[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530124":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":90,"collaborators":20,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":20,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":20,"studyType":105,"phases":106,"briefSummary":109,"conditions":110,"keywords":20,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"OriCell Therapeutics Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"OriCAR-017 ( GPCRC5D-directed chimeric antigen receptor modified T cells )","EXPERIMENTAL","Phase I (Dose-Escalation) The subjects enrolled will be sequentially assigned to the corresponding dose level to determin the RP2D. The dose-escalation part of the study will adopt the the standard 3+3 design, wherein 3 dose levels are planned to be evaluated.\n\nPhase I (Dose-Expansion) After determining the RP2D, one of the dose levels will be selected for further evaluation during the dose-expansion part. Up to 10 to 15 additional subjects who are diagnosed with relapsed\u002Frefractory MM will be enrolled to further explore the anti-tumor activity of Ori-CAR-017.\n\nPhase II The Phase II part of the study will be initiated at the RP2D of OriCAR-017 which will be selected based on the clinical data obtained during the Phase I part of the study.",[13],"Biological: OriCAR-017",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","OriCAR-017","GPCRC5D-directed chimeric antigen receptor modified T cells",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"HE Huang, MD","CONTACT","0571-88208277","hehuangyu@126.com",[28,45,57,68,79],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"The First Affiliated Hospital College of Medicine Zhejiang University","RECRUITING","Hangzhou","Zhejiang","310003","China","CN",{"type":37,"coordinates":38},"Point",[39,40],120.16142,30.29365,{"lat":40,"lon":39},[43],{"name":44,"role":24,"phone":20,"phoneExt":20,"email":26},"HE Huang",{"facility":46,"status":47,"city":48,"state":20,"zip":20,"country":34,"countryCode":35,"cosmosGeoPoint":49,"geoPoint":53,"contacts":54},"Beijing GoBroad Hospital","NOT_YET_RECRUITING","Beijing",{"type":37,"coordinates":50},[51,52],116.39723,39.9075,{"lat":52,"lon":51},[55],{"name":56,"role":24,"phone":20,"phoneExt":20,"email":20},"Kai Hu",{"facility":58,"status":47,"city":59,"state":20,"zip":20,"country":34,"countryCode":35,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"The First Affiliated Hospital with Nanjing Medical University","Nanjing",{"type":37,"coordinates":61},[62,63],118.77778,32.06167,{"lat":63,"lon":62},[66],{"name":67,"role":24,"phone":20,"phoneExt":20,"email":20},"Jianyong Li",{"facility":69,"status":47,"city":70,"state":20,"zip":20,"country":34,"countryCode":35,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Tongji Hospital of Tongji University","Shanghai",{"type":37,"coordinates":72},[73,74],121.45806,31.22222,{"lat":74,"lon":73},[77],{"name":78,"role":24,"phone":20,"phoneExt":20,"email":20},"Aibin Liang",{"facility":80,"status":30,"city":81,"state":20,"zip":20,"country":34,"countryCode":35,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Union Hospital Tongji Medical College Huazhong University of Science and Technology","Wuhan",{"type":37,"coordinates":83},[84,85],114.26667,30.58333,{"lat":85,"lon":84},[88],{"name":89,"role":24,"phone":20,"phoneExt":20,"email":20},"Heng Mei",{"type":91,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100530124","phase-1-oricar-017-chimeric-antigen-receptor-car-modified-t-cells-for-the-treatment-of-rrmm-100530124",false,"NCT06182696","OriCAR-017 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of R\u002FRMM","An Open Label,Multi-center Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Autologous T Cell Injection Targeting GPRC5D OriCAR-017 in Patients With Relapsed and\u002For Refractory Multiplemyeloma","Main Inclusion Criteria:\n\n* Diagnosis of R\u002FRMM according to the IMWG criteria;\n* Expected survival period is \\>12 weeks;\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or 2 at the time of ICF signature;\n* The expression of GPRC5D in bone marrow plasma cells membrane is more than 20% by flow cytometry and\u002For immunohistochemistry, multiple myeloma with measurable lesions, and at least one of the following criteria must be met:\n\n  1. Serum M protein \\>5 g\u002FL;\n  2. Urine M protein level \\>200 mg\u002F24 hour;\n  3. Serum free light chain (sFLC) \\>100 mg\u002FL and K\u002Fλ FLC ratio is abnormal;\n  4. Primitive immature or monoclonal plasma cells \\>5% by bone marrow cytology or flow cytometry.\n* Subjects who had received at least 3 prior lines of therapy including (but not limited to) immunomodulatory drugs (IMiDs), proteasome inhibitors, anti-CD38 monoclonal antibodies, etc., but have failed treatment, including those who have experienced relapse (within 12 months), refractory or intolerant to the last line treatment regimen.\n\nMain Exclusion Criteria:\n\n* Smoldering myeloma (asymptomatic)\n* Multiple myeloma with only extramedullary lesions;\n* Plasma cell leukemia;\n* Concurrent amyloidosis;\n* Central nervous system metastasis, leptomeningeal disease or metastatic central compression;\n* HBsAg or HbcAb is positive, and the quantitative detection of hepatitis B virus (HBV) DNA in peripheral blood is more than 100 copies\u002FL; hepatitis C virus (HCV) antibody and HCV RNA in peripheral blood is positive; human immunodeficiency virus (HIV) antibody positive; syphilis antibody is positive at Screening; Cytomegalovirus DNA test is positive;\n* Had hypersensitivity or intolerance to any drug\u002Fexcipient (including conditioning chemotherapy) used in this study;\n* Previously received treatment targeting GPRC5D, including but not limited to antibodies, ADC, or CAR-T;\n* Subjects who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks of Screening Visit or who plan to undergo ASCT during the study;\n* Any uncontrolled active infection within 4 weeks prior to ICF signing or leukapheresis requires parenteral antibiotic, antiviral, or antifungal treatment\n* Major surgery within 28 days prior to Screening Visit with the exception of a biopsy and an insertion of a central venous catheter or during the study;\n* Subjects who received allogeneic stem cell therapy;\n* Subjects complications or other conditions evaluated by investigators may affect compliance with the protocol or make them unsuitable to participate in this study;\n* Pregnant or breastfeeding.","ALL","18 Years","75 Years",{"count":103,"type":104},83,"ESTIMATED","INTERVENTIONAL",[107,108],"PHASE1","PHASE2","An open label, dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of OriCAR-017 in R\u002FRMM",[111],"Relapsed and\u002For Refractory Multiple Myeloma","2024-05-30",{"date":114,"type":115},"2024-05-31","ACTUAL",{"date":117,"type":115},"2023-10-26",{"date":119,"type":104},"2028-08-31",{"name":5,"class":6},5]