[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555682":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":32,"responsibleParty":48,"collaborators":50,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":20,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"920th Hospital of Joint Logistics Support Force of People's Liberation Army of China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Anti-BCMA CAR-T","EXPERIMENTAL","BCMA-GPRC5D CAR-T is a novel CAR cell therapy for the treatment of relapsed\u002Frefractory multiple myeloma.",[13],"Biological: Anti-BCMA-GPRC5D CAR-T cells infusion",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Anti-BCMA-GPRC5D CAR-T cells infusion","Subiects who meet the enrollment conditions will receive intravenous infusion of anti-BCMA-GPRC5D CAR-T Cells after lymphodepleting therapy.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Sanbin Wang","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Sanbin Wang, MD","CONTACT","13187424131","Sanbin1011@163.com",{"name":27,"role":28,"phone":20,"phoneExt":20,"email":20},[33],{"facility":23,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Kunming","Kunming, Yunnan","650100","China","CN",{"type":41,"coordinates":42},"Point",[43,44],102.71833,25.03889,{"lat":44,"lon":43},[47],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},{"type":49,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[51],{"name":52,"class":53},"Guangzhou Bio-gene Technology Co., Ltd","INDUSTRY","100555682","safety-and-efficacy-of-anti-bcma-gprc5d-car-t-cells-therapy-in-the-treatment-of-rr-mm-100555682",false,"NCT06515262","Safety and Efficacy of Anti-BCMA-GPRC5D CAR-T Cells Therapy in the Treatment of r\u002Fr MM","A Clinical Study to Evaluate the Safety and Efficacy of BCMA-GPRC5D CAR-T in Patients With Relapsed\u002FRefractory Multiple Myeloma Who Received Three or More Lines of Therapy","Inclusion Criteria:\n\n1. The patient or his\u002Fher guardian understands and voluntarily signs the informed consent, and is expected to complete the follow-up examination and treatment of the study procedure;\n2. Age 18-75 years old, gender unlimited;\n3. Diagnosed as Multiple Myeloma (MM) according to the international standard for multiple myeloma (IMWG);\n4. The presence of measurable disease at screening meets one of the following criteria:Serum M-protein ≥ 1.0 g\u002FdL or Urine M-protein ≥ 200 mg\u002F24h or diagnosed as Light-chain MM without measurable disease in serum and urine; Serum free light chain ≥ 10 mg\u002FdL with an abnormal κ\u002Fλ ratio;\n5. Patients must relapse or be refractory after three or more lines of therapy, which at least include: one Proteasome Inhibitor (PI), one Immunomodulatory Drug (IMiD), and one anti-CD38 monoclonal antibody;\n6. diagnosed as relapsed\u002Frefractory disease or primary refractory disease;\n7. The last treatment is ineffective, or the disease progresses within 60 days after the end of the last therapy;\n8. The patient has recovered from the toxicity of the prior treatment, i.e., CTCAE toxicity grade \\\u003C 2 (unless the abnormality is related to the tumor or is stable as judged by the investigator and has little impact on safety or efficacy);\n9. ECOG score 1-2 points and the expected survival period ≥ 3 months;\n10. Liver, kidney and cardiopulmonary functions meet the following requirements:\n\n    1. Total bilirubin ≤ 1.5×ULN, alanine aminotransferase (ALT) ≤ 3 × ULN and aspartate aminotransferase (AST) ≤ 3 × ULN;\n    2. Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 60 mL\u002Fmin;\n    3. Hemoglobin (Hb) ≥ 50 g\u002FL without prior blood transfusion within 7 days;\n    4. Baseline peripheral oxygen saturation \\> 92%;\n    5. Corrected serum calcium ≤ 12.5 mg\u002FdL (≤ 3.1 mmol\u002FL) or free (ionized, ionic) calcium ≤ 6.5 mg\u002FdL (≤ 1.6 mmol\u002FL);\n    6. Left ventricular ejection fraction (LVEF) \\> 45%, without confirmed pericardiac effusion and abnormal electrocardiography with clinical significance;\n    7. Without clinically significant pleural effusion;\n11. Venous access could be established; without contraindications of apheresis.\n\nExclusion Criteria:\n\n1. Have been diagnosed with or treated for aggressive malignancies other than multiple myeloma;\n2. Prior antitumor therapy (prior to blood collection for CAR-T preparation) : targeted therapy, epigenetic therapy, or investigational drug therapy within 14 days or at least 5 half-lives, whichever is shorter;\n3. It is suspected that MM has involved the central nervous system or meninges and has been confirmed by MRI or CT, or there are other active central nervous system diseases;\n4. Patients with Fahrenheit macroglobulinemia, POEMS syndrome, or primary AL, amyloidosis;\n5. Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive; HIV antibody positive; CMV DNA titer is higher than the lower limit of detection of the research institution; EBV DNA titer is higher than the lower limit of detection of the research institution;\n6. Patients have a severe allergic history;\n7. Any unstable systemic disease: including but not limited to unstable angina, cerebrovascular accident or transient cerebral ischemia (within 6 months before screening), myocardial infarction (within 6 months before screening), congestive heart failure \\[New York Heart Association (NYHA) classification ≥ grade III\\];\n8. Systemic diseases judged by researchers to be unstable: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;\n9. Patients with acute\u002Fchronic graft-versus-host disease (GVHD) or requiring immunosuppressive therapy for GVHD within 6 months prior to screening;\n10. Active autoimmune or inflammatory diseases of the nervous system;\n11. Patients develop oncology emergencies and need to be treated before screening or infusion;\n12. Uncontrolled infections that need antibiotics treatment;\n13. Exposure to hematopoietic growth factor of cells within 1-2 weeks before apheresis;\n14. Exposure to Corticosteriods or immunosuppressive agents within 2 weeks before apheresis;\n15. Patients receive a major surgical operation within 4 weeks before lymphodepletion or do not recover completely before the enrollment; or plan to receive a major surgical operation during the study period;\n16. Live attenuated vaccine within 4 weeks before screening;\n17. Persons with serious mental illness;\n18. Alcoholics or persons with a history of drug abuse;\n19. Pregnant or Lactating Women; Patients and his or her spouse have a fertility plan within two years after CAR-T cell infusion;\n20. Any unsuitable to participate in this trial judged by the investigator.","ALL","18 Years","75 Years",{"count":65,"type":66},10,"ESTIMATED","INTERVENTIONAL",[69],"NA","This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of bispecific BCMA-GPRC5D CAR-T cells in patients with relapsed or refractory multiple myeloma who received three or more lines of therapy.",[72],"Relapsed\u002FRefractory Multiple Myeloma",[74],"BCMA-GPRC5D CAR-T","2024-07-17",{"date":77,"type":78},"2024-07-23","ACTUAL",{"date":80,"type":78},"2024-07-01",{"date":82,"type":66},"2026-12",{"name":5,"class":6},1]