[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639937":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":20,"responsibleParty":21,"collaborators":20,"id":25,"slug":26,"hasResults":27,"nctId":28,"briefTitle":29,"officialTitle":30,"acronym":20,"eligibilityCriteria":31,"healthyVolunteers":27,"sex":32,"minAge":33,"maxAge":34,"enrollmentInfo":35,"targetDuration":20,"studyType":38,"phases":39,"briefSummary":41,"conditions":42,"keywords":20,"overallStatus":47,"whyStopped":20,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":20},{"fullName":5,"class":6},"Tianjin First Central Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Zuberitamab-Orelabrutinib combination therapy","EXPERIMENTAL","This study is designed as a non-randomized, single-arm, open-label clinical trial. Patients with refractory immune-related cytopenia, including immune thrombocytopenia (ITP) and autoimmune hemolytic anemia (AIHA), are intended for enrollment. The treatment regimen and schedule are as follows: anti-CD20 monoclonal antibody (Zuberitamab): 100 mg per dose on Days 1, 8, 15, and 22; BTK inhibitor (Orelabrutinib): 50 mg once daily (qd) from Day 1 to Day 90.",[13],"Drug: Anti-CD20 monoclonal antibody and the BTK inhibitor",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Anti-CD20 monoclonal antibody and the BTK inhibitor","This is a novel combination regimen of anti-CD20 monoclonal antibody plus BTKi, specifically designed for patients with refractory immune-related cytopenia.",[9],null,{"type":22,"investigatorFullName":23,"investigatorTitle":24,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Qi deng","Chief Physician","100639937","phase-1-cd20-monoclonal-antibody-combined-with-btk-inhibitor-for-the-treatment-of-refractory-immune-related-cytopenia-100639937",false,"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.","ALL","18 Years","80 Years",{"count":36,"type":37},30,"ESTIMATED","INTERVENTIONAL",[40],"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).",[43,44,45,46],"Anti-CD20 Monoclonal Antibody","BTK Inhibitors","Immune Thrombocytopenia (ITP)","Autoimmune Hemolytic Anemia (AIHA)","NOT_YET_RECRUITING","2026-05-19",{"date":50,"type":51},"2026-05-22","ACTUAL",{"date":53,"type":37},"2026-06-01",{"date":55,"type":37},"2028-05-31",{"name":23,"class":6}]