[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-systemic-lupus-erythematosus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-systemic-lupus-erythematosus":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,42,69,106,133,155],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100568085","phase-1-nk010-or-nk042-in-combination-with-rituximab-for-refractory-systemic-lupus-erythematosuslupus-nephritis-100568085",false,"NCT06676631","NK010 or NK042 in Combination With Rituximab for Refractory Systemic Lupus Erythematosus\u002FLupus Nephritis","NK010 or NK042 Cell Injection in Combination With Rituximab in Patients With Refractory Systemic Lupus Erythematosus or Lupus Nephritis","Inclusion Criteria:\n\n* 18 to 65 years old, male or female.\n* A diagnosis of SLE according to the 2019 EULAR (European League Against Rheumatism)\u002FACR (American College of Rheumatology).\n* Inclusion criteria applicable to the LN subgroup: active type III or IV lupus nephritis (with or without type V) confirmed by renal biopsy according to the 2018 International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) criteria. An activity index ≥2 and a chronicity index no more than moderate according to the 2018 RPS Task Force for LN pathologic types and the National Institutes of Health (NIH) Lupus Nephritis Activity and Chronicity Index Score criteria. Urine protein\u002Fcreatinine ratio (UPCR) ≥ 1.0 g\u002Fg or 24-hour urine protein quantification ≥ 1.0 g\u002Fday.\n* One of the following at screening: positive antinuclear antibody (ANA) OR positive anti-dsDNA OR positive anti-Smith antibody.\n* SLEDAI-2000 score ≥ 8.\n* Prior to screening, having received glucocorticoids combined with immunosuppressants and\u002For biologics for at least 3 months with stable doses for \\>2 weeks, but disease still active (i.e., received glucocorticoids + immunosuppressants or glucocorticoids + immunosuppressants + biologics; monotherapy with any of the above drugs is not eligible).\n* Hematologic, hepatic, renal, pulmonary, and cardiac function criteria at screening were as follows: ① leukocytes ≥ 2 ×109\u002FL and lymphocyte count ≥ 0.5 ×109 \u002FL; ② serum ALT and AST ≤ 3 times the upper limit of normal; ③ total bilirubin ≤ 1.5 times the upper limit of normal, with the exception of patients with Gilbert's syndrome, for whom total bilirubin was ≤ 3.0 times the upper limit of normal; ④ eGFR (based on the creatinine based on the CKD-EPI formula) ≥ 30 ml\u002Fmin\u002F1.73m2; ⑤ oxygen saturation ≥ 92% in non-oxygenated state under indoor ventilation; no clinically significant pleural effusion; ⑥ left ventricular ejection fraction ≥ 45%, and no clinically significant abnormal findings on ECG.\n* For participants not receiving therapeutic anticoagulation: International standardized ratio (INR) ≤ 1.5 times the upper limit of normal, or prothrombin time (PT) ≤ 1.5 times the upper limit of normal.\n* Participants receiving hematopoietic growth factor support therapy, including erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage-colony-stimulating factor (GM-CSF), and platelet agonists (TPO), must have a 2-week interval between the last growth factor support therapy and the screening period assessment; those receiving blood product transfusion that require at least 1 week between the screening period platelet assessment and the last platelet transfusion, and at least 2 weeks between the screening period hemoglobin assessment and the last red blood cell transfusion.\n* Female participants of childbearing potential must have a negative serum pregnancy test at screening (women who are surgically sterilized or have been menopausal for at least 2 years are not considered to be of childbearing potential). Female subjects of childbearing potential and male subjects must use highly effective methods of contraception throughout the clinical study and for 1 year after the last study treatment; they should also commit not to donate eggs (oocytes, oocytes)\u002Fsperm for assisted reproduction for 1 year after the last study treatment.\n* Participants are willing to participate in this study and sign a paper version of the informed consent form.\n\nExclusion Criteria:\n\n* Requires dialysis treatment (hemodialysis or peritoneal dialysis) at the time of screening or is expected to require dialysis treatment during study treatment.\n* Have received a solid organ or hematopoietic cell transplant or plan to do so during study period.\n* Have a congenital or acquired immunodeficiency that results in a serious infection, or are receiving chronic immunoglobulin replacement therapy.\n* Presence of active mixed connective tissue or systemic sclerosis, an overlapping syndrome, in the 12 months prior to or during screening, and the adverse condition or other treatment may affect study efficacy or safety assessment or outcomes. Overlapping syndromes in which the anticipated condition or treatment does not affect the assessment or outcome are not excluded.\n* Receipt of any B-cell depletion therapy (e.g., anti-CD20, anti-CD19 monoclonal antibody), including but not limited to zolmitriptan in rituximab, obinutuzumab, bortezomib, within 6 months prior to screening; or treatment with any biologic, such as, but not limited to, belimumab, anifrolumab, or tetracycline, within 1 month prior to screening.\n* Participants with known anaphylaxis, hypersensitivity, intolerance, or contraindication to NK010 Cell Injection, NK042 Cell Injection, RTX, or any of the components of the drugs that may be used in the study, or subjects who have had a previous severe allergic reaction.\n* Clinically significant central nervous system disease or pathological changes not due to lupus within 3 months prior to the first dose, including, but not limited to, cerebrovascular accident (ischemia\u002Fhemorrhage), aneurysm, epilepsy, convulsions\u002Fconvulsions, aphasia, severe brain injury, dementia, parkinson's disease, cerebellar disorders, organic brain syndromes, or psychiatric disorders.\n* Unstable cardiovascular function: ① Uncontrollable angina pectoris or life-threatening unstable arrhythmia; ② Myocardial infarction or unstable angina pectoris within 3 months prior to the screening; ③ Previous coronary artery or graft revascularization; ④ Uncontrolled, clinically significant arrhythmia (e.g., sustained ventricular tachycardia, ventricular fibrillation, tip-twisting); ⑤ Mobitz type II Mobitz type II or III atrioventricular block; (6) congestive heart failure or severe cardiac insufficiency with New York Heart Association classification ≥ grade 3; (7) prolongation of the QT interval (QTc) corrected for heart rate (Fridericia) by \\> 480 milliseconds; (8) uncontrolled hypertension (systolic blood pressure \\>160 mm Hg and\u002For diastolic blood pressure \\> 100 mm Hg), or associated with hypertensive crisis or hypertensive encephalopathy.\n* Active bleeding.\n* Any active infection, excluding fungal infections of the nail beds; history of severe recurrent or chronic infections.\n* Presence of active infection treated with intravenous antibiotics within 14 days prior to screening, except for antibiotic prophylaxis (including intravenous administration).\n* Positive serum HIV viral antibodies or history of active HIV infection and positive syphilis antibodies at screening.\n* Positive Hepatitis B Surface Antigen (HBsAg). Participants who are HBsAg negative and Hepatitis B Core Antibody (HBcAb) positive, but Hepatitis B Virus (HBV) DNA negative are eligible for enrollment, but will require monitoring of HBV DNA at each follow-up visit.\n* Positive Hepatitis C Serology. Participants with hepatitis C antibodies positive but do not have detectable hepatitis C virus (HCV) RNA for at least 6 months after completion of antiviral therapy are eligible for enrollment, but require monitoring of HCV RNA at each follow-up visit.\n* Risk of active tuberculosis at screening, with or without completion of adequate treatment, including the presence of signs or symptoms of active tuberculosis (e.g., fever, cough, night sweats, and weight loss) as judged by the investigator at screening; documented active tuberculosis on chest imaging (e.g., chest x-ray, chest CT scan) performed at screening or at any time during the 6 months prior to screening; latent tuberculosis at screening evidence of infection such as a positive gamma-interferon release test.\n* Participants with a malignant tumor, including tumor-associated polymyositis\u002Fdermatomyositis, within 5 years prior to screening. Except for surgically resected and cured non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, low-stage bladder cancer, ductal carcinoma in situ of the breast, or cured participants with no evidence of recurrence within the last 2 years and no need for treatment.\n* Previous received cell therapy such as CAR-T, CAR-NK, ect.\n* Pregnant or lactating women, or (if of childbearing potential) subjects who are not using adequate contraception or planning to donate oocytes and sperm.\n* The presence of any life-threatening disease, medical condition, or organ system dysfunction that, in the opinion of the Investigator, may affect the safety of the subject or compliance with the study.","ALL","18 Years","65 Years",{"count":20,"type":21},18,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is an investigator-initiated, open-label, single-arm study to determine safety and preliminary efficacy of NK010 or NK042 in combination with rituximab (RTX) for the treatment of patients with refractory systemic lupus erythematosus (SLE) or lupus nephritis (LN) in China.",[27,28],"Refractory Systemic Lupus Erythematosus","Refractory Lupus Nephritis","RECRUITING","2026-06-10",{"date":32,"type":33},"2026-06-12","ACTUAL",{"date":35,"type":33},"2025-02-19",{"date":37,"type":21},"2027-12-31",{"name":39,"class":40},"Guangdong Provincial People's Hospital","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":41},"100638640","early-phase-1-iaso207-injection-for-active-refractory-systemic-lupus-erythematosus-sle-100638640","NCT07617740","IASO207 Injection for Active Refractory Systemic Lupus Erythematosus (SLE)","An Exploratory Clinical Study on the Treatment of Active Refractory Systemic Lupus Erythematosus With IASO207 Injection","Inclusion Criteria:\n\n1. Subjects aged 18-75 years old, regardless of gender.\n2. Subjects diagnosed with active refractory SLE: a) Confirmed by the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus Erythematosus Collaborative Clinic (SLICC) criteria for at least 24 weeks; b) SLE Disease Activity Index 2000 (SLEDAI-2K) score ≥ 8, with at least 1 organ system having a BILAG-2004 A-class activity score at screening, or 2 organ systems having a BILAG-2004 B-class activity score; c) Previously treated with standardized glucocorticoids and at least two immunosuppressants\u002Fadjusters, antimalarial drugs or biologics for at least 3 months.\n3. Positive for disease-related pathogenic antibodies: Anti-nuclear antibody (ANA) positive and\u002For anti-dsDNA positive and\u002For anti-Smith positive.\n4. Allowed to use ≤ 20mg\u002Fd prednisone or equivalent dose of corticosteroids at screening, and use at a stable dose for at least 2 weeks. Note: Local or inhaled corticosteroids (or its immunomodulators) can be used concurrently;\n5. If antimalarial treatment has been initiated for ≥ 12 weeks before screening and is used at a stable dose for at least 8 weeks, it is allowed to continue in the study (maximum hydroxychloroquine dose ≤ 400mg\u002Fd).\n6. If immunosuppressants have been used before screening, they must be used at a stable dose for at least 4 weeks.\n7. Laboratory tests must meet the following conditions: a) Blood routine: Absolute neutrophil count (ANC) ≥ 1.0×10\\^9\u002FL; Absolute lymphocyte count (ALC) ≥ 0.3×10\\^9\u002FL; Hemoglobin ≥ 60 g\u002FL; Platelets ≥ 50×10\\^9\u002FL b) Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5× upper limit of normal (ULN); Serum total bilirubin ≤ 1.5×ULN (Gilbert's syndrome ≤ 3.0×ULN).\n8. The subject and their spouse agree to take effective contraceptive measures (excluding safe period contraception) from the time of signing the informed consent form by the subject until one year after IASO207 injection treatment.\n9. The subject must agree to sign or personally write and present the signed informed consent form approved by the ethics committee before starting any screening procedure.\n\nExclusion Criteria:\n\nDisease-related:\n\n1. Diagnosed with drug-induced SLE.\n2. Complicated with other autoimmune diseases that may affect the assessment of the study, including but not limited to Sjögren's syndrome, psoriasis, rheumatoid arthritis.\n3. Had a catastrophic antiphospholipid syndrome or developed a severe antiphospholipid syndrome within 1 year before screening.\n4. The study disease involved neurological symptoms with a BILAG-2004 activity score of class A.\n\n   Other medical history-related:\n5. Known primary immunodeficiency (congenital or acquired).\n6. The subject has uncontrollable active fungal, viral, bacterial or other infections (existing persistent infection-related signs\u002Fsymptoms, not improved after appropriate anti-infection treatment) or requires intravenous anti-infection drug treatment for infection.\n7. Positive hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb) and abnormal peripheral blood hepatitis B virus (HBV) DNA detection (defined as HBV DNA quantification above the normal reference range of the testing center or positive HBV DNA qualitative detection); positive hepatitis C virus (HCV) antibody and positive peripheral blood hepatitis C virus (HCV) RNA; positive Human Immunodeficiency Virus (HIV) antibody; positive cytomegalovirus (CMV) DNA detection; positive Treponema pallidum specific antibody and positive rapid plasma reagin test for syphilis.\n8. Severe heart disease: including but not limited to unstable angina pectoris and\u002For myocardial infarction within 12 months of screening, any congestive heart failure (NYHA classification ≥ III), and a history of severe arrhythmia; or left ventricular ejection fraction (LVEF) \\\u003C 45%.\n9. Severe asthma or chronic obstructive pulmonary disease (COPD), with stable treatment considered for mild or moderate asthma or COPD by the investigator and sponsor; or resting arterial blood oxygen saturation \\\u003C 91%.\n10. Evaluated by the investigator as having a severe bleeding risk.\n11. Evaluated by the investigator as having severe liver dysfunction.\n12. History of severe kidney disease; or eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.\n13. Acute cerebrovascular disease events occurred within 6 months before enrollment, including transient ischemic attack or stroke history.\n14. Any severe and\u002For uncontrolled comorbid diseases as assessed by the investigator.\n15. Had a malignant tumor within 5 years before screening, excluding cured cervical carcinoma in situ, basal cell or squamous cell skin cancer, locally advanced prostate cancer after radical surgery, breast duct carcinoma in situ after radical surgery, or papillary thyroid carcinoma after radical surgery.\n16. Had a clear history of mental disorder or a history of substance abuse for mental disorders that cannot be quit.\n17. Known allergy to the components of IASO207 injection or to the supportive drugs required for the toxicity management of CAR-T cell therapy (such as tocilizumab).\n\n    Previous and concurrent treatments:\n18. History of organ transplantation.\n19. History of autologous or allogeneic stem cell transplantation.\n20. History of cell therapy or CD19-targeted drug treatment.\n21. Received targeted CD20 biologic therapy within 12 weeks before screening, such as rituximab, obinutuzumab.\n22. Received plasma exchange or immunoadsorption treatment within 12 weeks before screening.\n23. Had or planned to have major surgery or surgical treatment caused by any reason within 12 weeks before screening.\n24. Have participated in the treatment of other investigational drugs (except for placebo) within the previous 4 weeks or 5 half-lives (whichever is longer);\n25. Have received a BAFF antagonist, such as belimumab or tixagevimab, within the previous 4 weeks;\n26. Have received live attenuated vaccine within the previous 4 weeks;\n27. Pregnant or lactating women;\n28. Other situations deemed unsuitable for inclusion by the investigators.","75 Years",{"count":20,"type":21},[52],"EARLY_PHASE1","This is a single-center, open-label, exploratory clinical study designed to evaluate the efficacy and safety of IASO207 Injection (in vivo CAR-T) in patients with active refractory systemic lupus erythematosus.",[55],"REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS",[57,58,59],"systemic lupus erythematosus","Refractory","in vivo CAR-T","2026-05-23",{"date":62,"type":33},"2026-06-01",{"date":64,"type":21},"2026-05-25",{"date":66,"type":21},"2030-05-30",{"name":68,"class":40},"Peking University People's Hospital",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":41},"100633196","phase-1-select-sle-biomarker-guided-car-t-target-selection-for-refractory-lupus-100633196","NCT07523542","SELECT-SLE: Biomarker-Guided CAR-T Target Selection for Refractory Lupus","A Phase 1\u002F2, Open-Label, Biomarker-Guided, Non-Randomized, Multicenter Study of Autologous CAR-T Cell Therapy Targeting CD19 or BCMA in Adults With Refractory Systemic Lupus Erythematosus With or Without Active Lupus Nephritis.","SELECT-SLE","Inclusion Criteria:\n\n* 1\\. Age 18 to 70 years at consent. 2. Meets 2019 EULAR\u002FACR classification criteria for SLE, with total score \\>= 10.\n\n  3\\. Active refractory disease at screening, defined by SELENA-SLEDAI \\>= 8, or at least one BILAG A domain, or at least two BILAG B domains, or active lupus nephritis with significant proteinuria and active urinary sediment.\n\n  4\\. Inadequate response, intolerance, or contraindication to at least 2 prior standard systemic regimens, including at least 1 immunosuppressant or biologic used for SLE or lupus nephritis. 5. Demonstrable targetable biology and assignment to one protocol arm: CD19 arm for measurable CD19-positive B-cell \u002F B-cell-dominant disease, or BCMA arm for BCMA-positive plasmablast \u002F plasma-cell-dominant disease and\u002For persistent serologic activity after prior B-cell depletion. 6. If active lupus nephritis is present, biopsy-proven class III, IV, V, or mixed proliferative \u002F membranous LN within the previous 24 months, or investigator confirmation that repeat biopsy is unsafe but the clinical picture strongly supports active LN. 7. Adequate organ function: hemoglobin \\>= 8.5 g\u002FdL, ANC \\>= 1.0 x 10\\^9\u002FL, platelets \\>= 50 x 10\\^9\u002FL, AST \u002F ALT \\\u003C= 2.5 x ULN, creatinine clearance \\>= 30 mL\u002Fmin, bilirubin \\\u003C= 2.0 mg\u002FdL unless otherwise explained, and LVEF \\>= 50%.\n\n  8\\. Adequate venous access and eligibility for leukapheresis. 9. Negative pregnancy test and agreement to use effective contraception for 12 months after infusion.\n\n  10\\. Ability to discontinue prohibited SLE medications per washout rules and willingness to comply with inpatient observation and long-term follow-up. 11. Written informed consent.\n\nExclusion Criteria:\n\n* 1\\. Active uncontrolled infection, including active tuberculosis, hepatitis B or C with active replication, or HIV.\n\n  2\\. Prior CAR-T therapy or prior CD19- or BCMA-directed cell therapy. 3. Severe active CNS lupus requiring urgent escalation of immunosuppression, uncontrolled seizure disorder, or stroke within 60 days before screening. 4. End-stage organ failure not expected to improve with immune reset, such as dialysis-dependent kidney failure, uncontrolled advanced heart failure, or ICU-level respiratory instability. 5. Active malignancy or history of malignancy within 5 years, except adequately treated non-melanoma skin cancer, cervical carcinoma in situ, or other low-risk malignancy in durable remission. 6. Pregnant or breastfeeding. 7. Allogeneic hematopoietic stem cell transplant or solid organ transplant history.\n\n  8\\. Contraindication to fludarabine, cyclophosphamide, leukapheresis, or standard rescue medications for CRS \u002F ICANS. 9. Live vaccine within 4 weeks before lymphodepletion. 10. Participation in another interventional clinical study within 3 months before enrollment.\n\n  11\\. Uncontrolled psychiatric disease, active substance misuse, or social circumstances that would impair adherence.\n\n  12\\. Any condition that, in the investigator's judgment, makes participation unsafe or confounds interpretation of the study endpoints.","70 Years",{"count":79,"type":21},24,[24,81],"PHASE2","study evaluates a biomarker-guided strategy to assign adults with refractory SLE to autologous CAR-T therapy targeting either CD19 or BCMA. Participants undergo centralized screening immunophenotyping to determine whether their disease appears B-cell-dominant (CD19-preferred) or plasma-cell-dominant (BCMA-preferred), followed by leukapheresis, lymphodepletion, and a single CAR-T infusion. The main goals are to assess safety, determine a recommended Phase 2 dose within each arm, and estimate remission rates by Week 24.",[55,84],"Lupus Nephritis",[86,87,88,89,90,91,92,93,94,95],"autologous T cells","B-cell depletion","BCMA","biomarker-guided therapy","CAR-T","CD19","immune reset","lupus nephritis","plasma-cell depletion","refractory lupus","2026-04-05",{"date":98,"type":33},"2026-04-13",{"date":100,"type":33},"2026-03-02",{"date":102,"type":21},"2028-10-17",{"name":104,"class":105},"Beijing Biotech","INDUSTRY",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":118,"conditions":119,"keywords":120,"overallStatus":123,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":41},"100626184","phase-1-cd19-car-t-cell-therapy-for-refractory-systemic-lupus-erythematosus-100626184","NCT07432334","CD19 CAR T-Cell Therapy for Refractory Systemic Lupus Erythematosus","Evaluation of the Safety and Efficacy of CD19 CAR T-Cell Therapy for the Treatment of Refractory Systemic Lupus Erythematosus: A Phase I Clinical Trial","Inclusion Criteria:\n\n* Age 16 to 55 years, male or female\n* Diagnosis of systemic lupus erythematosus (SLE) according to the 2019 EULAR\u002FACR classification criteria with a total score ≥ 10\n* SLEDAI-2K score ≥ 8 at screening (with at least 4 points derived from laboratory parameters; excluding points attributable to central nervous system involvement)\n* Positive antinuclear antibody (ANA ≥ 1:80) OR positive anti-dsDNA OR positive anti-Sm antibody at screening or documented in medical history\n\nRefractory systemic lupus erythematosus or refractory lupus nephritis defined as one of the following:\n\nRefractory SLE:\n\n\\- Failure to achieve adequate response, partial response, or stable disease control after ≥ 6 months of standard-of-care therapy (documented compliance). Standard therapy includes corticosteroids plus hydroxychloroquine and at least two of the following: calcineurin inhibitors, cyclophosphamide, mycophenolate mofetil, azathioprine, or B-cell-targeted therapy (e.g., rituximab, belimumab).\n\nRefractory Lupus Nephritis:\n\n* Persistent active lupus nephritis after two induction regimens, including intravenous cyclophosphamide and mycophenolate mofetil administered for ≥ 6 months (with or without calcineurin inhibitors, rituximab, or belimumab), AND:\n* Histopathologic confirmation of Class III or Class IV lupus nephritis, with or without Class V (ISN\u002FRPS 2003 classification); isolated Class V is excluded\n* Proteinuria \\> 1 g\u002F24 hours OR urine protein-to-creatinine ratio \\> 1 mg\u002Fmg\n* Adequate organ function:\n\n  * ALT ≤ 5 × upper limit of normal; total bilirubin ≤ 34 μmol\u002FL (≤ 2.0 mg\u002FdL)\n  * Pulmonary function: FVC ≥ 60% predicted OR FEV1 ≥ 60% predicted\n  * Cardiac function: LVEF ≥ 50%, no uncontrolled arrhythmia, no intracardiac thrombus, no heart failure\n* Adequate hematologic parameters:\n\n  * Absolute neutrophil count ≥ 0.8 × 10⁹\u002FL (without growth factor support)\n  * Absolute lymphocyte count ≥ 0.3 × 10⁹\u002FL\n  * Platelet count ≥ 50 × 10⁹\u002FL\n  * Hemoglobin ≥ 80 g\u002FL (≥ 8.0 g\u002FdL)\n* Ability to provide written informed consent\n* Agreement to use effective contraception during the study period (for participants of reproductive potential)\n\nExclusion Criteria:\n\n* History of significant neurologic disorders (e.g., traumatic brain injury, seizure disorder, hemorrhagic conditions, impaired consciousness)\n* Significant cardiovascular disease within 3 months prior to screening (e.g., uncontrolled hypertension, NYHA Class III-IV heart failure, severe arrhythmia, unstable angina, myocardial infarction)\n* Prior kidney transplantation\n* Severe asthma requiring long-term treatment or respiratory failure\n* Severe hemolytic anemia requiring transfusion at intervals ≤ 7 days\n* Active viral infections (e.g., hepatitis B or C, HIV, tuberculosis, malaria, syphilis, CMV, EBV) or other life-threatening infectious diseases\n* Active bacterial infection confirmed by clinical evaluation, imaging, or laboratory testing\n* Use of the following prior to leukapheresis:\n\n  * Anti-CD20 therapy, cyclophosphamide, live or attenuated vaccines within 1 month\n  * Systemic corticosteroids \\> 10 mg\u002Fday (prednisone equivalent), T-cell-targeted therapy (e.g., mycophenolate mofetil, calcineurin inhibitors), immunosuppressive agents, or antimalarial agents within 7 days\n  * Prior anti-CD19 therapy\n  * Prior T-cell-based cellular therapy or gene therapy, including CAR-T therapy\n* Current or prior malignancy\n* Known hypersensitivity to study-related agents\n* Pregnant or breastfeeding women\n* Active antiphospholipid syndrome (stable antiphospholipid antibody positivity without active APS is permitted)\n* Participation in another clinical trial at the time of screening\n* Any condition that, in the investigator's judgment, would interfere with protocol compliance or study participation","16 Years","55 Years",{"count":116,"type":21},8,[24],"The goal of this Phase I clinical trial is to evaluate the safety and tolerability of autologous CD19-targeted chimeric antigen receptor T-cell (CAR-T) therapy in adults with refractory systemic lupus erythematosus who have demonstrated inadequate response to standard-of-care immunosuppressive treatments.\n\nThe primary questions this study aims to address are:\n\nWhat is the incidence, nature, and severity of treatment-emergent adverse events following CD19 CAR-T cell infusion? Is administration of CD19 CAR-T cell therapy feasible and tolerable in patients with refractory systemic lupus erythematosus? This study is conducted as a single-arm trial without a comparison group.\n\nParticipants will:\n\nUndergo leukapheresis for collection of autologous peripheral blood mononuclear cells Receive a protocol-defined lymphodepleting chemotherapy regimen prior to CAR-T cell infusion Receive a single intravenous infusion of approximately 1.0 × 10⁶ CD19 CAR-T cells per kilogram of body weight Undergo scheduled clinical evaluations, laboratory testing, and longitudinal follow-up to assess safety, tolerability, and clinical parameters",[27],[121,122],"CD19 CAR-T","Autoimmune Disease","NOT_YET_RECRUITING","2026-02-24",{"date":126,"type":33},"2026-02-25",{"date":128,"type":21},"2026-03-01",{"date":130,"type":21},"2027-11",{"name":132,"class":40},"Vinmec Research Institute of Stem Cell and Gene Technology",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":143,"conditions":144,"keywords":145,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":153,"locationsCount":41},"100555541","im19-car-t-cell-therapy-in-refractory-systemic-lupus-erythematosus-sle-100555541","NCT06513429","IM19 CAR-T Cell Therapy in Refractory Systemic Lupus Erythematosus (SLE)","Clinical Study on Evaluating the Efficacy and Safety of IM19 CAR-T Cell Therapy in Patients With Refractory Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* 1)The subject was diagnosed with systemic lupus erythematosus and met the classification criteria of EULAR\u002FACR 2019 SLE (see Annex 2)\n* 2\\) Age ≥ 18 years old, ≤ 65 years old\n* 3\\) Weight ≥ 40 kg\n* 4\\) Meets the current clinical standards for refractory systemic lupus erythematosus: the disease remains active or relapses and progresses after systemic treatment using the current standard treatment regimen, including steroids (sufficient or shock therapy), immunosuppressants (cyclophosphamide or mycophenolate mofetil), and biologics (belizumab or Rituximab)\n* 5\\) Currently, one or more of the following stable dose standard therapies are being used to treat SLE: steroids, antimalarial drugs, immunosuppressants. If the subject is receiving steroids, the following conditions must be met: at screening time and during screening period, the maximum dose of steroids is 30mg\u002Fday prednisone (or equivalent dose). Before screening, the dose of steroids should remain stable for ≥ 7 days. During the screening period, the dose of steroids adjustment should not exceed 5mg\u002Fday prednisone (or equivalent dose). If the subject is receiving treatment with antimalarial drugs and\u002For conventional immunosuppressants: the start time of drug treatment must be ≥ 12 weeks before screening. Maintain a stable dose of medication for at least 8 weeks before and during screening. Before the screening period, if biological agents (such as belizumab or Telitacicept) are used, they need to be discontinued for at least 4 weeks before screening.\n* 6\\) Disease activity score (SLEDAI-2K) with a score of 10 or above (refer to Attachment 3)\n* 7\\) Women of childbearing age who tested negative for blood pregnancy before the start of the trial and agreed to take effective contraceptive measures during the trial period until the last follow-up\n* 8\\) Male participants whose partners have fertility agree to take effective contraceptive measures during the trial period until the last follow-up\n\n  * 9\\) Those who voluntarily participate in this experiment and sign an informed consent form.\n\nExclusion Criteria:\n\n* 1\\) After evaluation by researchers, it is determined that the subject has diseases that are not suitable for participation in this study, such as life-threatening conditions (e.g., catastrophic antiphospholipid syndrome, acute severe renal failure, acute severe central nervous system disease manifestations).\n* 2\\) The research subject has a history of alcohol or drug abuse within the past 24 weeks.\n* 3\\) The research subject has a history of malignant tumors other than B-cell lymphoma.\n* 4\\) Major surgery (including joint surgery) was performed within 24 weeks prior to screening, or surgery is planned within 24 weeks after enrollment in the study.\n* 5\\) The research subject has overlapping mixed connective tissue diseases and other syndromes that affect the judgment of disease activity.\n* 6\\) The research subject has human immunodeficiency virus (HIV) infection, selective IgA deficiency, T-cell deficiency virus infection, chronic hepatitis B or C virus infection, or SARS-CoV-2 \\[severe acute respiratory syndrome coronavirus 2\\] infections.\n* 7\\) The research subject has a known active tuberculosis (TB) infection or bacterial infection.\n* 8\\) History of myocardial infarction, cardiac angioplasty or stent placement, unstable angina, active arrhythmia, or other clinically significant heart disease within 6 months prior to screening initiation.\n* 9\\) History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to screening initiation.\n* 10\\) The research subject's alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) levels are ≥3×ULN, or bilirubin \\>1.5×ULN, excluding laboratory test abnormalities due to SLE hepatitis.\n* 11\\) The research subject has stage 4 chronic kidney failure, indicated by an estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m², or serum creatinine \\>2.5 mg\u002FdL. During the screening visit (V1), the research subject presents with any of the following significant hematological abnormalities: a. Hemoglobin \\\u003C7.0 g\u002FdL b. CD4+ T lymphocytes \\\u003C200\u002Fmm³ c. Absolute neutrophil count \\\u003C500\u002Fmm³ d. CD4+ T lymphocytes \\\u003C500\u002Fmm³ with a neutrophil count \\\u003C1000\u002Fmm³ e. Platelets \\\u003C25,000\u002Fmm³.\n* 12\\) Treatment with CD20 monoclonal antibodies was used within the past 6 months.\n* 13\\) Conditions that the researcher considers unsuitable for inclusion in this clinical trial.",{"count":5,"type":21},[142],"NA","The study is a single-arm, open-label clinical trial intended to recruit 6 refractory SLE subjects who meet the inclusion and exclusion criteria. The subjects will receive IM19 CAR-T cell infusion therapy at a dose of 1×10\\^6\u002Fkg or 1×10\\^8 CAR-T cells . The primary endpoint is to evaluate the improvement in SLE disease activity (SLEDAI-2K) at 90 days and the occurrence of adverse events related to IM19 CAR-T cell infusion within 28 days post-infusion. Additionally, the long-term efficacy was evaluated, including the improvement of SLEDAI-2K score and achieving lupus low disease activity (LLDAS) at day 180 and day 360, and renal response at day 180 and day 360. The persistence and duration of IM19 CAR-T cells in the peripheral blood of subjects will also be evaluated. The study plan includes five phases: screening phase, cell collection phase, lymphodepletion pretreatment phase, cell infusion phase, and follow-up phase.",[27],[57,146],"CAR-T cell","2025-08-13",{"date":149,"type":33},"2025-08-17",{"date":151,"type":33},"2024-07-30",{"date":37,"type":21},{"name":154,"class":40},"Peking University Third Hospital",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":77,"enrollmentInfo":162,"targetDuration":4,"studyType":22,"phases":164,"briefSummary":165,"conditions":166,"keywords":167,"overallStatus":123,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":4},"100599350","nk510-cell-therapy-for-refractory-systemic-lupus-erythematosus-100599350","NCT07083349","NK510 Cell Therapy for Refractory Systemic Lupus Erythematosus","An Open, Single-Center Exploratory Clinical Study of NK510 Cell Therapy for Refractory Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* 18 to 70 years old, male or female.\n* A diagnosis of SLE according to the 2019 EULAR (European League Against Rheumatism)\u002FACR (American College of Rheumatology).\n* The subject voluntarily participates in this clinical study and signs the Informed Consent Form (ICF).\n* Before screening, the subject must have received glucocorticoid combined with immunosuppressants and\u002For biological agents for at least 2 months, with a stable dose for more than 2 weeks, but the disease remains active; within 7 days before lymphodepleting conditioning, the blood routine test must meet the following requirements: absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL; hemoglobin (Hb) ≥ 80g\u002FL; platelet count (PLT) ≥ 50×10⁹\u002FL.\n* SLEDAI-2K score \\> 8 points at screening.\n* Antinuclear antibody (ANA) ≥ 1:80 at screening.\n* Having appropriate organ functions:\n\n  1. Liver function: aspartate transaminase (AST) ≤ 3 times the upper limit of normal (ULN); alanine transaminase (ALT) ≤ 3 times ULN; total bilirubin ≤ 1.5 times ULN, unless the subject has a record of Gilbert syndrome; subjects with Gilbert-Meulengracht syndrome with total bilirubin ≤ 3.0 times ULN and direct bilirubin ≤ 1.5 times ULN can be included;\n  2. Renal function: serum creatinine ≤ 1.5 times ULN, or creatinine clearance rate ≥ 60 mL\u002Fmin;\n  3. Blood routine: absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL; absolute lymphocyte count (ALC) ≥ 0.1×10⁹\u002FL; hemoglobin (Hb) ≥ 80 g\u002FL; platelet count (PLT) ≥ 50×10⁹\u002FL.\n* Women of childbearing age must be non-lactating and have a negative serum pregnancy test within 1 week before administration. In addition, all subjects (whether male or female) must agree to use contraception during the period of NK510 treatment starting from enrollment and within 3 months after the end of treatment.\n* Able to comply with the study protocol and follow-up procedures.\n\nExclusion Criteria:\n\n* Patients with active lupus nephritis.\n* Those with allergies to the study drug or other medications used in the study protocol.\n* Those with any of the following conditions: ① Having received autologous\u002Fallogeneic hematopoietic stem cell transplantation within 3 months; ② Having received ultraviolet irradiation therapy within 6 weeks; ③ Having received biologic agent therapy (excluding other medications used in the study protocol) within 4 weeks or 3 half-lives (whichever is longer); ④ Having undergone major surgery or received live vaccines within 4 weeks; ⑤ Having received experimental treatment (except for definite placebo control groups) within 4 weeks.\n* Those with other active, known, or suspected autoimmune diseases.\n* Presence of uncontrolled active bacterial, viral, fungal, mycobacterial, or other infections requiring treatment with intravenous antibiotics, antiviral drugs, or antifungal drugs within 14 days before lymphodepleting conditioning; however, prophylactic use of these drugs (including intravenous administration) is allowed.\n* History of immunodeficiency, including positive HIV test results, or other acquired\u002Fcongenital immunodeficiency diseases, or history of organ transplantation.\n* History of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac rhythm or conduction abnormalities (e.g., ventricular arrhythmias requiring clinical intervention, third-degree atrioventricular block, etc.); QTc interval \\> 480 ms on 12-lead electrocardiogram at rest; acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events within 6 months before administration; New York Heart Association (NYHA) cardiac function class ≥ II or left ventricular ejection fraction (LVEF) \\\u003C 50%.\n* Failure to fully recover from major surgery or trauma within 2 weeks before administration.\n* History of malignant tumors.\n* Screening results of hepatitis B or C virological tests meeting any of the following:\n\n  1. HBsAg positive, and peripheral blood HBV-DNA titer ≥ 1×10³ copies\u002FmL or upper limit of normal;\n  2. Anti-HCV positive.\n* Those deemed unsuitable for participation in the study by the investigator.",{"count":163,"type":21},9,[142],"This is an investigator-initiated, open-label, single-arm study to determine safety and preliminary efficacy of NK510 for the treatment of patients with refractory systemic lupus erythematosus (SLE) in China.",[27],[168],"SLE","2025-07-23",{"date":171,"type":33},"2025-07-28",{"date":173,"type":21},"2025-08-01",{"date":175,"type":21},"2027-09-01",{"name":177,"class":105},"Base Therapeutics (Shanghai) Co., Ltd."]