treatment should be stopped \\>2 weeks before first dose.\n* DAT positive (IgG+, with or without C3+).\n* The patient need to be in the state of active hemolysis.\n* With normal hepatic and renal functions.\n* ECOG performance status ≤2.\n* Cardiac function: New York Heart Association functional class ≤2.\n* For patients receiving maintenance treatment, corticosteroids must have a stable dose at least 2 weeks before the first administration, TPO receptor agonists and azathioprine, danazol, cyclosporin A, tacrolimus, sirolimus, etc. must be stopped at least 4 weeks before the first administration; The end of anti-CD20 antibody treatment was\\>6 months.The end of alkylating agent treatment was\\>2 months.\n* Understand the study procedures and voluntarily sign the informed consent form in person.\n\nExclusion Criteria:\n\n* Secondary Evans syndrome. Received any treatment of anti-CD38 antibody drug\n* Uncontrollable primary diseases of important organs, such as malignant tumors, liver failure, heart failure, renal failure and other diseases;\n* HIV positive;\n* Accompanied by uncontrollable active infection, including hepatitis B, hepatitis C, cytomegalovirus, EB virus and syphilis positive;\n* Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc.;\n* At present, there are heart diseases, arrhythmias that need treatment or hypertension that researchers judge is poorly controlled;\n* Patients with thrombotic diseases such as pulmonary embolism, thrombosis and atherosclerosis;\n* Those who have received allogeneic stem cell transplantation or organ transplantation in the past;\n* Patients with mental disorders who cannot normally obtain informed consent and conduct trials and follow-up;\n* Patients whose toxic symptoms caused by pre-trial treatment have not disappeared;\n* Other serious diseases that may limit the subject's participation in this test (such as diabetes; Severe cardiac insufficiency; Myocardial obstruction or unstable arrhythmia or unstable angina pectoris in recent 6 months; Gastric ulcer, etc.);\n* Patients with septicemia or other irregular severe bleeding;\n* Patients taking antiplatelet drugs at the same time;\n* Pregnant women, suspected pregnancies (positive pregnancy test for human chorionic gonadotropin in urine at screening) and lactating patients.","ALL","18 Years",{"count":62,"type":63},10,"ESTIMATED","INTERVENTIONAL",[66],"PHASE2","A single-center, open-label, off-label use investigator-initiated clinical study with safety run-in to explore the clinical activity and safety of Anti-CD38 Antibody in adult ES patients who have not responded adequately or relapsed after first-line treatment and at least one second-line therapy including immunosuppressive agents, Anti-CD20 Antibody and\u002For TPO-RA, or those in whom no other second-line treatment options are suitable.",[69,70],"Evan Syndrome","Treatment","2025-02-20",{"date":73,"type":74},"2025-02-21","ACTUAL",{"date":76,"type":74},"2023-12-01",{"date":78,"type":63},"2025-08",{"name":5,"class":6},1]