[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576940":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":43,"responsibleParty":58,"collaborators":11,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":11,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":11,"enrollmentInfo":69,"targetDuration":11,"studyType":72,"phases":73,"briefSummary":76,"conditions":77,"keywords":11,"overallStatus":79,"whyStopped":11,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Keymed Biosciences Co.Ltd","INDUSTRY",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"CM313(SC)(low dose group)","EXPERIMENTAL",null,[13],"Biological: CM313(SC) injection",{"label":15,"type":10,"description":11,"interventionNames":16},"CM313(SC)(medium dose group)",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"CM313(SC)(high dose group)",[13],[21,26,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"BIOLOGICAL","CM313(SC) injection","Phase IB: CM313(SC) administered at low dose according to the protocol. Phase II: CM313(SC) administered at different doses based on Phase IB's results.",[9],{"type":22,"name":23,"description":27,"armGroupLabels":28,"otherNames":11},"Phase IB: CM313(SC) administered at medium dose according to the protocol. Phase II: CM313(SC) administered at different doses based on Phase IB's results.",[15],{"type":22,"name":23,"description":30,"armGroupLabels":31,"otherNames":11},"Phase IB: CM313(SC) administered at high dose according to the protocol. Phase II: CM313(SC) administered at different doses based on Phase IB's results.",[18],[33],{"name":34,"affiliation":35,"role":36},"Jun Shi","Institute of Hematology & Blood Diseases Hospital, China","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":11,"email":42},"Qian Jia","CONTACT","028-88610620","qianjia@keymedbio.com",[44],{"facility":45,"status":11,"city":46,"state":47,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Institute of Hematology & Blood Diseases Hospital","Tianjin","Tianjin Municipality","China","CN",{"type":51,"coordinates":52},"Point",[53,54],117.17667,39.14222,{"lat":54,"lon":53},[57],{"name":34,"role":40,"phone":11,"phoneExt":11,"email":11},{"type":59,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100576940","phase-1-study-of-cm313sc-injection-in-subjects-with-relapsedrefractory-aplastic-anemia-100576940",false,"NCT06791824","Study of CM313(SC) Injection in Subjects With Relapsed\u002FRefractory Aplastic Anemia","A Phase IB\u002FII Clinical Study to Assess the Safety, Tolerability and Preliminary Efficacy of CM313(SC) Injection in Subjects With Relapsed\u002FRefractory Aplastic Anemia","Inclusion Criteria:\n\n1. Diagnosis of idiopathic aplastic anemia.\n2. Patients must meet the requirements of relapsed\u002Frefractory aplastic anemia defined in the protocol.\n3. Male or female, age≥18 years.\n4. The Eastern Cooperative Oncology Group (ECOG) physical status score ≤2.\n5. Willing and able to comply with the requirements for this study and written informed consent.\n\nExclusion Criteria:\n\n1. The inherited bone marrow failure syndromes.\n2. Previously treated with the anti-CD38 monoclonal antibody.\n3. Have an allergy to humanized monoclonal antibody or any part of CM313.\n4. Pregnant or breastfeeding females, or females planning to become pregnant during the study.\n5. Any condition considered to be ineligible for the study by the investigator.","ALL","18 Years",{"count":70,"type":71},125,"ESTIMATED","INTERVENTIONAL",[74,75],"PHASE1","PHASE2","This is a randomized, open-label, phase IB\u002FII clinical study to evaluate the safety, tolerability and preliminary efficacy of CM313(SC) injection in patients with relapsed\u002Frefractory aplastic anemia",[78],"Aplastic Anemia","NOT_YET_RECRUITING","2025-02-14",{"date":82,"type":83},"2025-02-18","ACTUAL",{"date":85,"type":71},"2025-03",{"date":87,"type":71},"2027-12",{"name":5,"class":6},1]