[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549064":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":28,"studyPopulation":21,"armGroups":29,"interventions":35,"overallOfficials":21,"centralContacts":41,"locations":47,"responsibleParty":65,"collaborators":21,"id":67,"slug":21,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":21,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":21,"studyType":79,"phases":80,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":50,"whyStopped":21,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Shenzhen Geno-Immune Medical Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage of patients with treatment related adverse effects","The percentage of participants with treatment-related adverse events, as assessed by CTCAE v4.0","1 month",[14,18],{"measure":15,"description":16,"timeFrame":17},"Anti-tumor activity of the fourth generation multiple CAR-T cells after infusion","Anti-tumor activity of the fourth generation multiple CAR-T cells after infusion by measuring the CAR copies in the blood","1 year",{"measure":19,"description":20,"timeFrame":17},"Anti-tumor activity of fourth generation multiple CAR-T cells in patients with high-risk MM or plasmacytoma","Anti-tumor activity of fourth generation multiple CAR-T cells in patients with high-risk MM or plasmacytoma by examination of known tumor indicators",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":21,"primaryPurpose":25,"observationalModel":21,"timePerspective":21,"maskingInfo":26},"NA","SINGLE_GROUP","TREATMENT",{"masking":27,"maskingDescription":21,"whoMasked":21},"NONE","Multiple myeloma (MM) is the second most common malignant hematological cancer in the world, which begins with the malignant proliferation of plasma cells in bone marrow. It has been a difficult disease to treat, and most patients will eventually relapse, especially for those with high-risk genotypes. At present, the therapeutic drugs for MM include glucocorticoids, cytotoxic drugs, immunosuppressants, protease inhibitors, monoclonal antibodies and cell therapies. Among those, immunotherapy has been proven to be a revolutionary treatment with great potential of curing this disease. The frequently targeted MM antigens include CD38, CD138, CD19 and BCMA, and recently, GPRC5D.\n\nBCMA, the B cell maturation antigen, also known as CD269 or TNFRSF17, is a member of tumor necrosis factor receptor superfamily, which is highly expressed on the surface of plasma cells and partially expressed on plasma cell-like dendritic cells. It has been an ideal target for MM immunotherapy.\n\nGPRC5D, the G-protein-coupled receptor C57 subtype D and a seven-transmembrane protein, is highly expressed on the surface of plasma cells but not in other healthy cells, and thus it has become a potential target for the treatment of MM. The expression of GPRC5D is unrelated to BCMA, so the combination therapy targeting these antigens may bring a complementary and synergistic therapeutic outcome in patients.\n\nThis trial is aimed to test the safety and efficacy of combining these different CAR-T cells targeting BCMA and GPRC5D, and in combination with well-established therapeutics as a frontline treatment for the high-risk MM or plasmacytoma patients. Another goal of this study is to investigate the persistence and function of these CAR-T cells in the body.",[30],{"label":31,"type":32,"description":21,"interventionNames":33},"CAR-T cells to treat MM","EXPERIMENTAL",[34],"Biological: CAR-T cells",[36],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":21},"BIOLOGICAL","CAR-T cells","Infusion of multi-CAR-T cells",[31],[42],{"name":43,"role":44,"phone":45,"phoneExt":21,"email":46},"Lung-Ji Chang, ph.D","CONTACT","+86 0755-86573763","c@szgimi.org",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Shenzhen Geno-immune Medical Institute","RECRUITING","Shenzhen","Guangdong","518000","China","CN",{"type":57,"coordinates":58},"Point",[59,60],114.0683,22.54554,{"lat":60,"lon":59},[63],{"name":43,"role":44,"phone":45,"phoneExt":21,"email":64},"c@szgimi.com",{"type":66,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100549064",false,"NCT06429150","Frontline Combination CAR-T Cell Therapy for Multiple Myeloma or Plasmacytoma","Frontline Management of High-Risk Multiple Myeloma or Plasmacytoma With BCMA and GPRC5D Combination CAR-T Cell Therapy","Inclusion Criteria:\n\n* Male and female subjects with multiple myeloma or plasmacytoma\n* Strictly complete remission (sCR) is a treatment goal\n* Expected survival \\> 12 weeks\n* After prior auto-SCT is eligible regardless of other prior therapies\n* Adequate venous access for apheresis, and no other contraindications for leukapheresis\n* Voluntary informed consent is given and commitment to continued follow-up\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Uncontrolled active infection\n* Active HIV, hepatitis B or hepatitis C infection\n* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.\n* Any medical conditions that may preclude participation","ALL","18 Years","80 Years",{"count":77,"type":78},20,"ESTIMATED","INTERVENTIONAL",[81,82],"PHASE1","PHASE2","The aim of this clinical trial is to assess the feasibility, safety, and efficacy of CAR-T cell therapy targeting multiple cancer cell antigens in high-risk multiple myeloma or plasmacytoma as part of a frontline treatment regimen for patients. Another goal of the study is to learn more about the persistence and function of these CAR-T cells in the body.",[85,86],"Multiple Myeloma","Plasmacytoma",[88,89,90,91],"multiple myeloma","chimeric antigen receptor","BCMA","GPRC5D","2026-06-18",{"date":94,"type":95},"2026-06-23","ACTUAL",{"date":97,"type":95},"2024-05-11",{"date":99,"type":78},"2027-12-31",{"name":5,"class":6},1]