[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584393":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":29,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":20,"eligibilityCriteria":40,"healthyVolunteers":36,"sex":41,"minAge":42,"maxAge":20,"enrollmentInfo":43,"targetDuration":20,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":52,"overallStatus":55,"whyStopped":20,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":20},{"fullName":5,"class":6},"First Affiliated Hospital of Wenzhou Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"LCAR-M61SQ","EXPERIMENTAL","Each subject will be given a single-dose LCAR-M61SQ cells infusion at each dose level",[13],"Biological: Cell injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Cell injection","LCAR-M61SQ cells intravenous infusion; Prior to infusion of the LCAR-M61SQ cell, Subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Songfu Jiang, MD","CONTACT","15305770033","jiangsongfu@189.cn",{"type":28,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[30,32],{"name":31,"class":6},"Beijing Boren Hospital",{"name":33,"class":6},"First People's Hospital of Hangzhou","100584393","lcar-m61sq-in-treatment-of-relapsedrefractory-multiple-myeloma-100584393",false,"NCT06888752","LCAR-M61SQ in Treatment of Relapsed\u002FRefractory Multiple Myeloma","A Clinical Study to Evaluate the Safety, Tolerance and Efficacy of LCAR-M61SQ Cell in Patients with Relapsed\u002FRefractory Multiple Myeloma.","Inclusion Criteria:\n\n* Subjects voluntarily participate in clinical research;\n* Age ≥18 years old;\n* Eastern Cooperative Oncology Group (ECOG) score 0-2;\n* Examination evidence of initial diagnosis of MM according to IMWG diagnostic criteria;\n* Measurable lesions were present;\n* Subjects have received at least three previous lines of multiple myeloma therapy, each with at least one complete therapy cycle, unless the best response to the therapeutic regimen was documented as disease progression (PD confirmed according to IMWG criteria);\n* Expected survival ≥3 months;\n* Clinical laboratory values in the screening period meet criteria;\n\nExclusion Criteria:\n\n* Received previous therapy targeting GPRC5D targets;\n* Prior antineoplastic therapy and meet exclusion criteria (before apheresis);\n* Subjects had Waldenstrom macroglobulinemia, POEMS syndrome, or primary AL amyloidosis at the time of screening.\n* Subjects who were positive for any of HBsAg, HBV DNA, HCV-Ab, HCV RNA, and HIV-Ab;\n* Life-threatening allergic reactions, hypersensitivity reactions, or intolerance to CAR-T cell formulations or their excipients, including DMSO, are known.\n* Serious underlying diseases were present;\n* Female subjects who were pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving study treatment.\n* Also enrolled in other clinical studies.","ALL","18 Years",{"count":44,"type":45},35,"ESTIMATED","INTERVENTIONAL",[48],"NA","A prospective, open-label dose-exploration and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-M61SQ in patients with relapsed\u002Frefractory multiple myeloma.",[51],"Relapsed\u002FRefractory Multiple Myeloma",[53,54],"multiple myeloma","Relapsed\u002FRefractory multiple myeloma","NOT_YET_RECRUITING","2025-03-17",{"date":58,"type":59},"2025-03-21","ACTUAL",{"date":61,"type":45},"2025-03-20",{"date":63,"type":45},"2030-12-30",{"name":5,"class":6}]