[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574430":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":41,"collaborators":20,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":20,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":20,"studyType":59,"phases":60,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Xuzhou Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Drug: anti-BCMA\u002FFcRL5 CAR T",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"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:",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Kailin Xu, PhD","CONTACT","15162166166","lihmd@163.com",[28],{"facility":29,"status":30,"city":29,"state":20,"zip":20,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Xuzhou","RECRUITING","China","CN",{"type":34,"coordinates":35},"Point",[36,37],117.28386,34.20442,{"lat":37,"lon":36},[40],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":45,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Kai Lin Xu，MD","Pr.","The Affiliated Hospital of Xuzhou Medical University","100574430","phase-1-safety-and-efficacy-of-anti-bcmafcrl5-car-t-cell-therapy-in-treating-relapsed-and-refractory-multiple-myeloma-rr-mm-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":57,"type":58},20,"ESTIMATED","INTERVENTIONAL",[61,62],"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.",[65],"Multiple Myeloma",[67,68,69],"multiple myeloma","BCMA","FcRL5","2024-12-29",{"date":72,"type":73},"2025-01-06","ACTUAL",{"date":75,"type":58},"2024-12-31",{"date":77,"type":58},"2027-12-31",{"name":5,"class":6},1]