[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-andor-refractory-multiple-myeloma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-andor-refractory-multiple-myeloma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100527860","phase-1-a-study-to-assess-bms-986453-in-participants-with-relapsed-andor-refractory-multiple-myeloma-100527860",false,"NCT06153251","A Study to Assess BMS-986453 in Participants With Relapsed and\u002For Refractory Multiple Myeloma","A Phase 1, Open-Label, Dose-Finding Study of BMS-986453, Dual Targeting BCMAxGPRC5D Chimeric Antigen Receptor T Cells, in Participants With Relapsed and\u002For Refractory Multiple Myeloma","Inclusion Criteria:\n\n* Participants must have a diagnosis of multiple myeloma with relapsed and\u002For refractory disease.\n* Participants must have confirmed progressive disease on or within 12 months (measured from the last dose) of completing treatment with the last anti-myeloma treatment regimen before study entry.\n* Participants in Part A and Part B Cohort 1 and in Part B Cohort 2 must have relapsed\u002Frefractory multiple myeloma and received previous antimyeloma therapy, including a proteasome inhibitor and an immunomodulatory agent.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participants must have adequate organ function.\n\nExclusion Criteria:\n\n* Participants must not have any known active or history of central nervous system (CNS) involvement of multiple myeloma.\n* Participants must not have active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis.\n* Participants must not have a history or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, or cerebellar disease, or presence of clinically active psychosis.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.","ALL","18 Years",{"count":19,"type":20},187,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The purpose of this study is to assess BMS-986453 in participants with relapsed and\u002For refractory multiple myeloma (RRMM).",[26],"Relapsed and\u002For Refractory Multiple Myeloma",[28,29,30,31,32,33,34,35],"Dual Targeting","BCMAxGPRC5D","GPRC5DxBCMA","BMS-986453","CAR T","CART","Multiple Myeloma","Relapsed and\u002For Refractory","RECRUITING","2026-03-16",{"date":39,"type":40},"2026-03-18","ACTUAL",{"date":42,"type":40},"2024-01-23",{"date":44,"type":20},"2030-05-02",{"name":46,"class":47},"Juno Therapeutics, Inc., a Bristol-Myers Squibb Company","INDUSTRY",19,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100530124","phase-1-oricar-017-chimeric-antigen-receptor-car-modified-t-cells-for-the-treatment-of-rrmm-100530124","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.","75 Years",{"count":58,"type":20},83,[23,60],"PHASE2","An open label, dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of OriCAR-017 in R\u002FRMM",[26],"2024-05-30",{"date":65,"type":40},"2024-05-31",{"date":67,"type":40},"2023-10-26",{"date":69,"type":20},"2028-08-31",{"name":71,"class":47},"OriCell Therapeutics Co., Ltd.",5]