[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614530":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":30,"locations":20,"responsibleParty":39,"collaborators":20,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":20,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":20,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":64,"overallStatus":69,"whyStopped":20,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":75,"leadSponsor":77,"locationsCount":20},{"fullName":5,"class":6},"Xuzhou Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"68Ga-NOTA-BCMA","EXPERIMENTAL","Eligible subjects enrolled in the study will receive a predetermined dose of the 68Ga-NOTA-BCMA radiopharmaceutical preparation as part of the investigational imaging protocol.",[13,14],"Other: BCMA-Targeting CAR-T Cell Therapy","Device: PET\u002FCT Imaging",[16,21],{"type":6,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BCMA-Targeting CAR-T Cell Therapy","Patient T-cells are harvested and genetically engineered to express chimeric antigen receptors (CARs) targeting B-cell maturation antigen (BCMA). These modified CAR-T cells specifically recognize and eliminate multiple myeloma cells expressing BCMA. Following reinfusion, the CAR-T cells undergo antigen-stimulated proliferation, establishing sustained antitumor immune activity.",[9],null,{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":20},"DEVICE","PET\u002FCT Imaging","A low-dose PET\u002FCT scan will be performed 60 minutes post-administration of the agent. Low-dose CT is only utilized for anatomic localization and PET attenuation correction, and the radiation dose involved is substantially lower than that of conventional CT.",[9],[27],{"name":28,"affiliation":5,"role":29},"Xueyan Zhou, M.D., Ph.D.","PRINCIPAL_INVESTIGATOR",[31,35],{"name":28,"role":32,"phone":33,"phoneExt":20,"email":34},"CONTACT","15105200571","zxy851107@xzhmu.edu.cn",{"name":36,"role":32,"phone":37,"phoneExt":20,"email":38},"Jiang Cao","13852432263","zimu05067@163.com",{"type":29,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Kai Lin Xu，MD","Chief physician","100614530","early-phase-1-car-t-cell-efficacy-with-molecular-imaging-in-multiple-myeloma-100614530",false,"NCT07280793","CAR-T Cell Efficacy With Molecular Imaging in Multiple Myeloma","Visualizing CAR-T Cell Therapy in Multiple Myeloma Using a BCMA-Targeted PET Probe","Inclusion Criteria:\n\n* \\*\\*Inclusion Criteria\\*\\*\n\n  1. Subjects must voluntarily sign the informed consent form and be able to complete the trial per the protocol requirements.\n  2. Age 18 years or older, regardless of gender.\n  3. Diagnosed with multiple myeloma and scheduled to receive anti-BCMA CAR-T cell therapy.\n  4. ECOG performance status of 0-2; with a life expectancy of not less than 3 months.\n  5. Female subjects of childbearing potential must have a negative serum pregnancy test prior to enrollment.\n  6. For female subjects of childbearing potential or male subjects with partners of childbearing potential, agreement to remain abstinent or use one or more forms of contraception with a failure rate of \\\u003C1% per year during the study period and for at least one year after the study completion.\n\nExclusion Criteria:\n\n* \\*\\*Exclusion Criteria\\*\\*\n\n  1. Participation in another interventional clinical trial, concurrently or within 28 days prior to the first dose in this study. Participation in non-interventional trials is permitted.\n  2. History of hypersensitivity to any component of the imaging agent or antibodies, or a known allergic predisposition.\n  3. Inability to undergo PET\u002FCT imaging, such as due to claustrophobia or emotional instability.\n  4. Current use of anticoagulant therapy or anticipated requirement for such therapy during the study period.\n  5. Known allergic or hypersensitivity reactions to biological products or any excipient of the 68Ga-NOTA-BCMA molecular probe.\n  6. Active hepatitis B or C infection, or seropositivity for human immunodeficiency virus (HIV) antibody or Treponema pallidum antibody.\n  7. Pregnancy, lactation, or intention to become pregnant during the trial period.\n  8. Any other condition deemed by the investigator to render the subject unsuitable for trial participation.","ALL","18 Years","75 Years",{"count":53,"type":54},10,"ESTIMATED","INTERVENTIONAL",[57],"EARLY_PHASE1","⁶⁸Ga-NOTA-BCMA is a novel, targeted PET tracer under clinical investigation. It is designed to provide a non-invasive method for monitoring the biodistribution and persistence of BCMA CAR-T cells in patients. Preclinical data robustly support its specific binding, favorable pharmacokinetics, and excellent safety profile, warranting its advancement into clinical studies.",[60,61,62,63],"Non-invasive CAR-T Cell Monitoring","BCMA-targeted PET Imaging","CAR-T Cell Biodistribution and Persistence","GMP-compliant Radiopharmaceutical Preparation",[65,66,67,68],"⁶⁸Ga-NOTA-BCMA","BCMA CAR-T cell imaging","BCMA PET tracer","Radiolabeled BCMA peptide","NOT_YET_RECRUITING","2025-12-16",{"date":72,"type":73},"2025-12-17","ACTUAL",{"date":72,"type":54},{"date":76,"type":54},"2027-12-30",{"name":5,"class":6}]