[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526282":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":29,"responsibleParty":47,"collaborators":51,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":18,"studyType":69,"phases":70,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":32,"whyStopped":18,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Xuzhou Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients treated with CAR T cells","EXPERIMENTAL","Peripheral blood mononuclear cells were collected and subjected to CD3+T cells were enriched, transfected with APRIL-BAFF-Bicephali lentiviral vector, expanded by in vitro culture, and pretreated with clear lymphocytes using the FC protocol before infusion of APRIL-BAFF-Bicephali CAR-T cells.",[13],"Other: APRIL-BAFF-Bicephali CAR-T cells",[15],{"type":6,"name":16,"description":11,"armGroupLabels":17,"otherNames":18},"APRIL-BAFF-Bicephali CAR-T cells",[9],null,[20],{"name":21,"affiliation":22,"role":23},"Kailin Xu MD, PD","The Affiliated Hospital oh Xuzhou Medical University","STUDY_CHAIR",[25],{"name":21,"role":26,"phone":27,"phoneExt":18,"email":28},"CONTACT","15162166166","lihmd@163.com",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Kailin Xu","RECRUITING","Xuzhou","Jiangsu","221000","China","CN",{"type":39,"coordinates":40},"Point",[41,42],117.28386,34.20442,{"lat":42,"lon":41},[45],{"name":46,"role":26,"phone":27,"phoneExt":18,"email":28},"Kailin Xu, M.D., Ph.D.",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Kai Lin Xu，MD","professor",[52],{"name":53,"class":54},"Yake Biotechnology Ltd.","INDUSTRY","100526282","phase-1-safety-and-efficacy-of-april-baff-bicephali-car-t-in-relapsed-refractory-multiple-myeloma-100526282",false,"NCT06132711","Safety and Efficacy of APRIL-BAFF-Bicephali CAR-T in Relapsed, Refractory Multiple Myeloma","Safety and Efficacy of APRIL-BAFF-Bicephali CAR-T in Relapsed, Refractory Multiple Myeloma-A Single-center, Open-label, Single-arm Clinical Study","CAR-T","Inclusion Criteria:\n\nThe set subject inclusion criteria include multiple documents of multiple myeloma, no effective treatment options (e. g. autologous or allogeneic stem cell transplantation) and limited outcome (\\\u003C2 years) with existing therapies, as follows:\n\n1. Age is 18\\~70 years old;\n2. Expected survival period of\\>12 weeks;\n3. Multiple myeloma was diagnosed by physical examination, pathological examination, laboratory examination and imaging;\n4. Patients with refractory multiple myeloma;\n5. Patients with multiple myeloma recurrence;\n6. ALT and AST \\\u003C3 times normal; bilirubin \\\u003C2.0mg \u002F dl;\n7. Quality of survival score (KPS)\\> 50%;\n8. The patient has no serious heart, liver, kidney and other diseases;\n9. Recurrence or no disease remission after hematopoietic stem cell transplantation or cellular immunotherapy;\n10. Is not suitable for stem cell transplantation conditions or to abandon transplantation due to conditional restrictions;\n11. Blood can be obtained intravenously, without other contraindications to leukapheresis;\n12. Understand and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\nExclusion criteria\n\n1. Women who are pregnant or breastfeeding, or who have a pregnancy plan within six months;\n2. Infectious diseases (such as HIV, active tuberculosis, etc.);\n3. Active hepatitis B or hepatitis C infection;\n4. Feasibility assessment screening demonstrated \\\u003C10% transfection of targeted lymphocytes or underamplification under CD3 \u002F CD28 co-stimulation (\\\u003C5-fold);\n5. Abnormal vital signs, and unable to cooperate with the examination;\n6. Have mental or mental illness who cannot cooperate with the treatment and efficacy evaluation;\n7. Highly allergic constitution or have a history of severe allergies, especially allergic to IL-2;\n8. Subjects with a systemic infection or a severe local infection requiring anti-infective treatment;\n9. Subjects with severe autoimmune disease;\n10. The doctor believes there were other reasons for inclusion.","ALL","18 Years","70 Years",{"count":67,"type":68},20,"ESTIMATED","INTERVENTIONAL",[71,72],"PHASE1","PHASE2","This is a Single-center, open, single-arm clinical study, the goal of which was to evaluate the safety and efficacy of APRIL-BAFF-Bicephali CAR-T in relapsed and refractory multiple myeloma.The study consisted of four processes: patient enrollment screening; pre-CAR T cell therapy (including leukocyte apheresis, CAR T cell preparation and chemotherapy); inpatient monitoring phase for CAR T cell transfusion; and long-term follow-up phase",[75],"Multiple Myeloma",[77],"myeloma, Chimeric antigen receptor, April, TACI","2023-11-14",{"date":80,"type":81},"2023-11-15","ACTUAL",{"date":83,"type":81},"2023-11-10",{"date":85,"type":68},"2027-01-01",{"name":5,"class":6},1]