[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657071":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":46,"studyPopulation":47,"armGroups":48,"interventions":52,"overallOfficials":44,"centralContacts":56,"locations":62,"responsibleParty":78,"collaborators":82,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":44,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":44,"maxAge":44,"enrollmentInfo":99,"targetDuration":44,"studyType":102,"phases":44,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":109,"whyStopped":44,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"RenJi Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":37},[9,13],{"measure":10,"description":11,"timeFrame":12},"Incidence of specific Aes","Specific AEs include:\n\n* New malignancies (defined as new primary malignancies or recurrence of pre-existing malignancies other than MM);\n\n  * New onset of grade ≥3 infections;\n\n    * New onset or worsening of pre-existing neurological disorders; ④ New onset or worsening of pre-existing rheumatism\u002Fother autoimmune diseases; ⑤ New onset of grade ≥3 hematologic toxicity related to GC012F Injection.","15 years from GC012F Injection administration",{"measure":14,"description":15,"timeFrame":16},"Adverse Events (AEs)","Incidence of AEs related to GC012F Injection","15 years from the administration of GC012F Injection",[18,22,25,28,31,34],{"measure":19,"description":20,"timeFrame":21},"Overall Survival (OS)","The time from the initiation of GC012F Injection treatment to death (from any cause).","Long-term follow-up from GC012F Injection administration to 15 years post-dose,",{"measure":23,"description":24,"timeFrame":21},"Progression-free Survival (PFS)","The time from the initiation of GC012F Injection treatment to the first occurrence of disease progression or death from any cause",{"measure":26,"description":27,"timeFrame":21},"Duration of Response (DoR)","The time from the first evaluation of sCR, CR, VGPR or PR for the tumor to the first evaluation of disease progression or death from any cause.",{"measure":29,"description":30,"timeFrame":21},"Objective Response Rate (ORR)","According to the 2016 IMWG response evaluation criteria: ORR (sCR + CR + VGPR + PR), ≥VGPR rate (VGPR + CR + sCR), ≥CR rate (CR + sCR);",{"measure":32,"description":33,"timeFrame":21},"Replication-competent lentivirus (RCL) in peripheral blood","Detection of RCL in Peripheral Blood by Real-time Fluorescent Quantitative PCR (q-PCR)",{"measure":35,"description":36,"timeFrame":21},"Minimal residual disease (MRD)","Minimal residual disease (MRD) negativity rate, MRD-negative CR rate, and duration of MRD negativity;",[38,41],{"measure":39,"description":40,"timeFrame":21},"Last detectable time point (Tlast)","Cytokinetics (CK) profile of GC012F CAR-T celltherapy",{"measure":42,"description":40,"timeFrame":21},"Last quantifiable concentration (Clast)",{"allocation":44,"interventionModel":44,"interventionModelDescription":44,"primaryPurpose":44,"observationalModel":45,"timePerspective":6,"maskingInfo":44},null,"CASE_ONLY","This is an open-label, multicenter, observational study (non-interventional study) to evaluate the long-term safety, efficacy, and in vivo pharmacokinetic persistence of CAR-T cells in subjects treated with GC012F Injection. The study population consists of patients with multiple myeloma who previously received GC012F Injection in an investigator-initiated trial. Subjects enrolled in this study must have completed the efficacy and safety follow-up of the main study or withdrawn early from the main study.\n\nNo additional study drug will be administered in this study (i.e., no further use of the study drug). If the main study in which the subject previously participated allowed lenalidomide maintenance therapy after GC012F Injection treatment, the subject may continue to receive lenalidomide maintenance therapy after being enrolled in this study, which will not be counted as receiving another antitumor therapy. For 15 years from the time the subject received GC012F Injection infusion, data, including specific adverse events (AEs) \\[including new malignancies, new onset of grade ≥3 infections, new onset or worsening of pre-existing neurological disorders, new onset or worsening of pre-existing rheumatism\u002Fother autoimmune diseases, and new onset of grade ≥3 hematologic toxicity related to GC012F Injection\\], AEs related to GC012F Injection, overall survival (OS), progression-free survival (PFS), duration of response (DOR), objective response rate (ORR), replication-competent lentivirus (RCL), and CAR gene insertion site testing, will be collected to evaluate the long-term safety, tolerability, efficacy, and in vivo pharmacokinetic persistence of CAR-T cells.","Previously treated with GC012F Injection",[49],{"label":47,"type":44,"description":44,"interventionNames":50},[51],"Other: No Intervention: Observational Cohort",[53],{"type":6,"name":54,"description":54,"armGroupLabels":55,"otherNames":44},"No Intervention: Observational Cohort",[47],[57],{"name":58,"role":59,"phone":60,"phoneExt":44,"email":61},"Juan Du","CONTACT","15800706091","dujuangcp@outlook.com",[63],{"facility":64,"status":44,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Renji Hospital, Shanghai Jiaotong University School of Medicine","Shanghai","Shanghai Municipality","200000","China","CN",{"type":71,"coordinates":72},"Point",[73,74],121.45806,31.22222,{"lat":74,"lon":73},[77],{"name":58,"role":59,"phone":60,"phoneExt":44,"email":61},{"type":79,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"PRINCIPAL_INVESTIGATOR","Juan Du（juandu）","PhD",[83,86,89],{"name":84,"class":85},"Gracell Biotechnologies (Shanghai) Co., Ltd.","INDUSTRY",{"name":87,"class":88},"AstraZeneca Global R&D (China) Co., Ltd.","UNKNOWN",{"name":90,"class":88},"AstraZeneca Global R&D (Beijing) Co., Ltd.","100657071","long-term-follow-up-study-in-subjects-with-multiple-myeloma-previously-treated-with-gc012f-injection-100657071",false,"NCT07833046","Long-term Follow-up Study in Subjects With Multiple Myeloma Previously Treated With GC012F Injection","Long-term Follow-up Study to Evaluate Subjects With Multiple Myeloma Treated With GC012F Injection","Inclusion Criteria:\n\n* Patients with multiple myeloma who previously received GC012F Injection infusion in an investigator-initiated trial;\n* Patients who have completed the safety and efficacy follow-up of the main study or withdrawn early;\n* Patients who agree to sign the informed consent form and are willing and able to comply with the visits, laboratory tests, and other protocol requirements specified in the study visit schedule;\n\nExclusion Criteria:\n\n* Patients with multiple myeloma who participated in the main study but withdrew early without receiving GC012F Injection;\n* Patients who refuse to undergo long-term follow-up after GC012F Injection treatment;","ALL",{"count":100,"type":101},40,"ESTIMATED","OBSERVATIONAL","This is an open-label, multicenter, observational study (non-interventional study) to evaluate the long-term safety, efficacy, and in vivo pharmacokinetic persistence of CAR-T cells in subjects treated with GC012F Injection",[105],"Multiple Myeloma",[107,108],"Multiple myeloma","CAR-T cell therapy","NOT_YET_RECRUITING","2026-09-21",{"date":112,"type":113},"2026-09-22","ACTUAL",{"date":115,"type":101},"2026-10-15",{"date":117,"type":101},"2039-08-21",{"name":5,"class":6},1]