[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569911":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":30,"responsibleParty":60,"collaborators":19,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":19,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":19,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":19,"overallStatus":49,"whyStopped":19,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},{"fullName":5,"class":6},"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TQB2029 injection","EXPERIMENTAL","TQB2029 injection, 28 days as a treatment cycle.",[13],"Drug: TQB2029 injection",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","TQB2029 for injection is a bispecific antibody targeting G Protein-Coupled Receptor, Class C, Group 5, Member D (GPRC5D) and Cluster of Differentiation 3 (CD3) . By recruiting and activating CD3 positive T cells, it induces T cells to kill malignant plasma cells expressing GPRC5D, thereby inhibiting the occurrence and development of tumors.",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Ting Niu, Doctor","CONTACT","028-85423046","tingniu@sina.com",{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},"Peng Liu, Doctor","021-60267405","Liu.peng@zs-hospital.sh.cn",[31,47],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Zhongshan Hospital of Fudan University","NOT_YET_RECRUITING","Shanghai","Shanghai Municipality","200032","China","CN",{"type":40,"coordinates":41},"Point",[42,43],121.45806,31.22222,{"lat":43,"lon":42},[46],{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":37,"countryCode":38,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"West China hospital, Sichuan university","RECRUITING","Chengdu","Sichuan","610000",{"type":40,"coordinates":54},[55,56],104.06667,30.66667,{"lat":56,"lon":55},[59],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},{"type":61,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100569911","phase-1-a-clinical-study-of-tqb2029-for-injection-in-subjects-with-multiple-myeloma-100569911",false,"NCT06700395","A Clinical Study of TQB2029 for Injection in Subjects With Multiple Myeloma","Phase I Clinical Study Evaluating the Tolerability and Pharmacokinetics of TQB2029 for Injection in Subjects With Multiple Myeloma","Inclusion Criteria:\n\n* Subjects who voluntarily join the study, sign the informed consent form, and have good compliance.\n* Aged from 18 to 75 years; Eastern Cooperative Oncology Group performance status score: 0-2; at least 12 weeks expected survival period.\n* Multiple myeloma with diagnostic records and meeting the International Myeloma Working Group (IMWG) diagnostic criteria\n* There are measurable lesions present\n* The function of main organs is normal.\n* Subjects need to adopt effective methods of contraception.\n\nExclusion Criteria:\n\n* Subjects who have taken Chinese patent medicines with anti-tumor indications in the drug instructions that National Medical Products Administration approved within 2 weeks before the first administration.\n* Subjects who received targeted therapy or immunotherapy within 3 weeks before the first medication\n* Subjects who is known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.\n* Subjects who has had or currently has other malignant tumors within the past 3 years prior to the first use of medication\n* Subjects who with unrelieved toxic reactions above Common Terminology Criteria for Adverse Events (CTC AE) grade 1 caused by any previous treatment\n* Subjects who have undergone major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the expected study treatment period within 4 weeks prior to the first use of medication\n* Subjects who have experienced arterial\u002Fvenous thrombotic event occurred within 6 months prior to the first administration\n* Subjects with a history of psychotropic drug abuse unable to quit or with mental disorders;\n* Subjects with any severe and\u002For uncontrolled disease\n* According to the judgment of the investigators, there are accompanying diseases that seriously endanger the safety of patients or affect the completion of the study.","ALL","18 Years","75 Years",{"count":73,"type":74},136,"ESTIMATED","INTERVENTIONAL",[77],"PHASE1","This is a study to evaluate the maximum tolerated dose (MTD), dose limiting toxicity (DLT), occurrence of all adverse events (AEs) and serious adverse events (SAEs), pharmacokinetic parameters, pharmacodynamic parameters, immunogenicity, and anti-tumor effects of TQB2029 for injection in Chinese adult subjects with multiple myeloma. The study is divided into Phase Ia and Ib, Phase Ia: dose escalation phase, to evaluate the safety and tolerability of TQB2029 for injection, and determining DLT and MTD; Phase Ib: Dose extension phase, to evaluate the effectiveness of TQB2029 for injection in subjects with multiple myeloma.",[80],"Multiple Myeloma","2024-12-04",{"date":83,"type":84},"2024-12-06","ACTUAL",{"date":86,"type":84},"2024-11-28",{"date":88,"type":74},"2028-03",{"name":90,"class":6},"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.",2]