[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599935":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":60,"collaborators":21,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":21,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":21,"enrollmentInfo":71,"targetDuration":21,"studyType":74,"phases":75,"briefSummary":78,"conditions":79,"keywords":21,"overallStatus":81,"whyStopped":21,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Genrix (Shanghai) Biopharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"GR1803 plus anti-CD38 monoclonal antibody","EXPERIMENTAL","Participants will be assigned to a combination of anti-CD38 monocloncal antibody plus GR1803 injection.",[13,14],"Drug: GR1803 injection","Drug: Anti-CD38 Monoclonal Antibody",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","GR1803 injection","Participants will receive GR1803 injection.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Anti-CD38 Monoclonal Antibody","Participants will receive anti-CD38 monoclonal antibody.",[9],[27],{"name":28,"role":29,"phone":30,"phoneExt":21,"email":31},"Cheng P He, Doctor of Meicine","CONTACT","86+18991232609","hepc_gcp@163.com",[33,49],{"facility":34,"status":21,"city":35,"state":21,"zip":21,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Shanghai Fourth People's Hospital Affiliated with Tongji University","Shanghai","China","CN",{"type":39,"coordinates":40},"Point",[41,42],121.45806,31.22222,{"lat":42,"lon":41},[45],{"name":46,"role":29,"phone":47,"phoneExt":21,"email":48},"Jun W Fu, Doctor of Medicine","86+13816052522","fuweijun2010@hotmail.com",{"facility":50,"status":21,"city":51,"state":21,"zip":21,"country":36,"countryCode":37,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"The First Affiliated Hospital of Xi'an Jiaotong University","Xi'an",{"type":39,"coordinates":53},[54,55],108.92861,34.25833,{"lat":55,"lon":54},[58],{"name":59,"role":29,"phone":30,"phoneExt":21,"email":31},"Cheng P He, Doctor of Medicine",{"type":61,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100599935","phase-1-a-study-of-gr1803-injection-in-combination-with-anti-cd38-monoclonal-antibody-for-the-treatment-of-participants-with-multiple-myeloma-100599935",false,"NCT07090954","A Study of GR1803 Injection in Combination With Anti-CD38 Monoclonal Antibody for the Treatment of Participants With Multiple Myeloma","An Open-Label, Multicenter, Phase Ib\u002FII Clinical Trial of GR1803 Injection in Combination With an Anti-CD38 Monoclonal Antibody Evaluating Safety, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy in Subjects With Relapsed\u002FRefractory Multiple Myeloma Previously Treated With at Least One Line of Therapy Including Lenalidomide and a Proteasome Inhibitor","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group performance status grade of 0, 1 or 2;\n* Diagnosis of multiple myeloma；have received at least one prior line of therapy including Lenalidomide and a proteasome inhibitor.\n* Able to understand and comply with the requirements of the clinical protocol, voluntarily participate in the clinical trial, and sign informed consent.\n\nExclusion Criteria:\n\n* Plasma cell leukemia , Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis.\n* Active central nervous system involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.\n* Prior treatment with any BCMA-targeted therapiy.\n* Active infecion.\n* Known allergies, hypersensitivity, or intolerance to the study drug or its excipients.","ALL","18 Years",{"count":72,"type":73},32,"ESTIMATED","INTERVENTIONAL",[76,77],"PHASE1","PHASE2","The purpose of this study is to identify recommended Phase 3 doses (RP3D) for treatment combination (GR1803 injection plus anti-CD38 monoclonal antibody) and to characterize the efficacy of RP3D for the treatment combination.",[80],"Multiple Myeloma","NOT_YET_RECRUITING","2025-07-21",{"date":84,"type":85},"2025-07-29","ACTUAL",{"date":87,"type":73},"2025-08-31",{"date":89,"type":73},"2030-01-31",{"name":5,"class":6},2]