[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shenzhen Fosun Kairos Biotechnology Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":89},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,65],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100651763","phase-1-a-phase-iii-open-label-single-arm-multicenter-clinical-study-to-evaluate-the-safety-and-efficacy-of-fkc289-in-subjects-with-relapsedrefractory-membranous-nephropathy-100651763",false,"NCT07765537","A Phase I\u002FII Open-label, Single-arm, Multicenter Clinical Study to Evaluate the Safety and Efficacy of FKC289 in Subjects With Relapsed\u002FRefractory Membranous Nephropathy","Inclusion Criteria:\n\n1. Voluntarily signed the informed consent form (ICF);\n2. Aged between 18-70 years old (inclusive);\n3. Histologically confirmed diagnosis of primary membranous nephropathy by renal biopsy obtained within the past 2 years.;\n4. Relapsed or refractory disease;\n5. Anti-PLA2R antibody \\> 50 RU\u002FmL;\n6. 24-hour urine protein \\> 3.5 g at screening;\n7. No active systemic infection (e.g., infectious pneumonia, pulmonary tuberculosis) within 2 weeks prior to leukapheresis;\n8. Adequate bone marrow and major organ function (including hepatic, renal, cardiac, and pulmonary);\n\nExclusion Criteria:\n\n1. Secondary membranous nephropathy or patients with a prior diagnosis of other renal diseases;\n2. Presence of any clinically significant cardiovascular disease within 6 months prior to screening;\n3. Clinically significant central nervous system (CNS) disease or pathological abnormality;\n4. History of solid organ transplantation (e.g., heart, lung, kidney, liver);\n5. Presence of complete intestinal obstruction;\n6. Moderate to severe pleural effusion or ascites that is difficult to control with conventional treatment and requires continuous catheter drainage;","ALL","18 Years","70 Years",{"count":19,"type":20},55,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This Phase I study is designed to evaluate the safety and efficacy of FKC289 in subjects with relapsed\u002Frefractory Primary Membranous Nephropathy.The primary objectives are to assess the safety of FKC289 and to establish the recommended Phase II dose (RP2D).And this Phase II study is designed to evaluate the efficacy of FKC289.The primary objectives are to assess proportion of subjects achieving clinical response (including complete or partial response) at 6 months.",[27],"Primary Membranous Nephropathy","NOT_YET_RECRUITING","2026-08-11",{"date":31,"type":32},"2026-08-14","ACTUAL",{"date":34,"type":20},"2026-08",{"date":36,"type":20},"2030-03",{"name":38,"class":39},"Shenzhen Fosun Kairos Biotechnology Co., Ltd.","INDUSTRY",8,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":59,"startDateStruct":60,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100651730","phase-1-a-phase-iii-open-label-single-arm-multicenter-clinical-study-to-evaluate-the-safety-and-efficacy-of-fkc289-in-subjects-with-relapsedrefractory-primary-al-amyloidosis-100651730","NCT07765524","A Phase I\u002FII Open-label, Single-arm, Multicenter Clinical Study to Evaluate the Safety and Efficacy of FKC289 in Subjects With Relapsed\u002FRefractory Primary AL Amyloidosis","Inclusion Criteria:\n\n1. Voluntarily signed the informed consent form (ICF);\n2. Aged between 18-75 years old (inclusive);\n3. Confirmed clinical diagnosis of primary light chain (AL) amyloidosis;\n4. Relapsed or refractory disease;\n5. dFLC ≥ 40 mg\u002FL (based on central laboratory test results);\n6. ECOG performance status of 0 to 2;\n7. No active systemic infection within 2 weeks prior to leukapheresis;\n8. Adequate bone marrow and major organ function (including hepatic, renal, cardiac, and pulmonary);\n\nExclusion Criteria:\n\n1. Presence of any clinically significant cardiovascular disease within 6 months prior to screening;\n2. Clinically significant central nervous system (CNS) disease or pathological abnormality;\n3. History of solid organ transplantation (e.g., heart, lung, kidney, liver);\n4. Presence of complete intestinal obstruction;\n5. Moderate to severe pleural effusion or ascites that is difficult to control with conventional treatment and requires continuous catheter drainage;\n6. History of malignancy within 5 years prior to signing the ICF","75 Years",{"count":49,"type":20},32,[23,24],"This Phase I study is designed to evaluate the safety and efficacy of FKC289 in subjects with relapsed\u002Frefractory primary light chain (AL) amyloidosis.The primary objectives are to assess the safety of FKC289 and to establish the recommended Phase II dose (RP2D). And this Phase II study is designed to evaluate the efficacy of FKC289.The primary objectives are to assess proportion of subjects with hematologically best complete response (CR) within 6 months.",[53],"Primary Light Chain (AL) Amyloidosis",[55,56,57,58],"AL Amyloidosis","FKC289","BCMA\u002FCD19","autologous chimeric antigen receptor T cells",{"date":31,"type":32},{"date":34,"type":20},{"date":62,"type":20},"2029-09",{"name":38,"class":39},11,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100638503","early-phase-1-a-study-of-automated-axicabtagene-ciloleucel-for-rr-large-b-cell-lymphoma-100638503","NCT07606937","A Study of Automated Axicabtagene Ciloleucel for R\u002FR Large B-cell Lymphoma.","A Single-arm, Multicenter Clinical Study Evaluating the Efficacy and Safety of Axicabtagene Ciloleucel Injection Manufactured by an Automated Process in Patients With Relapsed\u002FRefractory Large B-cell Lymphoma.","Inclusion Criteria:\n\n1. Age 18 years or older at the time of informed consent\n2. Has signed the informed consent form (ICF)\n3. Histologically proven large B-cell lymphoma\n4. Relapsed or refractory disease after first-line chemoimmunotherapy\n5. The subject has at least one measurable lesion on imaging\n6. No clinical or historical evidence suggestive of lymphoma involvement of the central nervous system (CNS)\n7. A washout period of at least 2 weeks or 5 half-lives (whichever is shorter) from the last prior systemic therapy to the signing of the informed consent form.\n8. Toxicities due to prior therapy must be stable or recovered to ≤ Grade 1\n9. ECOG performance status of 0 or 1\n10. Adequate bone marrow, renal, hepatic, pulmonary and cardiac function\n11. Female subjects of childbearing potential must have a negative serum pregnancy test . Male and female subjects of childbearing potential must agree to use highly effective contraception during the study and for 6 months post-infusion.\n\nExclusion Criteria:\n\n1. Prior history of other malignancies, with the exception of non-melanoma skin tumors, carcinoma in situ , or follicular lymphoma that have been free of recurrence for more than 3 years.\n2. History of Richter's transformation of CLL or PMBCL\n3. History of autologous or allogeneic stem cell transplant\n4. Received more than one line of therapy for DLBCL\n5. Treatment with systemic immunostimulatory agents within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to the first dose of axicabtagene ciloleucel\n6. Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy\n7. History of severe, immediate hypersensitivity reaction attributed to aminoglycosides or Tocilizumab\n8. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management\n9. Known history of infection with human immunodeficiency virus (HIV) or Positive test result for anti-Treponema pallidum antibody (TP-Ab) or hepatitis B(HBsAg positive) or hepatitis C virus (anti-HCV positive)\n10. Active tuberculosis\n11. Presence of any indwelling line or drain\n12. Subjects with detectable malignant cells in the cerebrospinal fluid (CSF) or known brain metastases or with a history of cerebrospinal fluid malignant cells or brain metastases\n13. History or presence of non-malignant CNS disorder\n14. Subjects with cardiac atrial or cardiac ventricular lymphoma involvement\n15. History of clinically significant cardiac disease within 12 months of enrollment\n16. Requirement for urgent therapy within 6 weeks due to tumor mass effects, such as bowel obstruction or blood vessel compression or airway obstruction\n17. Patients with idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on chest CT are excluded.\n18. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment\n19. Women of childbearing potential who are pregnant or breastfeeding\n20. In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation",{"count":73,"type":20},12,[75],"EARLY_PHASE1","This study is a single-arm, multicenter, open-label clinical study evaluating the efficacy and safety of axicabtagene ciloleucel injection manufactured by an automated cell preparation process in adult subjects with relapsed or refractory large B-cell lymphoma (r\u002Fr LBCL) as second-line therapy.",[78],"Relapsed\u002FRefractory Large B-cell Lymphoma","RECRUITING","2026-06-02",{"date":82,"type":32},"2026-06-05",{"date":84,"type":20},"2026-06-12",{"date":86,"type":20},"2026-12-31",{"name":38,"class":39},6,""]