[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-lupus-nephritis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-lupus-nephritis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,66,85],{"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":49,"maxAge":18,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":64,"locationsCount":41},"100588904","phase-1-umbilical-cord-blood-cd19-bcma-cart-cell-therapy-for-sle-ln-ssc-andpss-pah-100588904","NCT06947473","Umbilical Cord Blood CD19-BCMA CART Cell Therapy for SLE-LN, SSc, andpSS PAH.","Single Center, Open Label, Non Randomized, Single Arm Clinical Study of Cord Blood CD19-BCMA CART Cell Therapy for Refractory Lupus Nephritis (SLE-LN), Systemic Sclerosis (SSc), and Primary Sjogren's Syndrome With Pulmonary Hypertension (pSS PAH)","Inclusion Criteria:\n\n* 1\\. Refractory lupus nephritis (LN):\n\nAccording to the 2019 American College of Rheumatology (ACR) criteria and the 2018 International Society of Nephrology (ISN)\u002FSociety of Nephrology (RPS) criteria (see Appendix 3), confirmed by renal tissue biopsy as active, proliferative lupus nephritis, type III or IV \\[excluding type III (C), IV-S (C), and IV-G (C)\\], or type III\u002FIV combined with type V. Biopsy must be performed within 6 months prior to the screening visit or during the screening period.\n\n1. Male or female patients aged 3-65 years old;\n2. Systemic lupus erythematosus that meets the 2019 American College of Rheumatology (ACR)\u002FEuropean Union of Rheumatology Associations (EULAR) classification criteria (see Annex 5);\n3. The result of the anti nuclear antibody (ANA) test is clearly positive, that is, the ANA titer is ≥ 1:80 (equivalent test result based on Hep-2 immunofluorescence detection method or enzyme immunoassay method), and\u002For at the screening visit, the anti dsDNA serum antibody test is positive (≥ 30 IU\u002FmL based on ELISA detection method) according to the test results of the research center laboratory.\n4. B cell CD19+expression and discontinuation of immunosuppressive agents for more than 1 week;\n5. No severe allergic constitution;\n6. Physical condition score (ECOG) 0-2 points;\n7. Expected survival period ≥ 90 days;\n8. The subjects and\u002For their guardians are able to understand and willing to sign a written informed consent form; 2. Systemic sclerosis (SSc):\n\n\u003C!-- -->\n\n1. The selected patient or their legal representative voluntarily signs the informed consent form.\n2. Age range: 6-65 years old (including 6 and 65 years old), gender is not limited.\n3. According to the SSc classification criteria proposed by the American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) in 2013, the highest score under the same item, ≥ 9 points, can be classified as SSc (Attachment 6).\n4. Or if one sufficient condition is met, that is, the skin of both fingers thickens and extends to the proximal end of the metacarpophalangeal joint, it can be directly classified as SSc.\n\n3\\. Primary Sjogren's syndrome with pulmonary hypertension (pSS PAH):\n\n(1) The selected patients or their legal representatives voluntarily sign informed consent.\n\n(2) Age range: 18-65 years old (including 18 and 65 years old), gender is not limited.\n\n(3) Patients with refractory connective tissue disease (pulmonary arterial hypertension):\n\n1. Diagnosed with primary Sjogren's syndrome according to the 2002 AECG classification criteria or the 2016 ACR\u002FEULAR classification criteria\n2. Confirmed by right heart catheterization to meet the diagnostic criteria for PAH (as defined in the 2022 ESC\u002FERS guidelines for the diagnosis and treatment of pulmonary arterial hypertension):\n\n   * Resting mean pulmonary artery pressure (mPAP) ≥ 20mmHg;\n\n     * Pulmonary artery wedge pressure (PAWP) ≤ 15mmHg;\n\n       ③ Resting pulmonary vascular resistance (PVR)\\>2WU; (4) PAH did not reach the risk stratification of low-risk group patients. Low risk patients need to meet: ① WHO heart function classification I-II; ② 6-minute walking distance (6MWD)\\>440 meters; ③ BNP\\\u003C50ng\u002FL， Or NT proBNP\\\u003C300ng\u002FL; ④ Right atrial pressure (RAP)\\\u003C8mmHg and cardiac index (CI) ≥ 2.5 L · min-1 · m-2.\n\n       (5) Prior to the first administration of the investigational drug, a stable dose of standard treatment was received, including corticosteroids (prednisone 0-30mg\u002Fday, or equivalent other formulations) for at least 4 weeks; Antimalarial drugs and monotherapy immunosuppressants (allowed immunosuppressants are limited to: mycophenolate mofetil or mycophenolate mofetil ≤ 1.5g\u002Fday, azathioprine or 6-mercaptopurine ≤ 2mg\u002Fkg\u002Fday, methotrexate ≤ 15mg\u002Fweek, leflunomide ≤ 20mg\u002Fday) should be used for at least 12 weeks, and should not be increased or replaced within 24 weeks after drug treatment. Prior to drug treatment, use PAH targeted drugs of less than three types (including prostaglandin analogs, endothelin receptor antagonists, PDE-5 inhibitors, and guanylate cyclase agonists), which have been stable for at least 4 weeks and have not been increased or replaced within 24 weeks after drug treatment.\n\n       (6) Clinicians assess the patient's condition and allow the use of corticosteroids at a dose not exceeding 10mg prednisone or its equivalent during the study period, and allow the discontinuation of all immunosuppressants (excluding hydroxychloroquine).\n\n       (7) Women of childbearing age have a negative blood pregnancy test within 7 days prior to the pre-treatment treatment; Any male and female patient with fertility must agree to use an effective contraceptive method throughout the entire study process and for at least one year through the infusion of cell injection. The patient's fertility refers to their biological ability to give birth to live infants and have normal sexual activity. Female patients who are infertile (i.e. meet at least one of the following criteria): have undergone hysterectomy or bilateral oophorectomy, or have been medically confirmed to have ovarian failure, or have been medically confirmed to be postmenopausal (with at least 12 consecutive months of amenorrhea without pathological or physiological reasons).\n\n       (8) Having appropriate organ function, it must meet the following standards: Aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) ≤ 3 times ULN; Total serum bilirubin ≤ 2 times ULN, unless the patient has a record of Gilbert syndrome; Bilirubin ≤ 3.0 times ULN and direct bilirubin Gilbert syndrome patients with hemoglobin ≤ 1.5 times ULN can be included; There must be a minimum level of lung reserve, with oxygen saturation greater than 95% in non oxygenated state.\n\nExclusion Criteria:\n\n* 1\\. Refractory lupus nephritis (LN):\n\n  1\\) Intracranial hypertension or cerebral consciousness disorders; 2) Symptomatic heart failure or severe arrhythmia; 3) Symptoms of severe respiratory failure; 4) Accompanied by other types of malignant tumors; 5) Diffuse intravascular coagulation; 6) Suffering from sepsis or other difficult to control infections; 7) Have uncontrollable diabetes and other endocrine diseases; 8) Serious mental disorder; 9) Head MRI examination shows obvious lesions in the skull; 10) Received organ transplantation (excluding bone marrow transplantation); 11) Female patients (those with fertility) have a positive HCG test in their blood; 12) Hepatitis (including hepatitis B and C), AIDS and syphilis screening positive persons; 13）eGFR CKD-EPI \\\u003C 30 ml\u002Fmin\u002F1.73m\\^2； 14) Any active skin disease that may interfere with the evaluation of systemic lupus erythematosus research,Including but not limited to psoriasis, dermatomyositis, systemic sclerosis, and non systemic diseases Skin manifestations of lupus erythematosus (such as skin vascular disease, pericapillary dilation)Zhang, fingertip sclerosis, rheumatoid nodules, erythema multiforme, leg ulcers)Or drug-induced lupus.\n\n  15\\) Subjects who were not successfully matched during the screening period; 16) Previously received CART treatment other than CD19-CART. 2. Primary Sjogren's syndrome with pulmonary hypertension (pSS PAH):\n\n  1\\) PH caused by other reasons: portal hypertension, hereditary hemorrhagic telangiectasia, etc; Congenital heart disease; Suspicious drugs and toxins; Chronic hypoxic disease-related pulmonary hypertension: moderate or severe obstructive pulmonary disease: FEV1\\\u003C55%； Moderate or severe restrictive lung disease: TLC\\\u003C60%； Chronic thromboembolic disease pulmonary hypertension: Pulmonary ventilation\u002Fperfusion imaging suggests moderate to high suspicion of pulmonary thromboembolism; 2) Suffering from severe active central nervous system (CNS) lupus, including seizures, psychosis, cerebrovascular accidents, or CNS vasculitis requiring therapeutic intervention within 60 days after baseline; 3) Dialysis patients or creatinine clearance rate less than 30mL\u002Fmin; 4) Pregnancy or breastfeeding; 5) Merge active infections (such as sepsis, bacteremia, mycosis, uncontrolled pulmonary infections, and active tuberculosis); 6) Hepatitis B surface antigen (HBsAg) and\u002For hepatitis B e antigen (HBeAg) are positive; Hepatitis B e antibody (HBe Ab) and\u002For hepatitis B core antibody (HBc Ab) are positive, and the number of HBV-DNA copies is greater than the measurable lower limit; Hepatitis C (HCV) antibody positive; Positive for human immunodeficiency virus (HIV) antibodies; Individuals who test positive for syphilis antibody (TP Ab); 7) Having undergone major surgeries evaluated by researchers as unsuitable for inclusion within the previous 4 weeks prior to screening; 8) Subjects who were not successfully matched during the screening period; 9) Previously received CART treatment other than CD19-CART. 3.Systemic sclerosis (SSc)：\n\n  1\\) Overlapping connective tissue diseases; Rheumatoid arthritis, systemic lupus erythematosus, or inflammatory myopathy 2) The clinical manifestations can be explained by similar diseases of SSc, such as nephrogenic systemic fibrosis, generalized scleroplakia, eosinophilic fasciitis, diabetes scleroma, scleromyedema, erythematous acrodynia, porphyria, sclerotic lichen, graft-versus-host disease, diabetes and other endocrine diseases related hand joint diseases.\n\n  3\\) Suffering from severe active central nervous system (CNS) lupus, including seizures, psychosis, cerebrovascular accidents, or CNS vasculitis requiring therapeutic intervention within 60 days after baseline; 4) Dialysis patients or creatinine clearance rate less than 30mL\u002Fmin; 5) Pregnancy or breastfeeding; 6) Merge active infections (such as sepsis, bacteremia, mycosis, uncontrolled pulmonary infections, and active tuberculosis); 7) Hepatitis B surface antigen (HBsAg) and\u002For hepatitis B e antigen (HBeAg) are positive; Hepatitis B e antibody (HBe Ab) and\u002For hepatitis B core antibody (HBc Ab) are positive, and the number of HBV-DNA copies is greater than the measurable lower limit; Hepatitis C (HCV) antibody positive; Positive for human immunodeficiency virus (HIV) antibodies; Individuals who test positive for syphilis antibody (TP Ab); 8) Having undergone major surgeries evaluated by researchers as unsuitable for inclusion within the previous 4 weeks prior to screening; 9) Subjects who were not successfully matched during the screening period; 10) Previously received CART treatment other than CD19-CART.","6 Years",{"count":51,"type":21},45,[24,53],"PHASE2","This is a single-center, open-label, non-randomized, single-arm clinical trial. Patients with refractory lupus neritis (SLE-LN), systemic sclerosis (SSc), and primary Sjogren syndrome combined with pulmonary artery hypertension (pSS-PAH receive umbilical cord blood CD19-BCMA CAR T cell therapy. The primary objective is to prospectively assess the safety of umbilical cord blood CD19BCMA CAR T cell therapy in patients with refractory lupus nephritis (SLE-LN), systemic sclerosis (SSc), and primaryjogren syndrome combined with pulmonary artery hypertension. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days after theusion of umbilical cord blood CD19-BCMA CAR T cells. It is anticipated that 45-54 participants will be recruited.",[28,56,57],"Systemic Sclerosis","Primary Sjogren's Syndrome Combined With Pulmonary Hypertension","2026-03-01",{"date":60,"type":33},"2026-03-03",{"date":62,"type":21},"2026-03-18",{"date":37,"type":21},{"name":65,"class":40},"Beijing GoBroad Hospital",{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":73,"maxAge":18,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":41},"100588903","phase-1-cd19-bcma-cart-cell-therapy-for-refractory-sle-ln-ssc-and-pss-pah-100588903","NCT06947460","CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH","CD19-BCMA CART Cell Therapy for Refractory Systemic Lupus Erythematosus Nephritis (SLE-LN), Systemic Sclerosis (SSc), and Primary Sjogren Syndrome Combined With Pulmonary Artery Hypertension (pSS-PAH): a Single-center, Open, Non-randomized, Single-arm Clinical Study","Inclusion Criteria 1. Refractory Lupus Nephritis（LN）: Patients who meet all the following requirements can be enrolled in the group.\n\nDefinition: Failure to achieve induction remission after 3 to 6 months of treatment with at least one immunosuppressive agent (including glucocorticoids, cyclophosphamide \\[CTX\\], tacrolimus, mycophenolate mofetil, and cyclosporine), accompanied by no reduction (or worsening) in proteinuria or persistent positive autoantibodies.\n\nDiagnostic criteria : According to the 2019 American College of Rheumatology (ACR) criteria, and confirmed by renal biopsy in accordance with the 2018 International Society of Nephrology (ISN)\u002FRenal Pathology Society (RPS) criteria (Appendix 3), were diagnosed with active, proliferative lupus nephritis (LN), including Class III or IV \\[excluding Class III (C), IV-S (C), and IV-G (C)\\], or combined Class III\u002FIV with Class V.\n\n1. Male or female, aged 10-65 years;\n2. Meeting the 2019 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) Classification Criteria for Systemic Lupus Erythematosus (Appendix 4);\n3. The ANA result is positive which means ANA titer≥ 1:80 (based on the equivalent detection results by Hep-2 immunofluorescence assay or enzyme immune assay), and\u002For according to the detection results from center laboratory, during the screening visit,the anti dsDNA serum antibody test is positive (based on ELISA assay, ≥30 IU\u002FmL);\n4. B cell CD19+ expression, and stop using immunosuppressant more than one week.\n5. The lymphocyte count in the subject's blood routine \\>0.5×109\u002FL, and no contraindications for cell collection;\n6. No serious allergic constitution;\n7. ECOG score: 0-2:\n8. Expected survival ≥90 days:\n\nSubjects and\u002For their guardian can understand and sign the informed consent form.\n\n2\\. SSc: Patients who meet all the following requirements can be enrolled in the group.\n\n1. Patients or their legal representatives sign the informed consent form;\n2. Male or female, aged 18-65 years.\n3. According to the SSc classification criteria proposed by American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR), chose the highest score under the same condition. If the score ≥9, it can be classified SSc. (Appendix 5)\n4. Satisfy a sufficient condition: the skin on the fingers of both hands is thickened and extend to the proximal end of metacarpophalangeal joint;\n5. The lymphocyte count in the subject's blood routine \\>0.5×109\u002FL, and no contraindications for cell collection.\n\n3\\. pSS-PAH: Patients who meet all the following requirements can be enrolled in the group.\n\n1. Patients or their legal representatives sign the informed consent form;\n2. Male or female, aged 18-65 years;\n3. Refractory connective tissue disease (PAH)patients:\n\n   a) Satisfy the 2002 AECG or 2016 ACR\u002F2016 EULAR classification criteria, can be diagnosed as pSS (Appendix 6); b) Confirmed by Right heart catheterization, satisfy the diagnose criteria of PAH: mPAP at rest ≥20mmHg; PAWP≤15mmHg; PVR at rest\\>2WUs.\n4. Low-risk patients whose PAH do not reach the risk stratification. The patients should meet: WHO cardiac function grading I-II; 6 minutes walking distance\\>440 m; BNP\\\u003C50ng\u002FL or NT-proBNP\\\u003C300ng\u002FL; RAP\\\u003C8mmHg and CI≥2.5 L·min-1·m-2;\n5. Subjects have received standard treatment in stable dose before first use of study drug, include: Glucocorticoids (prednisone 0-30mg\u002Fday, or other equivalent preparations) ≥4 weeks; Antimalarial drugs, single-agent immunosuppressants (MMF≤1.5g\u002Fday, AZP or 6-MP≤2mg\u002Fkg\u002Fday, MTX≤15mg\u002Fweek, Leflunomide ≤ 20mg\u002Fday) ≥12 weeks, and do not add or change in 24 weeks after drug treatment; Use PAH target drugs \\\u003C3 before drug treatment(PGAs, ETRA,PDE-5 inhibiter, GCCA), and stable at least 4 weeks, and do not add or change in 24 weeks after drug treatment;\n6. After clinician evaluate the disease condition of patients, they will allow using glucocorticoids no more than 10mg or other equivalent dose and stop all immunosuppressants (exclued hydroxychloroquine);\n7. Reproductive-aged female patients with negative blood human chorionic gonadotropin (HCG) test within 7 days before trial pre-conduct treatment; Any child-bearing male and female patients must agree to take effective contraceptive method during the process of study and within at least 1 year after cell infusion. Child-bearing patients refer that he or she has the biological ability to born alive baby and have normal sex life. Female patients without the ability of born: hysterectomy or ovariectomy, or medically confirmed ovarian failure, or medically confirmed postmenopausal (without pathological or biological reason, amenorrhea last for at least 12 months);\n8. Have appropriate organ function, the criteria are as follows:\n\n   a) AST≤3 times upper limit of normal (ULN); b) ALT ≤3 times ULN; c) T-Bil ≤2 times ULN, unless the patient has a record of Gilbert syndrome; Patients with Gilbert syndrome can be enrolled satisfied the condition of Bil≤3 times ULN and DBIl ≤1.5 times ULN; d) Must have the lowest level of lung reserve, oxygen saturation under non-oxygen inhalation state \\>95%; e) The lymphocyte count in the subject's blood routine \\>0.5×109\u002FL, and no contraindications for cell collection.\n\n4.AID Definition: Based on the reliable laboratory test, it is confirmed that one or more definite disease-related antibodies in serum are positive, laboratory results and clinical symptoms have reasonable association. Including systemic lupus erythematosus, sjogren's syndrome, systemic sclerosis, rheumatoid arthritis, connective tissue diseases, overlap syndrome, etc. At the same time exclude other etiology may cause similar symptoms and signs, infections, malignant tumors, metabolic diseases, primary organ failure, etc.\n\n1. Male or female, aged 10-65 years; Patients who do not meet the inclusive criteria of three groups above, meet any one below can be enrolled.\n2. ANA titer\\\u003C1:80 (based on the equivalent detection results by Hep-2 immunofluorescence assay or enzyme immune assay), and\u002For during the screening visit, by the detection results from center laboratory, anti dsDNA serum antibody test is negative (based on ELISA assay, \\\u003C30 IU\u002FmL);\n3. In conventional therapy, occur recurrent infections, leading to intolerance of conventional therapy, but no active infection, serious infection(tuberculosis) currently;\n4. Patients who cannot use drugs anymore, because of bone infarction, osteonecrosis, severe bone pain caused by long term use of drugs.\n5. Patients who cannot use drugs anymore, because of vision changes, retinopathy, fundus hemorrhage caused by long term use of drugs.\n6. Patients who cannot use drugs anymore, because of endocrine-related changes (premature closure of the femoral shaft, severe obesity, diabetes, impact on growth and development, etc.) caused by long term use of drugs.\n7. Severe toxicity of blood system (≥grade3; neutrophil\\\u003C1\\*10\\^9\u002FL,platelet\\\u003C50\\*10\\^9\u002FL,hemoglobin\\\u003C80g\u002FL);\n8. Abnormal liver function (ALT ≥3 times ULN; ALT≥3 times ULN; T-Bil ≥2 times ULN);\n9. After 3 months of regular treatment, there are still have disease progression (eg. urine protein index increased by 3 times);\n10. Previously received CAR-T therapies, there are still have disease progression.\n\nExclusion criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1\\. Refractory Lupus Nephritis (LN):\n\n1. Intracranial hypertension or disorder of consciousness;\n2. Symptomatic heart failure or severe arrhythmia;\n3. Symptoms of severe respiratory failure;\n4. Complicated with other types of malignant tumors;\n5. Diffuse intravascular coagulation;\n6. Suffering from septicemia or other uncontrollable infections;\n7. Patients with uncontrollable diabetes and other endocrine diseases;\n8. Severe mental disorders;\n9. Obvious and active intracranial lesions were detected by cranial magnetic resonance imaging (MRI);\n10. Have received organ transplantation (excluding bone marrow transplant);\n11. Reproductive-aged female patients with positive blood human chorionic gonadotropin (HCG) test;\n12. Positive screening for hepatitis (HBV and HCV included), HIV and syphilis;\n13. The subject is unable to undergo PBMC collection, nor are there cryopreserved PBMCs available for CAR-T cell manufacturing;\n14. eGFR CKD-EPI \\\u003C 30 ml\u002Fmin\u002F1.73m\\^2;\n15. Any active skin disease that may interfere with the assessment of systemic lupus erythematosus (SLE) research, including but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-SLE cutaneous manifestations (e.g., cutaneous vasculopathy, perivascular telangiectasia, sclerodactyly, rheumatoid nodules, erythema multiforme, leg ulcers), or drug-induced lupus;\n16. Previously received other CAR-T therapies except CD19-CART.\n\n2.SSc\n\n1. Other connective tissue disease: Rheumatoid Arthritis, System Lupus or Inflammatory Myopathies;\n2. Clinical manifestations can be explained by disease similar to SSc: hand joint lesions related to nephrogenic systemic fibrosis, generalized morphea, eosinophilic fasciitis, diabetic scleredema, scleromyxedema, erythromelalgia, porphyria, lichen sclerosus, graft-versus-host disease, diabetes mellitus, and other endocrine and metabolic diseases;\n3. Patients who have severe active central nervous system (CNS) lupus, including epileptic seizures, pyschosis, cerebrovascular accident or CNS vasculitis requiring treatment intervention within 60 days after baseline;\n4. Dialysis patients or Ccr \\\u003C30ml\u002Fmin;\n5. Pregnant or suckling period;\n6. Combined with active infection (eg. septicemia, bacteremia, fungemia, uncontrolled pulmonary infection, and active tuberculosis);\n7. Detection positive: HBsAg, HbeAg; HBe-Ab, HBc-Ab (the copy number of HBV-DNA is greater than the measurable low limit); HCV-Ab, HIV-Ab, TP-Ab;\n8. Patients have undergone big surgeries which evaluated by investigators as unsuitable for enrollment within 4 weeks before screening;\n9. Previously received other CAR-T therapies except CD19-CART.\n\n3.pSS-PAH\n\n1. PH caused by other reasons: Portal hypertension, hereditary hemorrhagic telangiectasia, etc.; congenital heart disease; suspected drugs and toxicants; pulmonary hypertension related to chronic hypoxic diseases: moderate or severe obstructive pulmonary disease: FEV1 \\\u003C 55%; moderate or severe restrictive pulmonary disease: TLC \\\u003C 60%; pulmonary hypertension due to chronic thromboembolic disease: pulmonary ventilation\u002Fperfusion imaging suggests moderate or high suspicion of pulmonary thromboembolism;\n2. Patients who have severe active central nervous system (CNS) lupus, including epileptic seizures, pyschosis, cerebrovascular accident or CNS vasculitis requiring treatment intervention within 60 days after baseline;\n3. Dialysis patients or Ccr \\\u003C30ml\u002Fmin;\n4. Pregnant or suckling period;\n5. Combined with active infection (eg. septicemia, bacteremia, fungemia, uncontrolled pulmonary infection, and active tuberculosis).\n6. Detection positive: HBsAg, HbeAg; HBe-Ab, HBc-Ab (the copy number of HBV-DNA is greater than the measurable low limit); HCV-Ab, HIV-Ab, TP-Ab;\n7. Patients have undergone big surgeries which evaluated by investigators as unsuitable for enrollment within 4 weeks before screening;\n8. Previously received other CAR-T therapies except CD19-CART.\n\n6\\) Detection positive: HBsAg, HbeAg; HBe-Ab, HBc-Ab (the copy number of HBV-DNA is greater than the measurable low limit); HCV-Ab, HIV-Ab, TP-Ab; 7) Patients have undergone big surgeries which evaluated by investigators as unsuitable for enrollment within 4 weeks before screening; 8) Previously received other CAR-T therapies except CD19-CART. 4. AID\n\n1. Intracranial hypertension or disorder of consciousness;\n2. Symptomatic heart failure or severe arrhythmia;\n3. Symptoms of severe respiratory failure;\n4. Complicated with other types of malignant tumors;\n5. Diffuse intravascular coagulation;\n6. Suffering from septicemia or other uncontrollable infections;\n7. Patients with uncontrollable diabetes and other endocrine diseases;\n8. Severe mental disorders;\n9. Obvious and active intracranial lesions were detected by cranial magnetic resonance imaging (MRI);\n10. Have received organ transplantation (excluding bone marrow transplant);\n11. Reproductive-aged female patients with positive blood human chorionic gonadotropin (HCG) test;\n12. Positive screening for hepatitis (HBV and HCV included), HIV and syphilis;\n13. The subject is unable to undergo PBMC collection, nor are there cryopreserved PBMCs available for CAR-T cell manufacturing;\n14. eGFR CKD-EPI \\\u003C 30 ml\u002Fmin\u002F1.73m\\^2.","10 Years",{"count":51,"type":21},[24,53],"This is a single-center, open-label, non-randomized, single-arm clinical trial. Patients with refractory lupus neritis (SLE-LN), systemic sclerosis (SSc), and primary Sjogren syndrome combined with pulmonary artery hypertension (pSS-PAH) receive CD19-BCMA CAR T cell therapy. The primary objective is to prospectively assess the safety of CD19-BCMA CAR T cell therapy in patients with SLE-LN, SSc, and pSS-PAH. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days after CD19-BCMA CAR T cell infusion.",[28,56,57],"2026-02-27",{"date":60,"type":33},{"date":81,"type":33},"2025-04-18",{"date":83,"type":21},"2026-07-31",{"name":65,"class":40},{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":41},"100623942","a-long-term-follow-up-study-for-participants-previously-treated-with-kyv-101-100623942","NCT07403188","A Long-Term Follow-Up Study for Participants Previously Treated With KYV-101","KYSA-4","Inclusion Criteria:\n\n* Provided informed consent for the LTFU study\n* Received at least 1 infusion of KYV-101 as part of a previous KYV-101 parent treatment protocol\n\nExclusion Criteria:\n\n* Not applicable",{"count":93,"type":21},70,"OBSERVATIONAL","The purpose of this long-term follow-up (LTFU) study is to collect delayed adverse events (AEs) and understand the persistence of KYV-101 (autologous CAR T cell product; gene-modified product), in participants who have been administered KYV-101 (gene-modified product; autologous CAR T cell product).\n\nThis LTFU protocol will be open to any participant who received at least one infusion of KYV-101 in a previous Kyverna sponsored clinical trial or Investigator Initiated Trial (IIT).",[28,97,98,99,100,101,102],"Myasthaenia Gravis","Stiff Person Syndrome","Rheumatoid Arthritis (RA)","Multiple Sclerosis","Dermatomyositis","Systemic Sclerosis (SSc)","2026-02-03",{"date":105,"type":33},"2026-02-11",{"date":107,"type":33},"2025-11-24",{"date":109,"type":21},"2041-01",{"name":111,"class":112},"Kyverna Therapeutics","INDUSTRY"]