[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"antiphospholipid-syndrome-aps\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:antiphospholipid-syndrome-aps":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,42,72,101,120,145,180,205,243,264,294,322],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100640282","phase-2-anifrolumab-in-adults-with-primary-antiphospholipid-syndrome-anifaps-trial-100640282",false,"NCT07584083","Anifrolumab in Adults With Primary Antiphospholipid Syndrome (AnifAPS Trial)","A Phase II Open-Label Pilot Trial Assessing the Safety of Anifrolumab in Adult Patients With Primary Antiphospholipid Syndrome (APS). The AnifAPS Trial","AnifAPS","Inclusion Criteria:\n\n1. Provision of written informed consent (ICF) prior to any study-specific procedures.\n2. Females\u002Fmales aged 18 to 70 years at Screening (at the time of ICF signing).\n3. Weight ≥40.0 kg at Screening.\n4. Classified as having primary APS as per the 2023 ACR\u002FEULAR APS classification criteria, i.e. fulfilling at least one documented clinical criterion \\[ie., macrovascular (venous thromboembolism and\u002For arterial thrombosis), established microvascular (livedoid vasculopathy, aPL nephropathy, pulmonary haemorrhage or myocardial disease), cardiac valve (valve thickening or valve vegetation) and\u002For haematology (thrombocytopenia)\\] and at least one laboratory criterion and scoring at least three points in each of the clinical and laboratory domains.\n\n   Note: Patients with obstetric manifestations will be excluded from this study.\n5. For females of childbearing potential only: Negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test at Screening.\n6. Females of childbearing potential must be willing to use a highly effective method of contraception (failure rate of \\\u003C1% per year when used consistently and correctly) throughout their participation in the study, i.e., from Screening and for up to 20 weeks after the last dose of IP. Examples of highly effective methods of contraception are located in Appendix C, Contraceptive and Barrier Guidance.\n7. Male patients who are sexually active with a female partner of childbearing potential must be willing to use a condom (with spermicide where commercially available) throughout their participation in the study, i.e., from Screening and for up to 20 weeks after the last dose of IP.\n8. Male patients must not donate sperm during the course of the study and for up to 20 weeks after the last dose of the IP.\n9. Meeting all the following TB criteria:\n\n   1. No history of latent or active TB prior to Screening, except for latent TB with documented completion of appropriate treatment as per local SoC Note: Subjects with no history of latent TB prior to the initial Screening visit, but who are diagnosed with latent TB during the Screening Period, may be considered eligible if appropriate treatment is initiated prior to first administration of IP as per local SoC. Such subjects may be re-screened if necessary to allow for local guidelines on latent TB treatment initiation.\n   2. No signs or symptoms suggestive of active TB from medical history or physical examination\n   3. No recent contact with a person with active TB OR if there has been such contact, referral to a physician specialising in TB to undergo additional evaluation prior to first administration of IP (documented appropriately in source), and, if warranted, receipt of appropriate treatment for latent TB at or prior to first administration of IP as per local SoC.\n   4. Must meet 1 of the following criteria:\n\n   (i)Negative QuantiFERON-TB Gold (QFT-G) test result for TB obtained within 4 weeks prior to Week 0 (Day 1) OR (ii)Positive QFT-G test result for TB obtained during the Screening Period for which active TB has been ruled out and appropriate treatment for latent TB has been initiated prior to first administration of IP as per local SoC OR (iii)Indeterminate (confirmed on retest) QFT-G test result for TB obtained during the Screening Period with ongoing QFT-G testing for TB as clinically indicated.\n10. Chest x-ray \\[or lung CT\\*, where available\\] with no evidence of current active infection (eg, TB) or previous old active TB, malignancy, or clinically significant abnormalities (unless due to APS) obtained during the Screening Period or anytime within 12 weeks prior to signing the ICF.\n11. Negative SARs-CoV-2 polymerase chain reaction (PCR) or antigen test result as per local policies at Screening.\n12. Females with an intact cervix must have documentation of a normal Pap smear with no documented malignancy (e.g., cervical intraepithelial neoplasia grade III \\[CIN III\\], carcinoma in situ \\[CIS\\], or adenocarcinoma in situ \\[AIS\\]) within 2 years prior to Week 0 (Day 1) (see Appendix E for guidance on abnormal Pap smear results).\n\nNote: Any abnormal Pap smear result documented within 2 years prior to randomisation must be repeated to confirm patient eligibility. See also Exclusion criterion 23b.\n\nExclusion Criteria:\n\n* General exclusion criteria:\n\n  1. Any condition that, in the opinion of the Investigator, would interfere with the efficacy or safety evaluation of the study intervention or put the participant at safety risk.\n  2. Involvement in the planning and\u002For conduct of the study (applies to both Investigator staff and\u002For staff at the study site).\n  3. Current participation in another clinical study with an IP.\n  4. Lactating or pregnant females or females who intend to become pregnant anytime from initiation of Screening through the Safety Follow-up Period (12 weeks following last dose of IP).\n  5. Current alcohol, drug or chemical abuse, or a history of such abuse within 12 months prior to Week 0 (Day 1).\n  6. Major surgery within 8 weeks prior to Screening or elective major surgery planned anytime from initiation of Screening through the Safety Follow-up Period (12 weeks following last dose of IP).\n  7. Spontaneous or induced abortion, still or live birth, or pregnancy ≤4 weeks prior to Screening.\n  8. Any of the following laboratory abnormalities at Screening (within 4 weeks prior to Week 0 \\[Day 1\\]):\n\n     * aspartate aminotransferase (AST) \\>2.5 x upper limit of normal (ULN)\n     * alanine aminotransferase (ALT) \\>2.0 x ULN\n     * total bilirubin \\> ULN (unless due to Gilbert's syndrome)\n     * serum creatinine \\>2.5 mg\u002FdL (or \\>181 μmol\u002FL)\n     * urine protein\u002Fcreatinine ratio (UACR) \\>2.0 mg\u002Fmg (or \\>226.30 mg\u002Fmmol)\n     * neutrophil count \\\u003C1000\u002FμL (or \\\u003C1.0 x 109\u002FL)\n     * PLT \\\u003C25000\u002F μL (or \\\u003C25 x 109\u002FL)\n     * haemoglobin \\\u003C8 g\u002FdL (or \\\u003C80 g\u002FL)\n     * glycosylated haemoglobin (HbA1c) \\>8% (or \\>0.08) for diabetic subjects only Note: Abnormal screening laboratory tests may be repeated once on a separate sample before the subject is declared a screen failure.\n  9. Major surgery within 8 weeks prior to Screening or elective major surgery planned anytime from initiation of Screening through the Safety Follow-up Period (12 weeks following last dose of IP).\n\n     Exclusion criteria related to APS and\u002For other medical conditions\u002Fdiseases:\n  10. Meeting ACR\u002FEULAR classification criteria for SLE or other systemic autoimmune diseases.\n  11. History or current diagnosis of catastrophic APS within 12 months prior to Screening.\n  12. Any medical or psychiatric condition (including severe or unstable neuropsychiatric APS) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study.\n  13. Current evidence of moderately severe depression as indicated by a score ≥15 in the PHQ-9 questionnaire at Screening.\n  14. Known history of suicidal behaviour in the past 12 months prior to Screening or current evidence of suicidal ideation as indicated by a positive response (i.e., selecting 1: \"Several days\", 2: \"More than half the days\" or 3: \"Nearly every day\") to Question 9 of the PHQ-9 questionnaire irrespective of total score at Screening.\n\n      Exclusion criteria related to infection and malignancy risk factors:\n  15. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the subject to infection or a positive result for humanimmunodeficiency virus (HIV) antibody or infection confirmed by the local laboratory at Screening.\n\n      Note: An HIV test must be performed during the Screening Period, and the result should be available prior to Week 0 (Day 1). Patients refusing to perform HIV testing during the Screening Period will be excluded from study participation.\n  16. Confirmed seropositivity for hepatitis B at Screening, i.e.:\n\n      1. Positive result for hepatitis B surface antigen (HBsAg), OR\n      2. Positive result for hepatitis B core antibody (HBcAb) AND hepatitis B virus (HBV) DNA detected above the lower limit of quantification (LLQ) by reflex testing by the local laboratory.\n\n      Note: Patients who are HBcAb-positive at Screening will be tested every 3 months for HBV DNA. To remain eligible for the study, the patient's HBV DNA levels must remain below the LLQ as per the local laboratory.\n  17. Positive result for hepatitis C antibody at Screening.\n  18. Any severe herpes zoster infection at any time prior to Week 0 (Day 1), including but not limited to, non-cutaneous herpes (ever), herpes encephalitis (ever), recurrent herpes zoster (defined as 2 episodes within 2 years) or ophthalmic herpes involving the retina (ever).\n  19. Any herpes zoster, cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection that has not completely resolved within 12 weeks prior to Screening.\n  20. Any history of severe COVID-19 infection or any prior COVID-19 infection with documented long-COVID and\u002For clinically significant unresolved sequelae within 12 months prior to Week 0 (Day 1) or mild\u002Fasymptomatic acute COVID-19 infection (lab confirmed or suspected based on clinical signs\u002Fsymptoms) within 6 weeks prior to Week 0 (Day 1).\n  21. Any opportunistic infection requiring hospitalisation or treatment with IV antibiotics within 3 years prior to Screening.\n  22. Any of the following:\n\n      1. Clinically significant chronic infection (e.g. osteomyelitis, bronchiectasis, etc.) within 8 weeks prior to Week 0 (Day 1) (chronic nail infections are allowed)\n      2. Any infection requiring hospitalization or treatment with IV antibiotics not completed at least 4 weeks prior to Week 0 (Day 1)\n  23. Any infection requiring oral antibiotics (including antivirals) within 2 weeks prior to Week 0 (Day 1).\n  24. History of malignancy except for:\n\n      1. squamous or basal cell carcinoma of the skin with documented success of curative therapy of ≥3 months prior to Week 0 (Day 1), OR\n      2. cervical cancer in situ (CIS) treated with documented success of curative therapy ≥12 months prior to Week 0 (Day 1)\n\n      Exclusion criteria related to prior\u002Fconcomitant medications:\n  25. Currently receiving direct oral anticoagulants (DOACs).\n  26. Prior treatment with any of the following:\n\n      * anifrolumab\n      * any investigational product (small molecule or biologic agent) within 90 days or 5 half-lives prior to Screening, whichever is greater\n      * any commercially available biologic agent, including but not limited to B-cell depleting therapies \\[i.e. rituximab, other anti-CD20, anti-CD22 or anti-CD38 agents\\], anti-TNF-α agents, belimumab, abatacept or any other, within 90 days or 5 half-lives prior to Screening, whichever is greater\n      * any commercially available protein kinase inhibitor including but not limited to Janus kinase (JAK) inhibitors or Bruton's tyrosine kinase (BTK) inhibitors within 90 days or 5 half-lives prior to Screening, whichever is greater\n      * conventional immunomodulators or immunosuppressants (e.g., cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, etc.) or IV immunoglobulin within 90 days prior to Screening\n      * intraarticular, intramuscular, or intravenous corticosteroids within 30 days prior to Screening.\n      * any live or attenuated vaccine within 8 weeks prior to Screening.\n  27. Current treatment with oral corticosteroids except for patients with severe thrombocytopenia or pulmonary haemorrhage who have started oral corticosteroids (up to 40 mg\u002Fday prednisone or equivalent) within 30 days Week 0 (Day 1).\n  28. Blood transfusion or receipt of blood products within 4 weeks prior to Screening.\n  29. Known history of allergy or reaction to any component of the IP formulation or history of anaphylaxis to any human gamma globulin therapy.\n\nFor procedures for withdrawal of incorrectly enrolled subjects, see Section 3.4.","ALL","18 Years","70 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a phase II, single-centre, open-label pilot study evaluating the safety and tolerability of anifrolumab in adult patients with primary antiphospholipid syndrome (APS). Approximately 20 participants will receive 120 mg subcutaneous anifrolumab once weekly for up to 52 weeks in addition to their standard of care treatment.\n\nThe primary objective is to assess the incidence of adverse events during treatment. Secondary and exploratory objectives include evaluation of immunological parameters, thromboinflammatory markers, and patient-reported outcomes. Participants will be followed for an additional 12-week safety follow-up period after completion of treatment.",[28],"Antiphospholipid Syndrome (APS)","RECRUITING","2026-05-30",{"date":32,"type":33},"2026-06-02","ACTUAL",{"date":35,"type":33},"2026-04-29",{"date":37,"type":22},"2028-06",{"name":39,"class":40},"National and Kapodistrian University of Athens","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100544632","phase-1-phase-1b-trial-of-ray121-in-immunological-diseases-rainbow-trial-100544632","NCT06371417","Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)","Phase 1b Open-label Basket Trial of RAY121 to Inhibit Classical Complement Pathway in Immunological Diseases (RAINBOW Trial)","Inclusion Criteria:\n\n1. Signed informed consent form\n2. Age \\>= 18 and \\\u003C=75 at the time of signing informed consent form (except for BP; Age \\>=18 and \\\u003C= 85 with Karnofsky score \\>= 60% at screening)\n3. Ability to comply with the study protocol\n4. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods\n5. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm\n6. APS cohort: Established primary APS defined by the following criteria (at least one of the laboratory criteria and one of the clinical criteria must be met):\n\n   * Laboratory criteria (aPL profile)\n\n     * Persistently positive lupus anticoagulant (LA) test\n     * Persistently positive anticardiolipin (aCL) immunoglobulin G (IgG) isotype\n     * Persistently positive anti-beta-2 glycoprotein-1 (aβ2GPI) IgG isotype\n   * Clinical criteria\n\n     * Livedoid vasculopathy and presence of skin ulcer\n     * Acute\u002Fchronic aPL nephropathy\n7. BP cohort:\n\n   * 1\\) Age \\>= 18 and \\\u003C= 85 with Karnofsky score \\>= 60 %\n   * 2\\) Predominant cutaneous lesions\n   * 3\\) Diagnosis with BP with following assessments positive:\n   * a Positive direct immunofluorescence, and either\n   * b Positive indirect immunofluorescence, or\n   * c Positive serology on ELISA for BP180 autoantibody\n   * 4\\) Bullous Pemphigoid Disease Area Index (BPDAI) score \\>= 20\n   * 5\\) Weekly average of daily Peak Pruritus Numerical Rating Score (PP-NRS) \\>=4\n   * 6\\) Accept to take photograph of bullous lesions\n8. BS cohort:\n\n   * 1\\) Diagnosed with BS\n   * 2\\) Oral ulcers that occurred at least 3 times in the previous 12 month period\n   * 3\\) Have at least 2 oral ulcers over the 4 weeks prior to screening\n   * 4\\) Have at least 2 oral ulcers at Week 0\n   * 5\\) Have prior treatment with at least 1 non-biologic BS therapy\n   * 6\\) Patients who need systemic therapy as whose oral or mucocutaneous ulcers cannot be adequately controlled by topical therapy\n9. DM cohort:\n\n   * 1\\) Diagnosed with definite or probable inflammatory myopathies and categorized as DM\n   * 2\\) Patients with inadequate response to corticosteroids and\u002For immune-suppressants or intolerance to DM therapies\n   * 3\\) Manual Muscle Test-8 (MMT-8) score \\\u003C 142, with at least one abnormality in the following Core Set Measures:\n\n     * Patient Global Activity Visual Analogue Scale (PtGA-VAS) \\>= 2 cm\n     * Physician Global Activity Visual Analogue Scale (PhGA-VAS) \\>= 2 cm\n     * Global extra-muscular activity \\>= 2 cm\n     * At least one muscle enzyme \\> 1.5 times upper limit of normal (ULN)\n     * Health Assessment Questionnaire (HAQ) \\>= 0.25\n   * 4\\) Moderate to severe DM defined as CDASI activity score \\> 14\n10. IMNM cohort:\n\n    * 1\\) Clinically Diagnosed with IMNM as anti-HMGCR myopathy or anti-SRP myopathy\n    * 2\\) Creatine kinase (CK) \\> 1,000 U\u002FL\n    * 3\\) Patients who have an inadequate response to corticosteroids and\u002For immunosuppressants or intolerance to IMNM therapies\n    * 4\\) MMT-8 score \\\u003C 142\n11. ITP cohort:\n\n    * 1\\) Confirmed diagnosis of persistent\u002Fchronic ITP based on the following criteria:\n\n      * ITP defined per the current guidelines\n      * Platelet count \\\u003C= 30 × 10\\^9\u002FL on 2 consecutive occasions\n    * 2\\) Lack of an sustained adequate platelet count response to a thrombopoietin receptor agonist and at least one other ITP treatment or a second thrombopoietin receptor agonist (TPO-RA)\n    * 3\\) A history of response with an platelet counts increase more than 20 × 10\\^9\u002FL from baseline by at least one prior line of therapy\n\nExclusion Criteria:\n\n1. History of anaphylaxis or hypersensitivity to a biologic agent\n2. Active infection requiring systemic antiviral, antibiotics or antifungal\n3. Planned surgery during the study\n4. Pregnant or breastfeeding, or intending to become pregnant\n5. Any serious medical condition or abnormality in clinical laboratory tests that precludes the patient's safe participation in and completion of the study\n6. Clinically significant ECG abnormalities\n7. Illicit drug or alcohol abuse\n8. Clinical diagnosis of autoimmune diseases other than the target disease (except for Sjögren's syndrome in DM and IMNM)\n9. Positive for hepatitis B surface antigen\n10. Positive for hepatitis C virus antibody\n11. Positive for human immunodeficiency virus antibody\n12. Evidence of current infection with tuberculosis\n13. History of cancer within 5 years\n14. Treatment with investigational therapy within 28 days or 5 half-lives\n15. Previous and current treatment with anti-C1s antibody at any time\n16. Other complement inhibitors within 3 months\n17. Patients who receive any treatments which fall into the Prohibited Therapy Criteria\n18. Patients with an elevated alanine aminotransferase or aspartate aminotransferase \\> 1.5 × ULN in combination with an elevated total bilirubin \\> 1.5 × ULN\n19. APS cohort:\n\n    * 1\\) APS associated with other systemic autoimmune disease\n    * 2\\) Acute thrombosis (arterial or venous acute thrombosis diagnosis) within 30 days before screening\n    * 3\\) Patients with thrombotic APS without any anticoagulation treatment\n    * 4\\) Treatment with prohibited medications\n20. BP cohort:\n\n    * 1\\) Initiation of treatment with or increase in the dose of systemic or topical corticosteroid within 2 weeks\n    * 2\\) Current treatment with a drug that may cause or exacerbate BP unless the dose has been stable\n    * 3\\) Initiation of treatment with topical calcineurin inhibitor, or topical phosphodiesterase (PDE) 4 inhibitor within 7 days\n    * 4\\) Treatment with prohibited medications\n21. BS cohort:\n\n    * 1\\) BS-related active major organ involvement-ocular lesions requiring immunosuppressive therapy, pulmonary (e.g., pulmonary artery aneurysm), vascular (e.g., thrombophlebitis), gastrointestinal (e.g., ulcers along the gastrointestinal tract), and central nervous systems (e.g., meningoencephalitis) manifestations\n    * 2\\) History of venous or arterial thrombosis within 1 year\n    * 3\\) Treatment with prohibited medications\n22. DM cohort:\n\n    * 1\\) PhGA-VAS improvement \\>= 3, or clinically relevant improvement between screening and baseline\n    * 2\\) Overlap myositis (except for overlap with Sjögren's syndrome), connective tissue disease associated DM, inclusion body myositis, polymyositis, IMNM, juvenile DM or drug-induced myopathy\n    * 3\\) Cancer-associated myositis\n    * 4\\) Significant muscle damage\n    * 5\\) Past history of severe Interstitial lung disease flare, severe non-infectious lung inflammation which required active intervention, or multiple episodes of lung disease\n    * 6\\) Severe respiratory muscle weakness\n    * 7\\) Severe bulbar palsy\n    * 8\\) Treatment with prohibited medications\n23. IMNM cohort:\n\n    * 1\\) PhGA-VAS improvement \\>= 3, or clinically relevant improvement between screening and baseline\n    * 2\\) Overlap myositis (except for overlap with Sjögren's syndrome), connective tissue disease associated DM, inclusion body myositis, polymyositis, juvenile DM or druginduced myopathy\n    * 3\\) Cancer-associated myositis\n    * 4\\) Significant muscle damage\n    * 5\\) Past history of severe Interstitial lung disease (ILD) flare, severe non-infectious lung inflammation which required active intervention, or multiple episodes of lung disease\n    * 6\\) Severe respiratory muscle weakness\n    * 7\\) Severe bulbar palsy\n    * 8\\) Treatment with prohibited medications\n24. ITP cohort:\n\n    * 1\\) Secondary ITP\n    * 2\\) Clinical diagnosis or history of Myelodysplastic Syndrome or autoimmune hemolytic anemia\n    * 3\\) History of venous or arterial thrombosis within 12 months\n    * 4\\) Patients who experienced major bleeding within 4 weeks\n    * 5\\) Treatment with prohibited medications\n    * 6\\) Any laboratory test results meet either of the following criteria at screening:\n\n      * Hemoglobin \\\u003C10 g\u002FdL\n      * Thyroid-stimulating hormone \\>= 10 μIU\u002FmL","85 Years",{"count":51,"type":22},144,[53],"PHASE1","This Phase 1b basket trial will investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of RAY121, a inhibitor of classical complement pathway, after multiple dose administration in patients with immunological diseases such as antiphospholipid syndrome (APS), bullous pemphigoid (BP), Behçet's Syndrome (BS), dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM) and immune thrombocytopenia (ITP).",[28,56,57,58,59,60],"Bullous Pemphigoid (BP)","Behçet's Syndrome (BS)","Dermatomyositis (DM)","Immune-mediated Necrotizing Myopathy (IMNM)","Immune Thrombocytopenia (ITP)","2026-04-01",{"date":63,"type":33},"2026-04-02",{"date":65,"type":33},"2024-08-19",{"date":67,"type":22},"2026-06-30",{"name":69,"class":70},"Chugai Pharmaceutical","INDUSTRY",69,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":82,"briefSummary":83,"conditions":84,"keywords":90,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":41},"100602439","phase-1-a-clinical-study-of-yts109-cells-for-the-treatment-of-rr-autoimmune-diseases-100602439","NCT07123519","A Clinical Study of YTS109 Cells for the Treatment of R\u002FR Autoimmune Diseases","An Exploratory Clinical Study of YTS109 Cell in Subjects With Relapsed\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\nSubjects must meet both the following common inclusion criteria and disease-specific inclusion criteria simultaneously to be eligible for participation in this study:\n\n* Common inclusion criteria:\n\n  1. Age ranges from 18 to 65 years old (including threshold), regardless of gender.\n  2. Essential Organ Function Criteria:\n\n     2.1 Bone marrow: Neutrophils ≥1×10\\^9\u002FL (within 2 weeks, excluding granulocyte colony-stimulating factor use); Hemoglobin ≥60 g\u002FL.\n\n     2.2 Liver: ALT\u002FAST ≤3×ULN (disease-related elevations permitted). TBIL≤1.5×ULN (disease-related elevations permitted).\n\n     2.3 Renal: CrCl≥30mL\u002Fmin (Cockcroft-Gault formula, excluding acute declines). 2.4 Coagulation: INR\u002FPT ≤1.5×ULN. 2.5 Cardiovascular: Hemodynamic stability.\n  3. Fertile females or males with partners of childbearing age must use medically approved contraception or abstain during and ≥12 months post- treatment. Negative serum HCG test (within 7 days pre-enrollment) for fertile females; non-lactating.\n  4. Voluntary participation with signed informed consent and compliance.\n* Specific inclusion criteria:\n\n  1. Relapsing and refractory systemic lupus erythematosus:\n\n     1.1 Meeting the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for systemic lupus erythematosus (SLE); 1.2 Meeting the criteria for refractory lupus nephritis (LN) or SLE-associated immune thrombocytopenia (SLE-ITP), defined as follows: 1.2.1 Refractory Lupus Nephritis:(1)Failure to achieve remission following treatment regimens comprising glucocorticoids and at least two immunosuppressive agents (including cyclophosphamide \\[CTX\\], tacrolimus, mycophenolate mofetil \\[MMF\\], and cyclosporine) and\u002For biologic agents (including rituximab, belimumab, telitacicept, etc.). (2)Urine protein-to-creatinine ratio (UPCR) ≥1.0 g\u002Fg or 24-hour urine protein excretion \\>1.0 g at screening. (3)Renal pathology must be performed within 6 months prior to the screening visit or during the screening period, demonstrating proliferative lupus nephritis (Class III or IV, with or without Class V) according to the 2003 International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) criteria, with ≤50% glomerular sclerosis noted in the pathology report.\n\n     1.2.2 Refractory SLE-Associated Immune Thrombocytopenia: Failure to achieve partial remission after at least one course of methylprednisolone pulse therapy (0.5-1 g × 3-5 days) or high-dose glucocorticoids (equivalent to 1 mg\u002Fkg\u002Fday of prednisone) combined with one or more immunosuppressive agents (including biologic agents) for at least 3 months, or inability to maintain therapeutic efficacy during glucocorticoid tapering. Platelet count \\\u003C50 × 10⁹\u002FL on at least two consecutive complete blood count tests prior to enrollment. Exclusion of thrombocytopenia due to non-SLE causes, such as infection, bone marrow suppression, or hypersplenism.\n  2. Relapsing and refractory Sjögren's syndrome:\n\n     2.1. Meeting the 2002 American-European Consensus Group (AECG) criteria or the 2016 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) classification criteria for primary Sjögren's syndrome; 2.2 Having a disease activity score of EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) ≥ 6; 2.3 Testing positive for anti-SSA\u002FRo antibodies; 2.4 Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids in combination with any of the following immunosuppressive agents or biological agents: cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.\n  3. Relapsing and refractory Sjogren's Syndrome:\n\n     3.1 Meeting the 2013 American College of Rheumatology (ACR) classification criteria for systemic sclerosis; 3.2 Testing positive for systemic sclerosis-related antibodies; 3.3 Presenting with diffuse cutaneous sclerosis or active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT); 3.4 Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.; 3.5 Definition of progressive condition: Demonstrating rapid skin progression (an increase in modified Rodnan skin score, mRSS, of \\>25%) or pulmonary disease progression (a 10% decrease in forced vital capacity, FVC, or a \\>5% decrease in FVC accompanied by a 15% decrease in diffusion capacity for carbon monoxide, DLCO).\n\n     Note: Meeting either criterion 4 or 5 is sufficient.\n  4. Relapsing and refractory Inflammatory Myopathy:\n\n     4.1 Meeting the 2017 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for inflammatory myopathies (including dermatomyositis, DM; polymyositis, PM; antisynthetase syndrome, ASS; and necrotizing myopathy, NM); 4.2 Testing positive for myositis-specific antibodies; 4.3 For patients with muscle involvement, having a Manual Muscle Testing-8 (MMT-8) score below 142 and at least two abnormal findings among the following five core measures (Physician's Global Assessment, PhGA; Patient's Global Assessment, PtGA, or extra-muscular disease activity score ≥ 2 points; Health Assessment Questionnaire, HAQ, total score ≥ 0.25; muscle enzyme levels 1.5 times the upper limit of normal range); or having an MMT-8 score ≥ 142 but presenting with active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT); 4.4 Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.; 4.5 Definition of progressive condition: Demonstrating worsening myositis or rapidly progressive interstitial pneumonia.\n\n     Note: Meeting either criterion 4 or 5 is sufficient.\n  5. Relapsing and refractory Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis:\n\n     5.1 Meeting the 2022 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis.\n\n     5.2 Testing positive for ANCA-related antibodies (either MPO-ANCA or PR3-ANCA positive).\n\n     5.3 A Birmingham Vasculitis Activity Score (BVAS) of ≥15 points (out of a total of 63 points), indicating active vasculitis.\n\n     5.4 Definition of relapsing\u002Frefractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.\n  6. Relapsing and refractory Antiphospholipid Syndrome:\n\n6.1 Meeting the 2006 Sydney-revised diagnostic criteria for primary antiphospholipid syndrome; 6.2 Testing positive for antiphospholipid antibodies at moderate to high titers (IgG\u002FIgM antibodies against lupus anticoagulant, LA; beta-2 glycoprotein I, B2GP1; or anticardiolipin, acL, detected positive on more than two occasions within a 12-week period); 6.3 Definition of relapsing\u002Frefractory condition: Recurrence of thrombosis despite standard treatment with warfarin anticoagulation or alternative vitamin K antagonist (i.e., maintaining the required international normalized ratio, INR, for therapeutic management) or standard therapeutic doses of low molecular weight heparin (LMWH), in addition to previous treatment with corticosteroids and cyclophosphamide; 6.4 For catastrophic antiphospholipid syndrome, the following four criteria must be met: (1) involvement of three or more organs, systems, and\u002For tissues; (2) onset of symptoms within one week; (3) histological confirmation of small vessel occlusion in at least one organ or tissue; (4) presence of aPL (antiphospholipid antibodies).\n\nNote: Meeting either criterion 3 or 4 is sufficient.\n\nExclusion Criteria:\n\nSubjects who meet any of the following exclusion criteria will not be admitted to the study:\n\n1. Individuals with a severe history of drug allergies or those with an allergic constitution;\n2. Individuals with existing or suspected uncontrolled or treatable fungal, bacterial, viral, or other infections;\n3. Subjects with central nervous system diseases (excluding those with a history of epilepsy, psychiatric disorders, organic brain disease syndromes, cerebrovascular accidents, encephalitis, or central nervous system vasculitis resulting from the underlying disease);\n4. Subjects whose cardiac function cannot tolerate the study interventions;\n5. Subjects with congenital immunoglobulin deficiencies;\n6. Subjects with a history of malignant tumors within the past five years;\n7. Subjects with end-stage renal failure;\n8. Subjects who are positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titers exceeding the upper limit of detection; subjects who are positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; subjects who are positive for human immunodeficiency virus (HIV) antibody; and subjects who are positive for syphilis testing;\n9. History of symptomatic deep vein thrombosis or pulmonary embolism within the 6 months prior to screening;\n10. Subjects with psychiatric disorders or severe cognitive dysfunction;\n11. Subjects who have participated in other clinical trials within the past three months prior to enrollment;\n12. Subjects who have received immunosuppressive agents with therapeutic effects on the disease within five half-lives prior to enrollment or biological agents within four weeks prior to enrollment;\n13. Pregnant women or women planning to become pregnant;\n14. Subjects whom the investigator believes have other reasons that preclude their inclusion in this study.","65 Years",{"count":81,"type":22},18,[53],"This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed\u002Frefractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), including LN and SLE-ITP, Sjogren's Syndrome, etc. Aproximately 18 patients aged 18-65 will receive a single infusion of YTS109 cells. The dose groups are set to commence at 3E6 STAR -T cells\u002Fkg, employing a 3+3 escalation principle for dose titration. The primary objective of this study is to evaluate the safety of YTS109 cells therapy in treating recurrent\u002Frefractory autoimmune diseases, while the secondary objectives are to assess the efficacy of YTS109 cells as well as their pharmacokinetic and pharmacodynamic characteristics. The primary endpoint is observations of types, severity, and frequency of adverse events (AEs) and efficacy assessment. This single-arm, open-label trial will enroll patients across Institute of Hematology \\& Blood Diseases Hospital.",[85,86,87,88,89,28],"Systemic Lupus Erythematosus (SLE)","Lupus Nephritis (LN)","Sjogren's Syndrome (SS)","Inflammatory Myopathy","Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis",[91],"Relapsing\u002FRefractory Autoimmune Diseases","2026-02-27",{"date":94,"type":33},"2026-03-02",{"date":96,"type":33},"2025-08-13",{"date":98,"type":22},"2027-08-13",{"name":100,"class":70},"China Immunotech (Beijing) Biotechnology Co., Ltd.",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":108,"targetDuration":4,"studyType":23,"phases":109,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":114,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":41},"100600994","phase-1-a-clinical-study-of-yts109-cell-for-rr-autoimmune-diseases-100600994","NCT07104721","A Clinical Study of YTS109 Cell for R\u002FR Autoimmune Diseases","An Exploratory Clinical Study on the Safety and Efficacy of YTS109 Cell in Subjects With Relapsing\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\n* Subjects must meet both the following common inclusion criteria and disease-specific inclusion criteria simultaneously to be eligible for participation in this study:\n\nCommon inclusion criteria:\n\n1\\. Age ranges from 18 to 65 years old (including threshold), regardless of gender.\n\n2\\. Essential Organ Function Criteria:\n\n1. Bone marrow: Neutrophils ≥1×10\\^9\u002FL (within 2 weeks, excluding granulocyte colony-stimulating factor use); Hemoglobin ≥60 g\u002FL.\n2. Liver: ALT\u002FAST ≤3×ULN (disease-related elevations permitted). TBIL≤1.5×ULN (disease-related elevations permitted).\n3. Renal: CrCl≥30mL\u002Fmin (Cockcroft-Gault formula, excluding acute declines).\n4. Coagulation: INR\u002FPT ≤1.5×ULN.\n5. Cardiovascular: Hemodynamic stability. 3. Fertile females or males with partners of childbearing age must use medically approved contraception or abstain during and ≥12 months post- treatment. Negative serum HCG test (within 7 days pre-enrollment) for fertile females; non-lactating.\n\n4\\. Voluntary participation with signed informed consent and compliance.\n\nSpecific inclusion criteria:\n\nRelapsing and refractory systemic lupus erythematosus:\n\n1. Meeting the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for systemic lupus erythematosus (SLE);\n2. Meeting the criteria for refractory lupus nephritis (LN) or SLE-associated immune thrombocytopenia (SLE-ITP), defined as follows:\n\n\u003C!-- -->\n\n1. Refractory Lupus Nephritis:\n\n   * Failure to achieve remission following treatment regimens comprising glucocorticoids and at least two immunosuppressive agents (including cyclophosphamide \\[CTX\\], tacrolimus, mycophenolate mofetil \\[MMF\\], and cyclosporine) and\u002For biologic agents (including rituximab, belimumab, telitacicept, etc.).\n   * Urine protein-to-creatinine ratio (UPCR) ≥1.0 g\u002Fg or 24-hour urine protein excretion \\>1.0 g at screening.\n   * Renal pathology must be performed within 6 months prior to the screening visit or during the screening period, demonstrating proliferative lupus nephritis (Class III or IV, with or without Class V) according to the 2003 International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) criteria, with ≤50% glomerular sclerosis noted in the pathology report.\n2. Refractory SLE-Associated Immune Thrombocytopenia:\n\n   * Failure to achieve partial remission after at least one course of methylprednisolone pulse therapy (0.5-1 g × 3-5 days) or high-dose glucocorticoids (equivalent to 1 mg\u002Fkg\u002Fday of prednisone) combined with one or more immunosuppressive agents (including biologic agents) for at least 3 months, or inability to maintain therapeutic efficacy during glucocorticoid tapering. Platelet count \\\u003C50 × 10⁹\u002FL on at least two consecutive complete blood count tests prior to enrollment. Exclusion of thrombocytopenia due to non-SLE causes, such as infection, bone marrow suppression, or hypersplenism.\n\nRelapsing and refractory Sjögren's syndrome:\n\n1. Meeting the 2002 American-European Consensus Group (AECG) criteria or the 2016 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) classification criteria for primary Sjögren's syndrome;\n2. Having a disease activity score of EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) ≥ 6;\n3. Testing positive for anti-SSA\u002FRo antibodies;\n4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids in combination with any of the following immunosuppressive agents or biological agents: cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.\n\nRelapsing and refractory Sjogren's Syndrome:\n\n1\\. Meeting the 2013 American College of Rheumatology (ACR) classification criteria for systemic sclerosis; 2. Testing positive for systemic sclerosis-related antibodies; 3. Presenting with diffuse cutaneous sclerosis or active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT); 4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.; 5. Definition of progressive condition: Demonstrating rapid skin progression (an increase in modified Rodnan skin score, mRSS, of \\>25%) or pulmonary disease progression (a 10% decrease in forced vital capacity, FVC, or a \\>5% decrease in FVC accompanied by a 15% decrease in diffusion capacity for carbon monoxide, DLCO).\n\nNote: Meeting either criterion 4 or 5 is sufficient.\n\nRelapsing and refractory Inflammatory Myopathy:\n\n1\\. Meeting the 2017 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for inflammatory myopathies (including dermatomyositis, DM; polymyositis, PM; antisynthetase syndrome, ASS; and necrotizing myopathy, NM); 2. Testing positive for myositis-specific antibodies; 3. For patients with muscle involvement, having a Manual Muscle Testing-8 (MMT-8) score below 142 and at least two abnormal findings among the following five core measures (Physician's Global Assessment, PhGA; Patient's Global Assessment, PtGA, or extra-muscular disease activity score ≥ 2 points; Health Assessment Questionnaire, HAQ, total score ≥ 0.25; muscle enzyme levels 1.5 times the upper limit of normal range); or having an MMT-8 score ≥ 142 but presenting with active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT); 4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.; 5. Definition of progressive condition: Demonstrating worsening myositis or rapidly progressive interstitial pneumonia.\n\nNote: Meeting either criterion 4 or 5 is sufficient.\n\nRelapsing and refractory Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis:\n\n1\\. Meeting the 2022 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis.\n\n2\\. Testing positive for ANCA-related antibodies (either MPO-ANCA or PR3-ANCA positive).\n\n3\\. A Birmingham Vasculitis Activity Score (BVAS) of ≥15 points (out of a total of 63 points), indicating active vasculitis.\n\n4\\. Definition of relapsing\u002Frefractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.\n\nRelapsing and refractory Antiphospholipid Syndrome:\n\n1. Meeting the 2006 Sydney-revised diagnostic criteria for primary antiphospholipid syndrome;\n2. Testing positive for antiphospholipid antibodies at moderate to high titers (IgG\u002FIgM antibodies against lupus anticoagulant, LA; beta-2 glycoprotein I, B2GP1; or anticardiolipin, acL, detected positive on more than two occasions within a 12-week period);\n3. Definition of relapsing\u002Frefractory condition: Recurrence of thrombosis despite standard treatment with warfarin anticoagulation or alternative vitamin K antagonist (i.e., maintaining the required international normalized ratio, INR, for therapeutic management) or standard therapeutic doses of low molecular weight heparin (LMWH), in addition to previous treatment with corticosteroids and cyclophosphamide;\n4. For catastrophic antiphospholipid syndrome, the following four criteria must be met: (1) involvement of three or more organs, systems, and\u002For tissues; (2) onset of symptoms within one week; (3) histological confirmation of small vessel occlusion in at least one organ or tissue; (4) presence of aPL (antiphospholipid antibodies).\n\nNote: Meeting either criterion 3 or 4 is sufficient.\n\nExclusion Criteria:\n\n\\- Subjects who meet any of the following exclusion criteria will not be admitted to the study:\n\n1. Individuals with a severe history of drug allergies or those with an allergic constitution;\n2. Individuals with existing or suspected uncontrolled or treatable fungal, bacterial, viral, or other infections;\n3. Subjects with central nervous system diseases (excluding those with a history of epilepsy, psychiatric disorders, organic brain disease syndromes, cerebrovascular accidents, encephalitis, or central nervous system vasculitis resulting from the underlying disease);\n4. Subjects whose cardiac function cannot tolerate the study interventions;\n5. Subjects with congenital immunoglobulin deficiencies;\n6. Subjects with a history of malignant tumors within the past five years;\n7. Subjects with end-stage renal failure;\n8. Subjects who are positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titers exceeding the upper limit of detection; subjects who are positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; subjects who are positive for human immunodeficiency virus (HIV) antibody; and subjects who are positive for syphilis testing;\n9. History of symptomatic deep vein thrombosis or pulmonary embolism within the 6 months prior to screening;\n10. Subjects with psychiatric disorders or severe cognitive dysfunction;\n11. Subjects who have participated in other clinical trials within the past three months prior to enrollment;\n12. Subjects who have received immunosuppressive agents with therapeutic effects on the disease within five half-lives prior to enrollment or biological agents within four weeks prior to enrollment;\n13. Pregnant women or women planning to become pregnant;\n14. Subjects whom the investigator believes have other reasons that preclude their inclusion in this study.",{"count":81,"type":22},[53],"This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed\u002Frefractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), including LN and SLE-ITP, Sjogren's Syndrome, etc. Aproximately 18 patients aged 18-65 will receive a single infusion of YTS109 cells. The dose groups are set to commence at 3×10⁶ STAR -T cells\u002Fkg, employing a 3+3 escalation principle for dose titration. The primary objective of this study is to evaluate the safety of YTS109 cells therapy in treating recurrent\u002Frefractory autoimmune diseases, while the secondary objectives are to assess the efficacy of YTS109 cells as well as their pharmacokinetic and pharmacodynamic characteristics. The primary endpoint is observations of types, severity, and frequency of adverse events (AEs) and efficacy assessment. This single-arm, open-label trial will enroll patients across The First Affiliated Hospital of Anhui Medical University.",[85,86,112,88,89,28],"Systemic Sclerosis (SSc)",[91],{"date":94,"type":33},{"date":116,"type":33},"2025-08-04",{"date":118,"type":22},"2028-12-30",{"name":100,"class":70},{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":17,"minAge":127,"maxAge":18,"enrollmentInfo":128,"targetDuration":4,"studyType":23,"phases":129,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":41},"100626699","phase-1-yts109-in-pediatric-relapsedrefractory-autoimmune-diseases-100626699","NCT07439029","YTS109 in Pediatric Relapsed\u002FRefractory Autoimmune Diseases","An Exploratory Clinical Study of the Safety and Efficacy of YTS109 Cell Injection in Children With Relapsed\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\n\\-\n\n1. Age 5 to \\\u003C18 years at screening; sex not restricted.\n2. CD19 positivity: Presence of CD19-positive B cells in peripheral blood, confirmed by flow cytometry.\n3. Adequate major organ function, meeting all of the following criteria:\n\n1）Bone marrow function:\n\n1. Absolute neutrophil count (ANC) ≥ 1.0 × 10\\^9\u002FL (no colony-stimulating factor use within 2 weeks prior to testing; neutropenia attributable to the underlying disease may be allowed);\n2. Hemoglobin ≥ 60 g\u002FL. 2）Hepatic function: ALT ≤ 3 × ULN (exceptions allowed for elevations attributable to the underlying disease); AST ≤ 3 × ULN (exceptions allowed for elevations attributable to the underlying disease); Total bilirubin (TBIL) ≤ 1.5 × ULN (exceptions allowed for elevations attributable to the underlying disease).\n\n   3）Renal function: Estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73 m², calculated using the Schwartz formula (exceptions allowed for reduced renal function attributable to the underlying disease).\n\n   4）Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN and prothrombin time (PT) ≤ 1.5 × ULN.\n\n   5）Cardiac status: Hemodynamically stable. 4. Females of childbearing potential must be not pregnant and not breastfeeding during screening and throughout the study period.\n\n   5\\. The participant and the legal guardian are willing to participate, provide written informed consent, and can comply with study procedures and follow-up.\n\n   Specific inclusion criteria:\n\n   Recurrent refractory systemic lupus erythematosus\n\n   1\\. Meets the 2019 EULAR\u002FACR classification criteria for systemic lupus erythematosus (SLE).\n\n   2\\. Active disease, defined as either: SELENA-SLEDAI ≥ 6 and at least one BILAG-2004 organ domain score of A (severe activity) or two domains scored B (moderate activity), or a combination thereof; or SELENA-SLEDAI ≥ 8.\n\n   3\\. Relapsed\u002Frefractory or intolerant to conventional therapy, defined as one of the following: Inadequate response after \\>3 months of conventional therapy; or intolerance to treatment-related adverse effects; or Disease flare\u002Frecurrence after achieving remission based on the LLDAS criteria. Conventional therapy is defined as treatment with glucocorticoids and cyclophosphamide, and one or more of the following immunomodulatory agents: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or any biologic agent, including rituximab, belimumab, and telitacicept.\n\n   4\\. If renal involvement is present, a kidney biopsy must have been performed within 12 months prior to treatment, demonstrating active lesions or predominantly active lesions on pathology.\n\n   Relapsing refractory\u002Fprogressive diffuse systemic sclerosis\n   1. Meets the 2013 ACR classification criteria for systemic sclerosis and is consistent with the diffuse cutaneous subtype (dcSSc).\n   2. Positive for any antinuclear antibody (ANA) or systemic sclerosis-associated autoantibody.\n   3. Evidence of diffuse cutaneous skin sclerosis and\u002For active interstitial lung disease (ILD), defined as ground-glass opacities on high-resolution computed tomography (HRCT).\n   4. Inadequate response to conventional therapy for \\>3 months or disease relapse\u002Frecurrence after achieving remission. Conventional therapy is defined as treatment with glucocorticoids and cyclophosphamide, and one or more of the following immunomodulatory agents: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, JAK inhibitors, or any biologic agent, including rituximab, tocilizumab, TNF-α inhibitors (etanercept, adalimumab, infliximab), and telitacicept.\n   5. Progressive disease, defined as either:\n\n   1） Rapid skin progression: mRSS increase \\>25%; or 2） Progressive lung disease: FVC decline ≥10%, or FVC decline ≥5% accompanied by DLCO decline ≥15%.\n\n   Note: Criterion 4 or 5 must be met (either one is sufficient).\n\n   Recurrent refractory\u002Fprogressive inflammatory myopathy:\n\n   1\\. Meets the 2017 EULAR\u002FACR classification criteria for idiopathic inflammatory myopathies (including dermatomyositis \\[DM\\], polymyositis \\[PM\\], antisynthetase syndrome \\[ASS\\], and necrotizing myopathy \\[NM\\]).\n\n   2\\. Positive for myositis-specific and\u002For myositis-associated autoantibodies. 3. Evidence of active disease meeting either of the following:\n\n   1\\) Muscle involvement: CMAS \\\u003C 30 and at least two abnormal findings among the following core measures: Physician Global Assessment (PhGA) ≥ 2, Patient\u002FParent Global Assessment (PtGA) ≥ 2, extra-muscular disease activity score ≥ 2, and\u002For serum muscle enzymes ≥ 1.5 × ULN; or 2) Interstitial lung disease (ILD): CMAS ≥ 30 but with active ILD, defined as ground-glass opacities on high-resolution computed tomography (HRCT).\n\n   4\\. Inadequate response to conventional therapy for \\>3 months, or intolerance to treatment-related adverse effects, or relapse\u002Frecurrence after achieving remission. Conventional therapy is defined as treatment with glucocorticoids and cyclophosphamide, and one or more of the following immunomodulatory agents: antimalarials, intravenous immunoglobulin (IVIG), azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, JAK inhibitors, or any biologic agent, including rituximab, tocilizumab, TNF-α inhibitors (etanercept, adalimumab, infliximab), and telitacicept.\n\n   5\\. Progressive disease, defined as worsening myositis or rapidly progressive interstitial lung disease (RP-ILD).\n\n   Note: Criterion 4 or 5 must be met (either one is sufficient). Recurrent refractory sjogren's syndrome\n   1. Meets the 2002 American-European Consensus Group (AECG) classification criteria for primary Sjögren's syndrome or the 2018 Japanese classification criteria.\n   2. Active disease, defined as ESSDAI ≥ 6.\n   3. Positive for anti-SSA\u002FRo antibodies.\n   4. Inadequate response to conventional therapy for \\>3 months or relapse\u002Frecurrence after achieving remission. Conventional therapy is defined as treatment with glucocorticoids and cyclophosphamide, and one or more of the following immunomodulatory agents: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or any biologic agent, including rituximab, belimumab, and telitacicept.\n\n   Recurrent\u002Frefractory ANCA-associated vasculitis:\n   1. Meets the 2022 ACR\u002FEULAR classification criteria for ANCA-associated vasculitis, including microscopic polyangiitis (MPA), granulomatosis with polyangiitis (GPA), and eosinophilic granulomatosis with polyangiitis (EGPA).\n   2. Positive for ANCA, defined as MPO-ANCA and\u002For PR3-ANCA positivity.\n   3. Active vasculitis, defined as Paediatric Vasculitis Activity Score (PVAS) ≥ 15 (maximum score 65).\n   4. Inadequate response to conventional therapy for \\>3 months or relapse\u002Frecurrence after achieving remission. Conventional therapy is defined as treatment with glucocorticoids and cyclophosphamide, and one or more of the following immunomodulatory agents: azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or any biologic agent, including rituximab, belimumab, and telitacicept.\n\n      Recurrent refractory\u002Fcatastrophic antiphospholipid syndrome:\n\n   1\\. Meets the 2006 revised Sydney classification criteria for primary antiphospholipid syndrome (APS).\n\n   2\\. Positive for antiphospholipid antibodies (aPL) at medium to high titers, defined as lupus anticoagulant (LA), anti-β2-glycoprotein I (anti-β2GPI) IgG\u002FIgM, and\u002For anticardiolipin (aCL) IgG\u002FIgM, with ≥2 positive tests at least 12 weeks apart.\n\n   3\\. Relapsed\u002Frefractory APS, defined as recurrent thrombosis despite standard-of-care therapy, including:\n   1. Anticoagulation with warfarin or another vitamin K antagonist (VKA) with INR maintained within the target therapeutic range, or therapeutic-dose low-molecular-weight heparin (LMWH), and\n   2. Prior treatment with glucocorticoids and cyclophosphamide, with subsequent recurrent thrombosis.\n\n   4\\. Catastrophic antiphospholipid syndrome (CAPS), defined by fulfillment of all four criteria:1) Involvement of three or more organs, systems, and\u002For tissues; 2) Development of manifestations within one week; 3)Histopathologic confirmation of small-vessel thrombosis\u002Focclusion in at least one organ or tissue; 4) aPL positivity.\n\n   Note: Criterion 3 or 4 must be met (either one is sufficient).\n\n   Exclusion Criteria:\n   1. History of severe drug allergy or a known allergic predisposition.\n   2. Presence of, or suspected uncontrolled infection requiring treatment, including fungal, bacterial, viral, or other infections.\n   3. Central nervous system (CNS) disorders, except for prior seizures, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis, or CNS vasculitis attributable to the underlying disease, as determined by the investigator.\n   4. Cardiac dysfunction deemed unable to tolerate study treatment (i.e., inadequate cardiac function at the investigator's discretion).\n   5. Known congenital immunoglobulin deficiency.\n   6. Presence of severe congenital structural malformations or syndromic birth defects (e.g., severe cardiovascular malformations, severe CNS malformations), or a confirmed diagnosis of a severe inherited metabolic disorder that, in the investigator's judgment, may significantly increase trial-related risk or interfere with compliance and interpretation of results.\n   7. History of malignancy within the past 5 years.\n   8. End-stage renal disease.\n   9. Evidence of certain chronic\u002Factive infections, including: HBsAg-positive, or HBcAb-positive with peripheral blood HBV DNA above the upper limit of detection; Anti-HCV antibody positive with detectable HCV RNA; HIV antibody positive; Positive syphilis test.\n   10. Psychiatric illness or severe cognitive impairment.\n   11. Participation in another clinical trial within 3 months prior to enrollment.\n   12. Use of immunosuppressive agents with therapeutic effects on the underlying disease within five half-lives prior to enrollment, or use of biologic agents within 4 weeks prior to enrollment.\n   13. Pregnant or planning pregnancy (females).\n   14. Any other condition that, in the investigator's opinion, makes the participant unsuitable for enrollment in this study.","5 Years",{"count":5,"type":22},[53],"This exploratory, single-arm, open-label study will evaluate the safety and preliminary efficacy of YTS109 cell therapy in pediatric patients with relapsed\u002Frefractory autoimmune diseases, including systemic lupus erythematosus, diffuse systemic sclerosis, idiopathic inflammatory myopathies, and Sjögren's syndrome, as well as other eligible autoimmune diseases defined by the protocol eligibility criteria. Approximately 12 patients aged 5 to \\\u003C18 years will be enrolled at Children's Hospital of Fudan University and will receive a single intravenous infusion of YTS109 cells. Dose escalation will follow a standard 3+3 design starting at 1.5 × 10\\^6 cells\u002Fkg. The primary objective is to assess the safety and preliminary efficacy of YTS109 cell therapy in this population. Secondary objectives include characterizing the pharmacokinetic and pharmacodynamic profiles of YTS109 cells. Primary endpoints include the type, severity, and frequency of adverse events, along with efficacy assessments.",[85,132,133,134,28,135],"Diffuse Systemic Sclerosis","Idiopathic Inflammatory Myopathies (IIMs)","ANCA Associated Vasculitis (AAV)","Sjogren's Syndrome (SS)","NOT_YET_RECRUITING","2026-02-23",{"date":92,"type":33},{"date":140,"type":22},"2026-03",{"date":142,"type":22},"2030-07",{"name":144,"class":40},"Children's Hospital of Fudan University",{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":153,"targetDuration":155,"studyType":156,"phases":4,"briefSummary":157,"conditions":158,"keywords":161,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":179},"100621557","observational-study-to-evaluate-the-effectiveness-of-doacs-for-secondary-thrombosis-prevention-in-low-risk-thrombotic-aps-patients-100621557","NCT07372170","Observational Study to Evaluate the Effectiveness of DOACS for Secondary Thrombosis Prevention in Low-risk Thrombotic APS Patients","Real-world Observational Study to Evaluate the Effectiveness and Safety of Direct Oral Anticoagulants Compared With Vitamin K Antagonists for Secondary Thrombosis Prevention in Low-risk Thrombotic Antiphospholipid Syndrome Patients","DOACS-APS","Inclusion Criteria:\n\n* Adults (≥18 years) with a diagnosis of thrombotic antiphospholipid syndrome.\n* Low-risk antiphospholipid syndrome defined by previous venous thrombosis and a single or double positive antiphospholipid antibody profile (lupus anticoagulant, anticardiolipin antibodies, and\u002For anti-beta-2-glycoprotein I antibodies).\n* Patients receiving long-term anticoagulant treatment with direct oral anticoagulants or vitamin K antagonists according to routine clinical practice.\n* At least 2 weeks of continuous anticoagulant treatment before study inclusion.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years.\n* Triple antiphospholipid antibody positivity.\n* History of arterial thrombosis.\n* Anticoagulation for indications other than secondary prevention of venous thrombosis related to antiphospholipid syndrome.",{"count":154,"type":22},600,"36 Months","OBSERVATIONAL","This is an observational study designed to evaluate the effectiveness and safety of direct oral anticoagulants (DOACs) compared with vitamin K antagonists (VKAs) for the secondary prevention of thrombosis in patients with low-risk thrombotic antiphospholipid syndrome.\n\nAntiphospholipid syndrome is an autoimmune disorder associated with an increased risk of thrombotic events. Although VKAs have traditionally been the standard treatment, DOACs are increasingly used in clinical practice in selected patients, despite limited evidence in this setting.\n\nThis study includes patients with previous venous thrombosis and a low-risk serological profile who are treated with either DOACs or VKAs according to routine clinical practice. The primary objective is to compare thrombotic recurrence and bleeding events between both treatment strategies.\n\nThe results of this study will contribute to improving knowledge about the use of DOACs in patients with low-risk thrombotic antiphospholipid syndrome.",[28,159,160],"Venous Thrombosis (Disorder)","Thrombophilia",[162,163,164,165,166,167,168,169],"Direct oral anticoagulants","Vitamin K antagonists","Low-risk antiphospholipid syndrome","Secondary thrombosis prevention","Real-world study","Observational study","Venous Thrombosis","Antiphospholipid Antibody Profile","2026-01-28",{"date":172,"type":33},"2026-01-30",{"date":174,"type":33},"2025-12-01",{"date":176,"type":22},"2028-12-31",{"name":178,"class":40},"Infanta Leonor University Hospital",2,{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":187,"enrollmentInfo":188,"targetDuration":127,"studyType":156,"phases":4,"briefSummary":190,"conditions":191,"keywords":192,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":41},"100606697","follow-up-cohort-of-patients-with-antiphospholipid-syndrome-100606697","NCT07178925","Follow-up Cohort of Patients With Antiphospholipid Syndrome","ReLaps","Inclusion Criteria:\n\n* Adult patients over 18 years of age and under 75 years of age\n* Antiphospholipid syndrome meeting the 2006 Sydney classification\n\nExclusion Criteria:\n\n* Patients under the age of 75 or over\n* Syndrome not meeting the 2006 Sydney classification","75 Years",{"count":189,"type":22},200,"Antiphospholipid syndrome (APLS) is a rare pathology characterized by the association of thrombotic (arterial, venous) or obstetric clinical manifestations and the persistent presence at least twelve weeks apart of antiphospholipid antibodies (APL). It is also accompanied by accelerated atherosclerosis responsible for an increased incidence of myocardial infarction, peripheral arterial disease and stroke explaining the high cardiovascular morbidity and mortality of these patients. APS can be isolated (primary) or integrated into an autoimmune pathology such as systemic lupus erythematosus (SLE), thus defining secondary APS. Current treatment is based on anticoagulation. Currently, epidemiological data that have evaluated recurrences have estimated a rate of 5% per year. However, these studies are old and due to the significant heterogeneity of patients included in this registry, it seems that these figures are not in agreement with clinical reality.\n\nFurthermore, several new therapeutic developments have emerged in the field of anticoagulation with the marketing of DOACs, making the EUROPHOSPHOLIPIDE data questionable. Currently, there are no clinical studies to justify the use of DOACs in this indication, but several patients have received these drugs due to intolerance or refusal of vitamin K antagonists. The other therapeutic innovation compared to the data from the EUROPHOSPHOLIPIDE cohort is the increasing use of hydroxychloroquine in clinical practice in patients with primary APS. A trial (APLAQUINE) is currently underway in our department which aims to study the endothelial protective effect of this treatment in patients with primary APS.",[28],[193,194,195],"thrombotic recurrence rate","risk factors","treatment tolerance","2025-09-10",{"date":198,"type":33},"2025-09-17",{"date":200,"type":33},"2019-10-16",{"date":202,"type":22},"2031-10-16",{"name":204,"class":40},"University Hospital, Rouen",{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":187,"enrollmentInfo":213,"targetDuration":4,"studyType":156,"phases":4,"briefSummary":215,"conditions":216,"keywords":223,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":4},"100601248","hematological-disorders-in-ehpvo-patients-100601248","NCT07108023","Hematological Disorders in EHPVO Patients","A Prospective Study of the Spectrum of Haematological Disorders in Patients With Extrahepatic Portal Vein Obstruction","EHPVO-HEM","Inclusion Criteria:\n\n* Age 18 years or older . Diagnosis of extra hepatic portal vein obstruction based on imaging ( Doppler, CT , MRI ) preserved liver function . Available complete medical records including CBC , LFTs and coagulation profile .\n\nExclusion Criteria:\n\n* Patients with cirrhosis or intrahepatic portal hypertension • Incomplete or missing medical records • Patients with known hematologic malignancies or undergoing chemotherapy",{"count":214,"type":22},115,"This study focuses on patients who have a condition called extrahepatic portal vein obstruction (EHPVO), where a blood clot blocks the portal vein outside the liver. This blockage can cause problems like an enlarged spleen, bleeding from swollen veins in the digestive system, and low blood cell counts. Many of these patients may have hidden blood disorders that increase the risk of clotting, such as myeloproliferative neoplasms (MPNs), antiphospholipid syndrome (APS), or paroxysmal nocturnal hemoglobinuria (PNH). This study will collect and analyze blood test results-such as complete blood count (CBC), liver function tests (LFTs), and clotting tests-from patients with EHPVO. The aim is to find patterns that may suggest an underlying blood disorder, even if the patient doesn't show obvious symptoms.By understanding these patterns early, doctors may be able to diagnose and treat the root causes of clotting in these patients more accurately, helping prevent complications and improve outcomes.",[217,160,218,28,219,220,221,222],"Extrahepatic Portal Vein Obstruction (EHPVO)","Myeloproliferative Neoplasms (MPN)","Paroxysmal Nocturnal Hemoglobinuria (PNH)","Thrombocytopenia","Anemia","Leukopenia",[224,225,226,227,228,229,230,231,232,233],"Portal vein thrombosis","EHPVO","Hypersplenism","Hematological disorders","Coagulation profile","Liver function tests","CBC","JAK2 mutation","Thrombosis in MPN","Cross-sectional study","2025-07-31",{"date":236,"type":33},"2025-08-06",{"date":238,"type":22},"2025-08",{"date":240,"type":22},"2025-12",{"name":242,"class":40},"Rahab Nady",{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":77,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":249,"targetDuration":4,"studyType":23,"phases":250,"briefSummary":251,"conditions":252,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":41},"100591301","phase-1-a-clinical-study-of-yts109-cell-in-rr-autoimmune-diseases-100591301","NCT06978647","A Clinical Study of YTS109 Cell in R\u002FR Autoimmune Diseases","Inclusion Criteria:\n\n* Subjects must meet both the following common inclusion criteria and disease-specific inclusion criteria simultaneously to be eligible for participation in this study:\n\nCommon inclusion criteria:\n\n1. Age ranges from 18 to 65 years old (including threshold), regardless of gender.\n2. Detection of positive CD19 expression on peripheral blood B cells by flow cytometry.\n3. Essential Organ Function Criteria:\n\n\u003C!-- -->\n\n1. Bone marrow: Neutrophils ≥1×10\\^9\u002FL (within 2 weeks, excluding granulocyte colony-stimulating factor use).\n\n   Hemoglobin ≥60 g\u002FL.\n2. Liver: ALT\u002FAST ≤3×ULN (disease-related elevations permitted). TBIL ≤1.5×ULN (disease-related elevations permitted).\n3. Renal: CrCl≥30mL\u002Fmin (Cockcroft-Gault formula, excluding acute declines).\n4. Coagulation: INR\u002FPT ≤1.5×ULN.\n5. Cardiovascular: Hemodynamic stability. 4. Fertile females or males with partners of childbearing age must use medically approved contraception or abstain during and ≥12 months post- treatment. Negative serum HCG test (within 7 days pre-enrollment) for fertile females; non-lactating.\n\n5\\. Voluntary participation with signed informed consent and compliance.\n\nSpecific inclusion criteria:\n\nRelapsing and refractory systemic lupus erythematosus:\n\n1\\. Meeting the EULAR\u002FACR 2019 SLE Classification Criteria; 2. SELENA SLEDAI≥6, or the presence of significant organ involvement, such as lupus nephritis (LN), etc; 3. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing treatment with a regimen containing at least two immunosuppressive agents (including glucocorticoids, cyclophosphamide, tacrolimus, mycophenolate mofetil (MMF), and cyclosporine) and\u002For biological agents for a minimum duration of two months.\n\nRelapsing and refractory Sjögren's syndrome:\n\n1. Meeting the 2002 American-European Consensus Group (AECG) criteria or the 2016 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) classification criteria for primary Sjögren's syndrome;\n2. Having a disease activity score of EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) ≥ 6;\n3. Testing positive for anti-SSA\u002FRo antibodies;\n4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids in combination with any of the following immunosuppressive agents or biological agents: cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.\n\nRelapsing and refractory Sjogren's Syndrome:\n\n1. Meeting the 2013 American College of Rheumatology (ACR) classification criteria for systemic sclerosis;\n2. Testing positive for systemic sclerosis-related antibodies;\n3. Presenting with diffuse cutaneous sclerosis or active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT);\n4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.;\n5. Definition of progressive condition: Demonstrating rapid skin progression (an increase in modified Rodnan skin score, mRSS, of \\>25%) or pulmonary disease progression (a 10% decrease in forced vital capacity, FVC, or a \\>5% decrease in FVC accompanied by a 15% decrease in diffusion capacity for carbon monoxide, DLCO).\n\nNote: Meeting either criterion 4 or 5 is sufficient.\n\nRelapsing and refractory Inflammatory Myopathy:\n\n1. Meeting the 2017 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for inflammatory myopathies (including dermatomyositis, DM; polymyositis, PM; antisynthetase syndrome, ASS; and necrotizing myopathy, NM);\n2. Testing positive for myositis-specific antibodies;\n3. For patients with muscle involvement, having a Manual Muscle Testing-8 (MMT-8) score below 142 and at least two abnormal findings among the following five core measures (Physician's Global Assessment, PhGA; Patient's Global Assessment, PtGA, or extra-muscular disease activity score ≥ 2 points; Health Assessment Questionnaire, HAQ, total score ≥ 0.25; muscle enzyme levels 1.5 times the upper limit of normal range); or having an MMT-8 score ≥ 142 but presenting with active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT);\n4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.;\n5. Definition of progressive condition: Demonstrating worsening myositis or rapidly progressive interstitial pneumonia.\n\nNote: Meeting either criterion 4 or 5 is sufficient.\n\nRelapsing and refractory Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis:\n\n1. Meeting the 2022 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis.\n2. Testing positive for ANCA-related antibodies (either MPO-ANCA or PR3-ANCA positive).\n3. A Birmingham Vasculitis Activity Score (BVAS) of ≥15 points (out of a total of 63 points), indicating active vasculitis.\n4. Definition of relapsing\u002Frefractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.\n\nRelapsing and refractory Antiphospholipid Syndrome:\n\n1\\. Meeting the 2006 Sydney-revised diagnostic criteria for primary antiphospholipid syndrome; 2. Testing positive for antiphospholipid antibodies at moderate to high titers (IgG\u002FIgM antibodies against lupus anticoagulant, LA; beta-2 glycoprotein I, B2GP1; or anticardiolipin, acL, detected positive on more than two occasions within a 12-week period); 3. Definition of relapsing\u002Frefractory condition: Recurrence of thrombosis despite standard treatment with warfarin anticoagulation or alternative vitamin K antagonist (i.e., maintaining the required international normalized ratio, INR, for therapeutic management) or standard therapeutic doses of low molecular weight heparin (LMWH), in addition to previous treatment with corticosteroids and cyclophosphamide; 4. For catastrophic antiphospholipid syndrome, the following four criteria must be met: (1) involvement of three or more organs, systems, and\u002For tissues; (2) onset of symptoms within one week; (3) histological confirmation of small vessel occlusion in at least one organ or tissue; (4) presence of aPL (antiphospholipid antibodies).\n\nNote: Meeting either criterion 3 or 4 is sufficient.\n\nRelapsing and refractory Rheumatoid arthritis:\n\n1\\. Diagnosed with rheumatoid arthritis (RA) according to the 2010 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria, with a history of RA ≥ 3 months; 2. Inadequate response to at least two conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and at least one biological agent targeting cytokines\u002Fsignal transduction pathways (such as TNFα inhibitors, IL-6R antagonists, anti-CD20 monoclonal antibodies, etc.). (Note: Inadequate response to methotrexate or leflunomide, with stable treatment for ≥ 3 months prior to screening); 3. Moderate to severe active RA: swollen joint count (SJC) ≥ 6, tender joint count (TJC) ≥ 6; 4. Elevation of at least one inflammatory marker: erythrocyte sedimentation rate (ESR) ≥ 28 mm\u002Fh or C-reactive protein (CRP) ≥ upper limit of normal (ULN).\n\nRelapsing and refractory IgG4-Related Disease:\n\n1. Meeting the 2019 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) diagnostic criteria for IgG4-related disease (IgG4-RD);\n2. Having an IgG4-RD responder index (RI) ≥ 2 during the screening period, indicating active disease;\n3. Meeting the criteria for refractory or relapsing IgG4-RD:\n\n1\\) Refractory: Defined as a lack of response to steroid therapy or steroid plus immunosuppressive therapy (no clinical or radiological improvement, with a decrease in RI \\\u003C 2); 2) Relapse: Defined as new progression or recurrence of clinical symptoms or radiological manifestations in patients who have previously achieved remission, with or without an elevation in serum IgG4 levels (an increase in RI ≥ 2).\n\nExclusion Criteria:\n\n* Subjects who meet any of the following exclusion criteria will not be admitted to the study:\n\n  1. Individuals with a severe history of drug allergies or those with an allergic constitution;\n  2. Individuals with existing or suspected uncontrolled or treatable fungal, bacterial, viral, or other infections;\n  3. Subjects with central nervous system diseases (excluding those with a history of epilepsy, psychiatric disorders, organic brain disease syndromes, cerebrovascular accidents, encephalitis, or central nervous system vasculitis resulting from the underlying disease);\n  4. Subjects whose cardiac function cannot tolerate the study interventions;\n  5. Subjects with congenital immunoglobulin deficiencies;\n  6. Subjects with a history of malignant tumors within the past five years;\n  7. Subjects with end-stage renal failure;\n  8. Subjects who are positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titers exceeding the upper limit of detection; subjects who are positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; subjects who are positive for human immunodeficiency virus (HIV) antibody; and subjects who are positive for syphilis testing;\n  9. Subjects with psychiatric disorders or severe cognitive dysfunction;\n  10. Subjects who have participated in other clinical trials within the past three months prior to enrollment;\n  11. Subjects who have received immunosuppressive agents with therapeutic effects on the disease within five half-lives prior to enrollment or biological agents within four weeks prior to enrollment;\n  12. Pregnant women or women planning to become pregnant;\n  13. Subjects whom the investigator believes have other reasons that preclude their inclusion in this study.",{"count":5,"type":22},[53],"This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed\u002Frefractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), etc. Aproximately 6-12 patients aged 18-65 will receive a single infusion of YTS109 cells (1.5×10⁶ cells\u002Fkg). The main purpose of exploratory clinical research is to explore the efficacy and safety of YTS109 cell and the lymphodepletion regimen. The primary endpoint is observations of types, severity, and frequency of adverse events (AEs) and efficacy assessment. This single-arm, open-label trial will enroll patients across Chinese People's Liberation Army (PLA) General Hospital.",[85,112,88,89,28,253,254,255],"Rheumatoid Arthritis (RA)","IgG4-Related Diseases","Sjogren's Syndrome","2025-07-10",{"date":258,"type":33},"2025-07-14",{"date":260,"type":33},"2025-05-19",{"date":262,"type":22},"2027-05-19",{"name":100,"class":70},{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":270,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":156,"phases":4,"briefSummary":274,"conditions":275,"keywords":278,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":293},"100584057","doac-versus-vka-in-patients-with-non-high-risk-aps--prospective-cohort-study-100584057","NCT06884384","DOAC Versus VKA in Patients With Non-high-risk APS : Prospective Cohort Study","Direct Oral Anticoagulants Versus Warfarin in Patients With Non-high-risk Antiphospholipid Syndrome : Prospective Cohort Study","DOWAPS","Inclusion Criteria:\n\n* Persons who have received full information about the organization of the research and have given their oral consent to participate.\n* Male or female 18 years of age or older;\n* Carrier of venous thrombotic SAPL:\n\n  * Not favoured by a major or ≥ 2 minor favouring factors, if the patient doesn't present with obstetrical SAPL in accordance with the ACR\u002FEULAR 2023 clinical classification criteria.\n  * Or favored by ≥ 2 minors, if the patient has obstetrical SAPL: severe preeclampsia \\\u003C 34 weeks or placental insufficiency\n  * Regardless of how long the disease has been present\n  * With persistent positivity of at least one biological criterion:\n\n    * Positivity of circulating lupus anticoagulant or IgG anticardiolipid or IgG anti-beta-2GPI\n    * And persistence of the same positive test ≥ 12 weeks apart\n    * And With maximum delay of positivity of the 1st antiphospholipid test of 3 years after the thrombotic event\n* Current anticoagulant treatment, regardless of date of introduction\n\n  * rivaroxaban or apixaban\n  * or antivitamin K\n* Patient affiliated to a social security system\n\nExclusion Criteria:\n\n* Venous thrombotic event motivating current anticoagulant treatment favoured by a major favouring factor:\n\n  * Active cancer\n  * Hospitalization with bed rest for at least 3 days in the 3 months preceding the event\n  * Major trauma with fractures or spinal cord injury in the month preceding the event\n  * Surgery with general\u002Fspinal\u002Fepidural anesthesia for \\> 30 minutes in the 3 months preceding the event.\n* In the absence of a history of pre-eclampsia or placental insufficiency: venous thrombotic event motivating current anticoagulant treatment favoured by 2 or more minor favouring factors:\n\n  * Systemic autoimmune disease or active inflammatory bowel disease\n  * Acute\u002Fsevere infection\n  * Central venous catheter in the same vascular bed\n  * Hormone replacement therapy, estrogenic oral contraceptives, or hormone-stimulating therapy in progress\n  * Long-distance travel (≥ 8 hours)\n  * Obesity (BMI ≥ 30 kg\u002Fm²)\n  * Pregnancy or post-partum (6 weeks after delivery)\n  * Prolonged immobilization\n  * Surgery with general\u002Fspinal\u002Fepidural anesthesia for \\\u003C 30 minutes in the 3 months preceding the event\n* Known triple antiphospholipid positivity\n* Isolated IgM antiphospholipid positivity\n* History of known arterial thrombosis\n* History of known microcirculatory thrombosis\n* Known SAPL-related cardiac valvular disease\n* Persons referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code\n* Persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care under articles L. 3212-1 and L. 3213-1.\n* Glomerular filtration rate \\\u003C 30ml\u002Fmin.\n* Weight \\\u003C 50kg\n* History of thrombotic recurrence under well-administered anticoagulant therapy.",{"count":273,"type":22},310,"Antiphospholipid syndrome (APS) is a thrombotic disease requiring prolonged anticoagulation. Direct oral anticoagulants (DOACs) are indicated as 1st-line therapy in venous thrombosis, compared with VKAs, due to their easier handling and lower bleeding risk for equivalent efficacy. In APS, VKAs are still the reference treatment. However, DOACs are generally introduced in the acute phase of venous, before the diagnosis of APS. VKA have the disadvantage of numerous food and drug interactions, and therefore require close monitoring of INR, at least once a month. Because they are easier to use than VKAs, and the risk of bleeding is lower, patients are often reluctant to switch from DOACs to VKA. Studies have shown that APS patients with high thrombotic risk (positivity of all three antiphospholipid tests, history of arterial or small vessels thrombosis or cardiac valve damage) have an increased thrombotic risk during DOACs vs. VKA treatment. Since 2020, the ISTH guidelines have suggested avoiding DOACs in high-risk APS, but suggest continuing theim in other patients if they were introduced for venous thrombosis and if follow-up on DOACs is reassuring. In the case of high-risk APS patients, the relay is therefore systematic. For non-high-risk patients (the majority), there are no data to justify systematic switch. Given the quality-of-life advantages of DOACs over VKAs, patients are not always in favor of changing their anticoagulant therapy, especially if they have been on it for many years with good tolerability. For these reasons, a number of patients with non-high-risk APS remain on DOACs. Nevertheless, the limited data available on the efficacy of DOACs in non-high-risk patients are of low level of evidence and contradictory. In 2020, a literature review of non-high-risk SAPL patients treated with DOACs reported that 8.6% of them experienced thrombotic recurrence within 12 months, with no possible comparison with VKAs. A recent retrospective study with 96 patients reported that 15.4% of patients treated with DOACs had a recurrence, compared to 5.3% on VKAs. However, this difference was not statistically significant (p=0.15) due to a clear lack of power. The objective is to determine the frequency of thrombotic recurrences and to compare it according to the type of oral treatment, anti-Xa versus VKA, in non-high-risk APS, through a cohort study with prospective follow-up. The patient's usual antithrombotic treatment, DOAC and VKA, will be continued unchanged.",[28,276,277],"Cohort Study","Thrombotic and Bleeding Events",[279,280,281,282,283],"Antiphospholipid Syndrome","VKA treatment","DOAC Treatment","biological analysis","Thrombotic and bleeding events","2025-06-11",{"date":286,"type":33},"2025-06-13",{"date":288,"type":22},"2025-09-15",{"date":290,"type":22},"2031-09-15",{"name":292,"class":40},"Central Hospital, Nancy, France",13,{"id":295,"slug":296,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":300,"eligibilityCriteria":301,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":302,"targetDuration":127,"studyType":156,"phases":4,"briefSummary":304,"conditions":305,"keywords":308,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":41},"100587499","observatoire-international-des-patients-antiphospholipides-traits-par-anticoagulants-oraux-directs-100587499","NCT06929182","OBServaToIre interNational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs","OBServaToIre National Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs","OBSTINATE 2","Inclusion Criteria:\n\n* Person having received complete information on the organization of the research and not having opposed the use of this data\n* Male or female aged 18 and over;\n* Carrier of a thrombotic APS according to the Sydney classification criteria, regardless of the length of time in the disease\n* Having received a direct oral anticoagulant (DOAC) treatment which is currently discontinued.\n* Or currently treated with DOAC\n\nExclusion Criteria:\n\n* Incomplete Sydney classification criteria\n* Presence of a triple antiphospholipid positivity\n* History of arterial thrombosis\n* Persons referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the French Public Health Code:\n\n  * Pregnant, parturient or nursing mother\n  * Minor person (not emancipated)\n  * Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)\n  * Person of full age unable to express consent\n* Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric treatment under Articles L. 3212-1 and L. 3213-1 of the French Public Health Code.\n* Signature of the research participation opposition form",{"count":303,"type":22},500,"This registry will make it possible to collect large-scale data on SAPL patients, particularly those treated with DOACs, in order to better assess the frequency of thrombotic and hemorrhagic events in this population of \"non-high-risk\" thrombotic SAPL patients treated with DOACs. The results will help refine treatment recommendations and could form the basis of future clinical trials.\n\nIn this study, there will be no modification of the usual care and no additional follow-up. Follow-up will be carried out during the patient's usual visits in the context of his or her pathology, the frequency of which will be left to the discretion of the usual physician. No additional consultations\u002Fhospitalizations\u002Fexaminations will be carried out as part of the study. Data normally recorded in the medical record will be collected over a 5-year period, in line with standard patient follow-up.",[28,306,277,307],"Direct Oral Anticoagulants (DOACs)","Safety",[309,310,311,312,313],"safety of DOACs",""non-high risk" APS patients","Observatory","Phase IV","International","2025-04-16",{"date":316,"type":33},"2025-04-20",{"date":318,"type":22},"2025-07-01",{"date":320,"type":22},"2035-07-01",{"name":292,"class":40},{"id":323,"slug":324,"hasResults":11,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":4,"eligibilityCriteria":328,"healthyVolunteers":329,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":330,"targetDuration":4,"studyType":23,"phases":331,"briefSummary":332,"conditions":333,"keywords":334,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":41},"100573517","phase-2-effect-of-belimumab-on-antibody-titers-in-primary-aps-patients-100573517","NCT06747312","Effect of Belimumab on Antibody Titers in Primary APS Patients","A Single Center, Randomized Controlled, Open Label Trial to Explore the Regulatory Effect of Belimumab on Antibody Titers in Primary Antiphospholipid Syndrome Patients Carrying Medium to High Titers of Antiphospholipid Antibodies","Inclusion Criteria:\n\n* Age ≥ 18 years old.\n* Positive for high-titer antiphospholipid antibodies according to the criteria of the \"EULAR Guidelines for the Treatment of Antiphospholipid Syndrome in Adults\" published in 2019.\n* Stable APS regimen according to EULAR recommendations for antiphospholipid syndrome.\n* Female patients who are not pregnant, breastfeeding, of childbearing potential, or not using contraception.\n\nExclusion Criteria:\n\n* Patients with a history of malignant tumor in the past 5 years, except for basal cell carcinoma or squamous cell carcinoma of skin or cervical carcinoma in situ treated locally, and there is no evidence of metastasis within 3 years;\n* Patients with a history of primary immunodeficiency;\n* Serious lack of IgG (IgG level \\< 400 mg\u002FdL);\n* IgA deficiency (IgA level \\< 10 mg\u002FdL);\n* Patients with a current history of infection;\n* Patients with a current history of drug or alcohol abuse or dependence, or have a history of drug or alcohol abuse or dependence within 365 days before day 0;\n* HIV test is historically positive or HIV screening is positive;\n* Hepatitis status;\n* Patients with a history of allergic reaction caused by injection of contrast agent, human or mouse protein or monoclonal antibody;\n* Patients with other abnormal laboratory values with clinical significance;\n* If women with reproductive potential (WCBP) are included, please refer to the following special instructions;\n* Patients with concurrent major medical or mental illnesss;\n* Patients with diseases of liver, kidney, heart and other important organs,blood and Endocrine system;\n* Patients who have been vaccinated with live vaccine in the last month;\n* Patients who have participated in any clinical trial within 28 days before the initial screening and\u002For within 5 times of the half-life of the study compound (whichever is longer);\n* Patients who use B-cell targeted therapy drugs within one year, such as rituximab or epratuzumab;\n* Patients who use tumor necrosis factor inhibitor and interleukin receptor blocker within one year;\n* Patients who use Intravenous gamma globulin (IVIG) and prednisone ≥100mg\u002Fd for more than 14 days within one year or plasma exchange;\n* Patients with active infection (such as herpes zoster, HIV infection, active tuberculosis, etc.) during the screening period;\n* Patients with depression or suicidal thoughts;\n* Other conditions that the investigator considers would make the candidate unsuitable for the study.",true,{"count":21,"type":22},[25],"The purpose of this study is to evaluate the regulatory effect of Belimumab on the antiphospholipid antibody (aPL) as well as to observe related past and new clinical events in primary antiphospholipid syndrome patients.",[28],[335,28,336],"Belimumab","Antiphospholipid Antibodies","2024-12-20",{"date":339,"type":33},"2024-12-24",{"date":341,"type":33},"2024-04-01",{"date":343,"type":22},"2027-05-31",{"name":345,"class":40},"Ruijin Hospital"]