[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621351":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":41,"collaborators":20,"id":43,"slug":20,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":20,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":20,"enrollmentInfo":51,"targetDuration":20,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":20,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},{"fullName":5,"class":6},"Jiangsu Topcel-KH Pharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"BAFF-R CAR-T Cells treatment arm","EXPERIMENTAL","Subjects will be administrated with BAFF-R CAR-T Cells after lymphocyte depletion by fludarabine and cyclophosphamide.",[13],"Biological: BAFF-R CAR-T cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","BAFF-R CAR-T cells","BAFF-R CAR-T cells, single intravenous infusion",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Xiao Ma","CONTACT","0512-83837999","colleenld2020@hotmail.com",[28],{"facility":29,"status":30,"city":31,"state":20,"zip":20,"country":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Suzhou Hongci Hematology Hospital","RECRUITING","Suzhou","China",{"type":34,"coordinates":35},"Point",[36,37],120.59538,31.30408,{"lat":37,"lon":36},[40],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"type":42,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100621351",false,"NCT07369492","Safety and Efficacy Study of BAFF-R CAR-T Cells in Adult Subjects With CD19-Negative Relapsed or Refractory B-Cell Lymphoma","A Prospective, Open-label and Single-arm Study of BAFF-R CAR-T Cells in Adult Subjects With CD19-Negative Relapsed or Refractory B-Cell Lymphoma","Inclusion Criteria:\n\n* 1\\. Subjects voluntarily participate in clinical research and sign informed consent.\n* 2\\. Subjects with CD19-negative relapsed or refractory B-cell lymphoma: a) failure to achieve CR after 6 cycles, or PR after 3 cycles, of first-line therapy, or achieve CR after first-line therapy but relapse within 12 months; b) achieve CR after systemic treatment, but are refractory or relapsed, and no plan to transplant, or prepare for transplantation but cannot meet transplantation criteria after second-line therapy; c) not achieve CR after at least two courses of second-line treatment (including autologous stem cell transplantation).\n* 3\\. Expected survival ≥ 3 months.\n* 4\\. BAFF-R expression are detected on tumor cells of subjects by flow cytometry or immunohistochemistry.\n* 5\\. ECOG score ≤ 2.\n* 6\\. Subjects with adequate organ functions prior to enrollment, meet the following laboratory values:\n* Renal function: serum creatinine ≤ 1.5 × ULN or estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73 m²\n* Hepatic function: Serum alanine aminotransferase (ALT) ≤ 5 × age-specific ULN and total bilirubin ≤ 2.0 mg\u002FdL, except in subjects with Gilbert-Meulengracht syndrome. If total bilirubin ≤ 3.0 × ULN and direct bilirubin ≤ 1.5 × ULN, subjects with Gilbert-Meulengracht syndrome are included.\n* Pulmonary reserve: ≤ Grade 1 dyspnea and oxygen saturation \\>95% on room air.\n* 7\\. Stable hemodynamics and left ventricular ejection fraction (LVEF) ≥ 45 % assessed by echocardiography or multi-gated radionuclide angiography (MUGA).\n* 8\\. Adequate bone-marrow reserve without blood transfusion as defined by:\n* Absolute neutrophil count (ANC) ≥ 1 x 10\\^9\u002FL.\n* Absolute lymphocyte count (ALC) ≥ 0.1 x 10\\^9\u002FL.\n* Platelets ≥ 50 x 10\\^9\u002FL.\n* Hemoglobin \\>80g\u002FL.\n* 9\\. In the investigator's judgment, subjects' general condition and all biochemical values are either normal or sufficiently compensated to receive lymphodepletion and CAR-T cell therapy.\n\nExclusion Criteria:\n\n* 1\\. Women who are pregnant or breastfeeding, or planned pregnancy within 6 months.\n* 2\\. Infectious disease(HIV, Active Tuberculosis ect.).\n* 3\\. Active infection: hepatitis B, hepatitis C.\n* 4\\. Abnormal vital signs or refuse to receive examination.\n* 5\\. Subjects with psychiatric or psychological disorders are unable to complete treatment or efficacy assessment.\n* 6\\. History of severe hypersensitivity or known hypersensitivity to IL-2.\n* 7\\. Systemic or local severe infection requiring antimicrobial therapy.\n* 8\\. Significant dysfunction of vital organs (heart, lung, brain, kidney, etc.), or in the investigator's judgment, subjects are unable to be enrolled with any other condition.","ALL","18 Years",{"count":52,"type":53},30,"ESTIMATED","INTERVENTIONAL",[56],"PHASE1","The purpose of this study is to evaluate the safety and tolerability of BAFF-R CAR-T Cells in Adult Subjects with CD19-Negative relapsed or refractory B-Cell Lymphoma.",[59],"B-cell Lymphoma","2026-02-25",{"date":62,"type":63},"2026-02-27","ACTUAL",{"date":65,"type":63},"2026-01-01",{"date":67,"type":53},"2029-01",{"name":5,"class":6},1]