[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nanjing University School of Medicine\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":124},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,72,99],{"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":24,"conditions":25,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100619118","phase-2-the-efficacy-and-safety-of-biologics-belimumab-telitacicept-induction-therapy-in-proliferative-lupus-nephritis-patients-for-6-months-compared-with-mycophenolate-mofetil-treatment-100619118",false,"NCT07340463","The Efficacy and Safety of Biologics (Belimumab\u002F Telitacicept) Induction Therapy in Proliferative Lupus Nephritis Patients for 6 Months Compared With Mycophenolate Mofetil Treatment","Inclusion Criteria:\n\n* 1.Signed written informed consent form. 2.Age 14-65 years (inclusive), any gender. 3.Meets the American College of Rheumatology (ACR) SLE diagnostic criteria (1997).\n\n  4.All patients have biopsy-confirmed class III\u002FIV ± V LN within the past six months.\n\n  5.SLE-DAI score \\> 6. 6.Urine protein quantification \\> 1.0 g\u002Fd.\n\nExclusion Criteria:\n\n* 1.Estimated glomerular filtration rate (eGFR) ≥45 ml\u002Fmin\u002F1.73 m². 2.Patients who have received renal replacement therapy, plasma exchange, immunoadsorption, or high-dose intravenous immunoglobulin (100g) within the past 2 months.\n\n  3.Patients with concomitant critical organ damage or lupus crisis (e.g., pulmonary hemorrhage, encephalopathy, heart failure) deemed unsuitable for clinical trial participation by the investigator.\n\n  4.Hematological abnormalities: White blood cells \\\u003C3000\u002FμL, absolute neutrophil count \\\u003C1500\u002FμL, or lymphocytes \\\u003C800\u002FμL, platelet count \\\u003C50,000\u002FμL (unless due to SLE activity).\n\n  5.Liver function abnormalities: ALT, AST, or bilirubin levels exceeding 2 times the upper limit of normal.\n\n  6.Known allergy or contraindication to any component of belimumab and\u002For telitacicept.\n\n  7.Active infection or intravenous antibiotic use within 1 month prior to enrollment.\n\n  8.Pregnant or breastfeeding women. 9.Current or within the past 3 months: Active hepatitis B, hepatitis C, tuberculosis, cytomegalovirus pneumonia, active fungal infection, syphilis infection, or HIV infection; active peptic ulcer; history of drug abuse or alcoholism; severe malnutrition (BMI \\\u003C16 kg\u002Fm²).\n\n  10.Other conditions: Severe cardiovascular disease potentially life-threatening; chronic obstructive pulmonary disease, or asthma\u002Fallergic diseases requiring long-term oral steroid treatment; malignant hypertension; history of malignancy within the past 5 years (except for completely treated basal cell or squamous cell skin cancer or cervical intraepithelial neoplasia).\n\n  11.Other situations deemed unsuitable for enrollment by the investigator.","ALL","14 Years","65 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","1. Study Design This is a single-center, prospective, randomized, controlled, exploratory clinical trial. The study is designed to evaluate and compare the efficacy and safety of two biologic-based induction regimens against standard of care (SOC) and a triple-combination regimen in patients with active proliferative lupus nephritis (LN).\n2. Study Objectives Primary Objective: To compare the 6-month complete renal response (CRR) rate among patients receiving biologic-based induction therapy, SOC induction therapy, and triple-combination induction therapy.\n\n   Secondary Objectives: To compare the rates of partial renal response (PRR) and overall renal response (ORR) at monthly intervals up to Month 6; to assess the time to achieve CRR\u002FPRR; to evaluate changes in clinical and immunological parameters from baseline; and to compare the safety profiles of the three treatment regimens.\n3. Key Eligibility Criteria Patients aged 14-65 years with biopsy-proven active Class III or IV (±V) LN according to ISN\u002FRPS 2018 classification, an SLE-DAI score \\>6, and 24-hour urine protein \\>1.0 g\u002Fd will be eligible. Key exclusion criteria include an eGFR ≥45 ml\u002Fmin\u002F1.73m², recent use of renal replacement therapy or potent immunosuppressive procedures, significant concurrent infections, severe hematological\u002F hepatic abnormalities, and known hypersensitivity to the study biologics.\n4. Treatment Groups and Intervention\n\n   Eligible patients will be randomized in a 2:2:1 ratio to one of three treatment arms for a 6-month induction period:\n\n   Biologics Group (n≈20): Glucocorticoids + either Belimumab or Telitacicept. SOC Group (n≈20): Glucocorticoids + Mycophenolate Mofetil (MMF). Triple Therapy Group (n≈10): Glucocorticoids + MMF + either Belimumab or Telitacicept.\n\n   The choice between Belimumab and Telitacicept within the Biologics and Triple Therapy groups will be determined jointly by the investigator and the patient.\n5. Study Medications \\& Administration Glucocorticoids: All patients will receive oral prednisone (or equivalent) starting at 0.5 mg\u002Fkg\u002Fday (max 40 mg\u002Fday), with a mandatory taper to ≤5 mg\u002Fday by Month 4 and stable dosing from Months 5-6. Intravenous methylprednisolone pulses are permitted per investigator discretion.\n\n   Mycophenolate Mofetil (MMF): Administered only in the SOC and Triple Therapy groups. The target dose is 1.5-2.0 g\u002Fday, maintained until the end of the treatment period.\n\n   Belimumab: Administered via intravenous infusion at 10 mg\u002Fkg (600 mg\u002Fdose) every 2 weeks.\n\n   Telitacicept: Administered via subcutaneous injection at 160 mg once weekly. Patients in the Biologics or SOC groups showing no response by Month 3 may directly switch to the Triple Therapy regimen.\n6. Primary Efficacy Endpoint\n\nThe primary endpoint is the proportion of patients achieving Complete Renal Response (CRR) at Month 6. CRR is strictly defined as:\n\n24-hour urine protein \\\u003C0.5 g\u002Fd, AND Estimated Glomerular Filtration Rate (eGFR) ≥85% of the baseline value, AND No requirement for rescue therapy or premature treatment withdrawal. 7. Secondary Efficacy \\& Safety Assessments Key secondary efficacy assessments include monthly CRR, PRR, and ORR rates; time to response; incidence of renal-related events; and changes in proteinuria, eGFR, serum creatinine, and disease activity scores (SELENA-SLEDAI, BILAG-2004, PGA). Safety will be evaluated through the incidence and severity of adverse events, with special attention to infections, infusion\u002Finjection reactions, and metabolic parameters.\n\n8\\. Statistical Considerations This is an exploratory study with a planned enrollment of 40-50 patients. The primary analysis will use the Full Analysis Set (FAS) under the intention-to-treat principle. The difference in the Month 6 CRR rate among the three groups will be analyzed using the Chi-square test. Time-to-event data will be analyzed using the Kaplan-Meier method with Log-rank test for comparisons.\n\n9\\. Hypothesis: This study protocol outlines a head-to-head comparison of novel biologic-based induction strategies against current SOC for active LN. It aims to generate critical preliminary data on whether glucocorticoids combined with a biologic (Belimumab or Telitacicept) alone can induce effective renal remission, potentially offering a targeted treatment option with a different safety profile compared to conventional immunosuppressive therapy. The results may inform the design of larger, confirmatory trials in LN management.",[26,27],"Systemic Lupus Erythematosus (SLE)","Lupus Nephritis (LN)",[29,30,31,32,33],"SLE","LN","Belimumab","Lupus Nephritis","Telitacicept","RECRUITING","2026-03-10",{"date":37,"type":38},"2026-03-12","ACTUAL",{"date":40,"type":38},"2025-12-08",{"date":42,"type":20},"2029-06",{"name":44,"class":45},"Nanjing University School of Medicine","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":15,"minAge":54,"maxAge":17,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":46},"100538011","phase-1-the-bcmacd19-dual-targeted-car-t-cell-in-participants-with-autoimmune-kidney-diseases-100538011","NCT06285279","The BCMA\u002FCD19 Dual Targeted CAR-T Cell in Participants With Autoimmune Kidney Diseases","Evaluation of the Safety and Efficacy of the BCMA\u002FCD19 Dual Targeted CAR-T Cell in Participants With Autoimmune Kidney Diseases: A Single-center Exploratory Clinical Study","Inclusion Criteria:\n\n1. Participants must personally sign an informed consent form approved by the Ethics Committee before the start of the study.\n2. Participants must be aged ≥18 and ≤65 years.\n3. Disease-specific inclusion criteria:\n\n   Active, relapsing, refractory Lupus Nephritis (LN):\n\n   LN diagnosed by kidney biopsy within the last 2 years, with pathological types III, IV, or V, and a chronicity index (CI) score≤3\n\n   Meets one of the following criteria:\n\n   Refractory LN, defined as no remission after at least one standard regimen (CTX and\u002For MMF) for 6 months.\n\n   Relapsing LN, defined as a need to increase steroid dosage to control disease activity during maintenance treatment.\n\n   Clinical criteria: eGFR \\> 45 ml\u002Fmin\u002F1.73 m²; urinary protein quantification ≥ 1.5g\u002F24h; SLE-DAI score ≥ 8.\n\n   ANCA-associated vasculitis (AAV) patients:\n\n   Diagnosed as AAV according to the 2012 Chapel Hill Consensus Conference criteria, meeting one of the following:\n\n   Newly diagnosed AAV with renal involvement:\n\n   Renal involvement must meet both:\n\n   Kidney biopsy showing pauci-immune necrotizing glomerulonephritis. Urinary red blood cells \\>30\u002Fhigh power field.\n\n   Relapsing or refractory AAV:\n\n   Relapse: Defined as an increase in BVAS V3.0 score of ≥1 after remission, requiring adjustment of immunosuppressive treatment to regain remission.\n\n   Refractory: Defined as a) less than 50% reduction in BVAS V3.0 after 6 weeks of standard induction treatment; or b) persistent disease activity (BVAS V3.0 ≥3) after 12 weeks of treatment.\n\n   Membranous nephropathy (MN) patients:\n\n   Tissue biopsy diagnosed as aPLA2R-related membranous nephropathy.\n\n   Clinical criteria for high-risk or relapsing\u002Frefractory membranous nephropathy:\n\n   High-risk patients:\n\n   Defined as meeting any of the following: eGFR normal, urinary protein \\>3.5g\u002Fd, ACEI\u002FARB treatment for 6 months with \\\u003C50% reduction in urinary protein, combined with serum albumin \\\u003C25g\u002Fl or aPLA2R \\>50RU\u002Fml; or eGFR \\\u003C60ml\u002Fmin\u002F1.73m², and\u002For urinary protein \\>8g\u002Fd for over 6 months.\n\n   Refractory\u002Frelapsing membranous nephropathy patients:\n\n   Refractory: Defined as resistance to previous immunosuppressive treatment (persistent urinary protein ≥3.5g\u002Fd with \\\u003C50% reduction compared to baseline).\n\n   Relapse: Defined as complete or partial remission achieved with previous immunosuppressive treatment, followed by reappearance of urinary protein ≥3.5g\u002Fd.\n\n   eGFR ≥ 45 ml\u002Fmin\u002F1.73 m².\n\n   IgG4-related disease patients:\n\n   Meeting the 2019 ACR\u002FEULAR diagnostic criteria for IgG4-related disease, and meeting one of the following:\n\n   Newly diagnosed active IgG4-related disease (Respond Index (RI) ≥3).\n\n   Refractory or relapsed IgG4-related disease:\n\n   Refractory: Defined as no remission with steroid or steroid plus immunosuppressant treatment (no clinical or imaging improvement, RI decrease \\\u003C2) Relapse: Defined as new progression or recurrence of clinical symptoms or imaging findings in a patient who had achieved remission, with or without elevated blood IgG4 (RI increase≥2)\n4. Expected survival ≥ 12 weeks.\n5. ECOG performance status ≤ 2.\n6. Female participants of childbearing potential must agree to use effective contraception from the day of signing the informed consent until 365 days after the infusion. Effective contraception is defined as abstinence or the use of a contraceptive method with a failure rate of \\\u003C1% per year.\n7. Participants must have adequate organ function, meeting all of the following criteria before enrollment:\n\n   1. Absolute neutrophil count ≥ 1.0×10⁹\u002FL \\[Granulocyte colony-stimulating factor (G-CSF) support is allowed, but no supportive treatment should be received within 7 days before the assessment\\].\n   2. Platelet count ≥ 50×10⁹\u002FL \\[No transfusion support (including component transfusion) or treatments aimed\n\nExclusion Criteria:\n\n1. Participants who have received the following previous treatments:\n\n   1.1 Participants who have received gene therapy before enrollment. 1.2 Participants who have been injected with live vaccines within 4 weeks prior to enrollment.\n\n   1.3 Participants who have received other investigational drug treatments within 12 weeks before apheresis.\n2. Participants with active malignancies within the past 5 years, except for tumors deemed curable and cured, such as basal or squamous cell carcinoma, cervical or breast carcinoma in situ, etc.\n3. Participants who are positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) with abnormal peripheral blood HBV DNA tests (defined as HBV DNA quantification above the lower limit of detection or above the normal reference range of the testing center, or qualitative HBV DNA test positive); positive for Hepatitis C virus (HCV) antibodies with positive peripheral blood HCV RNA; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for Cytomegalovirus (CMV) DNA; positive for syphilis test RPR.\n4. Participants with uncontrolled active infections (except for \\\u003C Grade 2 CTCAE urinary reproductive system infections and upper respiratory infections).\n5. Participants with severe heart diseases, including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association \\[NYHA\\] class ≥ III), severe arrhythmias.\n6. Participants with hypertension or diabetes that cannot be controlled with medication.\n7. Participants with unresolved toxic reactions from previous treatments to baseline or ≤ Grade 1 (according to NCI-CTCAE v5.0, except for alopecia and clinically insignificant lab abnormalities).\n8. Participants who have undergone major surgery within 2 weeks prior to enrollment or plan to have surgery during the waiting period for infusion or within 12 weeks after receiving study treatment (except for planned minor surgeries under local anesthesia).\n9. Participants with solid organ transplants.\n10. Pregnant or breastfeeding women.\n11. Participants with a history of central nervous system diseases (such as cerebral aneurysm, epilepsy, stroke, dementia, psychosis, etc.) or consciousness disorders.\n12. Participants with other unstable systemic diseases as judged by the researcher, including but not limited to severe diseases of the liver, kidneys, gastrointestinal tract, or metabolic diseases requiring medication.\n13. Participants are known to have life-threatening allergic reactions, hypersensitivity, or intolerance to FKC288 cellular products or their components.\n14. Participants judged by the researcher to have bleeding, severe thrombosis, or hereditary\u002Facquired bleeding and severe thrombosis conditions (including hemophilia, coagulation dysfunction, thrombocytopenia, splenomegaly, etc.), or patients currently undergoing thrombolytic or anticoagulant therapy.\n15. Participants who have received any B cell-depleting therapy or non-depleting B cell targeted therapy within 6 months.\n16. Participants who have received high-dose methylprednisolone treatment (cumulative dose \\> 1.5g) or cyclophosphamide pulse therapy within a month.\n17. Participants judged by the researcher to be unable to discontinue other immunosuppressants one week before apheresis, or those treated with more than 5 mg\u002Fday of prednisone (or equivalent dose of other corticosteroids).\n18. AAV patients diagnosed with eosinophilic granulomatosis with polyangiitis (formerly Churg-Strauss syndrome) or with active alveolar hemorrhage.\n19. Other conditions deemed by the researcher as unsuitable for enrollment.","18 Years",{"count":56,"type":20},24,[58],"PHASE1","This study is a single-center, open-label, dose-escalation exploratory clinical trial, expected to enroll 6 to 12 participants. It will use a BOIN (Bayesian Optimal Interval) design for dose escalation, with four predetermined dose groups (0.3×10\\^6 cells\u002Fkg, 1.0×10\\^6 cells\u002Fkg, 3.0×10\\^6 cells\u002Fkg, and an alternative dose of 0.1×10\\^6 cells\u002Fkg). Each dose group plans to enroll 1-2 or 3-6 participants with relapsed or refractory autoimmune-mediated kidney diseases (such as lupus nephritis, ANCA-associated vasculitis, membranous nephropathy, and IgG4-related diseases).",[32,61,62,63],"ANCA-associated Vasculitis","Membranous Nephropathy - PLA2R Induced","IgG4-Related Diseases","2025-06-06",{"date":66,"type":38},"2025-06-11",{"date":68,"type":38},"2024-03-04",{"date":70,"type":20},"2028-12-31",{"name":44,"class":45},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":15,"minAge":54,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":46},"100545001","daratumumab-for-patients-with-light-chain-amyloidosis-100545001","NCT06376214","Daratumumab for Patients With Light Chain Amyloidosis","Daratumumab and Dexamethasone Combined With Pomalidomide (DPD) or ASCT in the Treatment of Newly Diagnosed Systemic Light Chain Amyloidosis (AL Amyloidosis): a Prospective, Single Center Clinical Trial","Inclusion Criteria:\n\n1. Participants must be aged ≥18 and ≤75 years;\n2. Newly diagnosed AL amyloidosis ((confirmed by pathological examination with at least one major organ involvement (heart, kidney, or liver));\n3. In group A and B, according to the Mayo 2004 staging system, the disease is classified as stage Ⅰ-ⅢA; In group C, according to the Mayo 2004 staging system, the disease is classified as stage IIIB: NT⁃proBNP\\>8500ng\u002FL and cTnT\\>0.035μg\u002FL or cTnI\\>0.01g\u002FL;\n4. Participants must personally sign an informed consent form approved by the Ethics Committee before the start of the study;\n5. Expected survival ≥ 12 weeks;\n6. ECOG performance status≤ 2;\n7. Female participants of childbearing potential must agree to use effective contraception from the day of signing the informed consent until 365 days after the infusion. Effective contraception is defined as abstinence or the use of a contraceptive method with a failure rate of \\\u003C1% per year.\n\nExclusion Criteria:\n\n1. eGFR\\\u003C 30ml\u002Fmin\u002F1.73m2;\n2. Combined multiple myeloma;\n3. Acute or chronic infection requiring treatment within 30 days prior to baseline;\n4. Pregnant or breastfeeding women.\n5. Participants known to have life-threatening allergic reactions, hypersensitivity, or intolerance to Monoclonal antibodies or immune modulators.\n6. Other conditions deemed by the researcher as unsuitable for enrollment.","75 Years",{"count":81,"type":20},100,[83],"NA","This is a prospective, single-center study exploratory clinical trial, aim to exploring the efficacy and safety of daratumumab in patients with AL amyloidosis, patients were divided into three groups: one group received long-term treatment with daratumumab based regimen, and the other group received autologous stem cell transplantation after two standard treatment courses with daratumumab based regimen, and the third group consists of newly diagnosed stage IIIb AL amyloidosis patients who plan to receive DPD treatment. The purpose of this study is to observe the efficacy and safety of Daratumumab, in the treatment of newly diagnosed systemic AL amyloidosis.",[86],"Light Chain (AL) Amyloidosis",[88,89,90],"light chain amyloidosis","daratumumab","stem cell transplantation","2024-04-16",{"date":93,"type":38},"2024-04-19",{"date":95,"type":38},"2023-01-01",{"date":97,"type":20},"2026-12-31",{"name":44,"class":45},{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":15,"minAge":54,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":21,"phases":109,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":46},"100514450","phase-1-fkc288-for-relapsed-or-refractory-systemic-light-chain-al-amyloidosis-100514450","NCT05978661","FKC288 for Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis","A Single-Center Exploratory Study to Evaluate the Safety and Efficacy of FKC288 in Subjects With Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis","Inclusion Criteria:\n\n1. The subject must personally sign a written informed consent form approved by the ethics committee before the start of the study;\n2. The subject's age is ≥18 years old and \\\u003C70 years old;\n3. The subject must be diagnosed with light chain amyloidosis by pathological examination, with at least one major organ involved (heart, kidney, or liver);\n4. The subject with recurrent\u002Frefractory light chain amyloidosis that achieved no response with conventional treatment;\n5. dFLC \\> 50mg\u002FL;\n6. Expected survival ≥ 12 weeks;\n7. ECOG score ≤ 2 points;\n8. Female subjects with fertility should agree to practice an effective method of contraception from the day of signing the ICF until 365 days after the infusion. An effective method of contraception is defined as abstinence or contraceptive methods with an annual failure rate of \\\u003C1% specified in the plan.\n9. Before enrollment, the subject must have appropriate organ function and meet all the following criteria:\n\n1\\) Absolute neutrophil count ≥ 1.0×109\u002FL (use of granulocyte colony-stimulating factor (G-CSF) support is allowed, but must be without supportive treatment within 7 days before the examination); 2) Platelet count ≥ 75×109\u002FL (no transfusion support \\[including component transfusion\\] or treatments aimed at raising platelets such as thrombopoietin \\[TPO\\] should be received within 7 days before the examination); 3) Hemoglobin ≥ 9 g\u002Fdl (no transfusion support \\[including component transfusion\\] should be received within 7 days before the examination); 4) Bilirubin value ≤ 1.5× upper limit of normal (ULN) (except bile duct obstruction caused by tumor compression); 5) Creatinine clearance rate ≥ 40 ml\u002Fmin; 6) ALT or AST ≤ 2.5× ULN (≤5 times the upper limit of normal in patients with liver involvement); 7) Echocardiography results indicate left ventricular ejection fraction ≥ 50% with no significant pericardial effusion; 8) NTproBNP \\\u003C 1800pg\u002Fml, TNT \\\u003C 0.06ng\u002Fml; 9) Stable coagulation function: INR ≤ 1.5, APTT ≤ 1.2× ULN (excluding tumor-related anticoagulant therapy); 10) \\>95% basic blood oxygen saturation in the natural indoor air environments.\n\nExclusion Criteria:\n\n1. Subjects who have received any of the following treatments prior to enrollment: 1) Subjects who have received gene therapy before enrollment; 2) Subjects who have received live vaccines within 4 weeks prior to enrollment; 3) Subjects has received other interventional clinical research drugs within 12 weeks before apheresis.\n2. Subjects with central metastasis or complete intestinal obstruction.\n3. Subject with moderate or more severe hydrothorax and ascites which are hard to control by conventional treatment and require continuous catheter drainage.\n4. With an active malignant tumor in the past 5 years, unless it is a curable tumor and has been obviously cured.\n5. Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and have abnormal peripheral blood HBV DNA test results (HBV DNA test abnormality is defined as HBV DNA quantitative detection is higher than the detection center's detection lower limit or higher than the detection center's normal reference range or HBV DNA qualitative detection is positive); hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; the cytomegalovirus (CMV) DNA positive; syphilis testing RPR positive.\n6. Presence of uncontrollable active infections (excluding \\\u003CCTCAE grade 2 urinary and respiratory tract infections).\n7. Severe cardiovascular diseases, including but not limited to unstable angina pectoris, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ III), and severe arrhythmias.\n8. Subjects with hypertension that cannot be controlled by medication.\n9. Toxicity reactions that have not been relieved to baseline or ≤ grade 1 (NCI-CTCAE version 5.0, except for hair loss and laboratory test abnormalities without clinical significance) from past treatments.\n10. Major surgery within 2 weeks before enrollment, or has a surgery planned during the time the subject is expected to be infused with FKC288 or within 12 weeks after FKC288 infusion (except planned surgery under local anesthesia).\n11. Subject who has a solid organ transplant.\n12. Women who are pregnant or breastfeeding.\n13. Subjects with previous central nervous system diseases (such as cerebral aneurysm, epilepsy, stroke, dementia, psychosis, etc.) or conscious disorders.\n14. Other systemic diseases that the investigator judges as unstable, including but not limited to severe liver, kidney, or metabolic diseases that require medication.\n15. Known life-threatening allergic reactions, hypersensitivity reactions, or intolerance to FKC288 cell preparations or their components.\n16. Subjects judged by the investigator to have bleeding or severe thrombosis, or have inherited\u002Facquired bleeding and severe thrombosis (including hemophilia, coagulation dysfunction, thrombocytopenia, splenomegaly, etc.), or are receiving thrombolysis or anticoagulation therapy.\n17. Other situations deemed inappropriate for inclusion by the investigator.","70 Years",{"count":108,"type":20},12,[58],"This study is a single-center exploratory clinical trial. It is estimated that 6-12 subjects will be enrolled. The \"BOIN\" dose escalation design is adopted. The main purpose is to evaluate the safety of FKC288 in the treatment of subjects with relapsed or refractory AL amyloidosis and explore the recommended phase II dose of FKC288 in the treatment of patients with relapsed\u002Frefractory systemic Light Chain (AL) amyloidosis.",[112],"Light Chain Amyloidosis",[114,115],"AL Amyloidosis","BCMA\u002FCD19-CAR-T cell","2023-11-13",{"date":118,"type":38},"2023-11-15",{"date":120,"type":38},"2023-08-29",{"date":122,"type":20},"2026-06",{"name":44,"class":45},""]