[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574430":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":34,"studyPopulation":27,"armGroups":35,"interventions":42,"overallOfficials":27,"centralContacts":48,"locations":54,"responsibleParty":68,"collaborators":27,"id":73,"slug":27,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":27,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":27,"studyType":85,"phases":86,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":57,"whyStopped":27,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Xuzhou Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"Adverse events","Adverse events assessed according to NCI-CTCAE v5.0","Baseline up to 28 days after CAR-T cells infusion",[14,18,21,24],{"measure":15,"description":16,"timeFrame":17},"overall response rate (ORR)","Assessment of ORR at Month 6, 12, 18 and 24","Month 6, 12, 18 and 24",{"measure":19,"description":20,"timeFrame":17},"complete response (CR)","Assessment of CR at Month 6, 12, 18 and 24",{"measure":22,"description":23,"timeFrame":17},"Overall survival (OS)","Assessment of OS at Month 6, 12, 18 and 24",{"measure":25,"description":26,"timeFrame":17},"Event-free survival (EFS)","Assessment of EFS at Month 6, 12, 18 and 24",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":27,"primaryPurpose":31,"observationalModel":27,"timePerspective":27,"maskingInfo":32},"NA","SINGLE_GROUP","TREATMENT",{"masking":33,"maskingDescription":27,"whoMasked":27},"NONE","This open label, single-arm, Phase 2 study aims to evaluate the efficacy and safety of Anti-BCMA\u002FFcRL5 CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture. Anti-FcRL5 chimeric antigen receptor (CAR) modified T cells. Prior to Anti-BCMA\u002FFcRL5 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide. After infusion, the investigators will observe the characteristics of dose limited toxicity (DLT), and determine the maximum tolerable agent MTD and rp2d were confirmed. To provide basis for the dosage and treatment plan of cell products in follow-up clinical trials.",[36],{"label":37,"type":38,"description":39,"interventionNames":40},"anti BCMA\u002FFcRL5 CAR-T","EXPERIMENTAL","anti-BCMA\u002FFcRL5 autologous CAR T cells will be infused at a dose ranging from 1 - 2 x 10\\^6\u002Fkg CAR+ T cells after receiving lymphodepleting chemotherapy.",[41],"Drug: anti-BCMA\u002FFcRL5 CAR T",[43],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":27},"DRUG","anti-BCMA\u002FFcRL5 CAR T","anti-BCMA\u002FFcRL5 autologous CAR T cells will be infused at a dose ranging from 1 - 2 x 10\\^6\u002Fkg CAR+ T cells after receiving lymphodepleting chemotherapy.\n\nOther Name:",[37],[49],{"name":50,"role":51,"phone":52,"phoneExt":27,"email":53},"Kailin Xu, PhD","CONTACT","15162166166","lihmd@163.com",[55],{"facility":56,"status":57,"city":56,"state":27,"zip":27,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Xuzhou","RECRUITING","China","CN",{"type":61,"coordinates":62},"Point",[63,64],117.28386,34.20442,{"lat":64,"lon":63},[67],{"name":50,"role":51,"phone":52,"phoneExt":27,"email":53},{"type":69,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":72,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Kai Lin Xu，MD","Pr.","The Affiliated Hospital of Xuzhou Medical University","100574430",false,"NCT06759181","Safety and Efficacy of Anti-BCMA\u002FFcRL5 CAR-T Cell Therapy in Treating Relapsed and Refractory Multiple Myeloma (R\u002FR MM)","Efficacy and Safety Study of Anti-BCMA\u002FFcRL5 CAR-T Cells in Subjects With Relapsed and Refractory Multiple Myeloma","Inclusion Criteria:\n\nAge is 18\\~70 years old; Expected survival period of\\>12 weeks; Multiple myeloma was diagnosed by physical examination, pathological examination, laboratory examination and imaging; Patients with refractory multiple myeloma; Patients with multiple myeloma recurrence; ALT and AST \\\u003C3 times normal; bilirubin \\\u003C2.0mg \u002F dl; Quality of survival score (KPS)\\> 50%; The patient has no serious heart, liver, kidney and other diseases; Recurrence or no disease remission after hematopoietic stem cell transplantation or cellular immunotherapy; Is not suitable for stem cell transplantation conditions or to abandon transplantation due to conditional restrictions; Blood can be obtained intravenously, without other contraindications to leukapheresis; Understand and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\nWomen who are pregnant or breastfeeding, or who have a pregnancy plan within six months; Infectious diseases (such as HIV, active tuberculosis, etc.); Active hepatitis B or hepatitis C infection; Feasibility assessment screening demonstrated \\\u003C10% transfection of targeted lymphocytes or underamplification under CD3 \u002F CD28 costimulation (\\\u003C5-fold); Abnormal vital signs, and unable to cooperate with the examination; Have mental or mental illness who cannot cooperate with the treatment and efficacy evaluation; Highly allergic constitution or have a history of severe allergies, especially allergic to IL-2; Subjects with a systemic infection or a severe local infection requiring anti-infective treatment; Subjects with severe autoimmune disease; The doctor believes there were other reasons for inclusion","ALL","18 Years","70 Years",{"count":83,"type":84},20,"ESTIMATED","INTERVENTIONAL",[87,88],"PHASE1","PHASE2","This is an open label, single-arm, Phase 2 study to evaluate the efficacy and safety of Anti-BCMA\u002FFcRL5 CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture. Anti-BCMAFcRL5 chimeric antigen receptor (CAR) modified T cells. Prior to Anti-BCMA\u002FFcRL5 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.",[91],"Multiple Myeloma",[93,94,95],"multiple myeloma","BCMA","FcRL5","2024-12-29",{"date":98,"type":99},"2025-01-06","ACTUAL",{"date":101,"type":84},"2024-12-31",{"date":103,"type":84},"2027-12-31",{"name":5,"class":6},1]