[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sjgrens-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sjgrens-syndrome":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,43,70,96,124,154,182,203],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100602033","phase-2-a-phase-ii-prospective-randomized-double-masked-controlled-study-assessing-the-safety--efficacy-of-rhprg4-450-gml-recombinant-human-proteoglycan-4-compared-to-vehicle-for-the-treatment-of-sjgrens-related-dry-eye-disease-100602033",false,"NCT07118241","A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CONTROLLED STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG\u002FML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE","Inclusion Criteria:\n\n1. Have the ability to comprehend and provide a signed and dated consent form.\n2. Are 18-75 years at time of consent;\n3. Have been diagnosed with SS for at least 3 months prior to ICF;\n4. Have been using artificial tears as the only topical treatment of SS related dry eye for at least 30 days prior to Visit 1;\n5. Have been stably using systemic medications for at least one month prior to Visit 1;\n6. Have Global SANDE score ≥ 40;\n7. Average VAS score for typical symptoms of dry eye (dryness, foreign body sensation, burning\u002Fstinging, itching, pain, stick feeling, blurred vision and photophobia) ≥ 25 mm, none \\\u003C 5 mm;\n8. Have Oxford corneal fluorescein staining grade of ≥ 1 and ≤ 2 in each eye (OD \\& OS both ≥ 1 and ≤ 2);\n9. Stated willingness to comply with all study procedures, attend all scheduled clinic visits, and continue participation for the duration of the study.\n10. Ability to self-administer study medication and willingness to adhere to the medication regimen.\n\nExclusion Criteria\n\n1. Are currently or have a history of any ocular or systemic disorder or condition other than dry eye that based on investigator judgment will interfere with the interpretation of the study results. Examples of ocular or systemic disorders or conditions include active ocular infection, conjunctivochalasis, superior limbic keratoconjunctivitis, limbal stem cell deficiency, allergic conjunctivitis, giant papillary conjunctivitis, atopic keratoconjunctivitis, anterior basement membrane dystrophies, neurotrophic keratitis, corneal dystrophy, exposure keratitis, moderate to severe blepharitis, ocular trauma, progressive or degenerative corneal conditions, uveitis, and systemic infection;\n2. Have used any topical ocular medications (other than artificial tears), therapeutic medical devices, or undergone ocular surgery within the 30 days prior to Visit 1. Topical ocular medications include cyclosporine, lifitegrast, corticosteroid eye drops, and autologous\u002Fserum. Therapeutic medical devices include trigeminal stimulation, meibomian glad warming (excepting at home masks) or expression, intense pulsed light, low level light therapy, etc. Ocular surgeries include laser or refractive surgical procedures, insertion of punctal or punctal cauterization;\n3. Are unwilling to forgo the use of topical medications (other than IMP and limited artificial tear use), medical devices or ocular surgery from Visit 1 through Visit 4.\n4. Have only one eye;\n5. Are unwilling to adhere to t.i.d. administration of vehicle during run-in;\n6. Are unwilling to limit the use of artificial tears to no more than 4 days during run-in;\n7. Have begun regularly using systemic compounds for SS or SS-related dry eye during the one month prior to Visit 1. Systemic compounds include omega-3 oil (fish oil, flaxseed oil, etc.), systemic corticosteroids, immunosuppressants, and biologics that based on investigator judgment will interfere with the interpretation of the study results.\n8. Are unwilling to maintain a stable regimen of systemic compound use during the duration of the study;\n9. Have known hypersensitivity to one of the components of the study or procedural medications;\n10. Have participated in another clinical study at the same time as the present study or within 30 days of Visit 1;\n11. Have a history of drug, medication or alcohol abuse or addiction;\n12. Are females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) who meet any one of the following conditions:\n\n    1. are currently pregnant or,\n    2. have a positive result on the urine pregnancy test at the Screening Visit or,\n    3. intend to become pregnant during the entire course of and 30 days after the study treatment periods, or,\n    4. are breast-feeding or,\n    5. not willing to use highly effective birth control measures, such as: Hormonal contraceptives - oral, implanted, transdermal, or injected and\u002For mechanical barrier methods, during the entire course of and 30 days after the study treatment periods;\n13. Are males with a female partner of child bearing potential where:\n\n    1. the male is not surgically sterilized or,\n    2. where the male partner cannot provide information regarding the female partner's child bearing status or,\n    3. where the child bearing status of the female partner does not meet that of Exclusion Criteria 12; however, the female partner of a male participant will not be required meet Exclusion Criteria 12b.\n14. Have a history of a serious physical or psychiatric disorder that, in the investigator's opinion, could prevent compliance with study procedures or affect study participation;\n15. Have any other surgical or medical condition or finding that in the opinion of the investigator would compromise the subject's safety or participation in the study.","ALL","18 Years","80 Years",{"count":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","rhPRG4-Sjögren's-002 is a prospective multi-center study conducted in Australia to evaluate the safety and efficacy of topically-applied rhPRG4 in subjects with Sjögren's related Dry Eye Disease.",[26],"Sjögren's Syndrome",[28,29],"Sjogrens Syndrome","Dry Eye","RECRUITING","2026-06-17",{"date":33,"type":34},"2026-06-22","ACTUAL",{"date":36,"type":34},"2025-09-17",{"date":38,"type":20},"2026-08",{"name":40,"class":41},"Lubris Bio Pty Ltd","INDUSTRY",6,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100573566","phase-3-a-long-term-extension-study-of-dazodalibep-in-participants-with-sjgrens-syndrome-ss-100573566","NCT06747949","A Long-term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)","A Multicenter, Open-Label, Long-term, Extension Study to Evaluate the Safety and Tolerability of Dazodalibep in Participants With Sjögren's Syndrome (SS)","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all the following criteria apply:\n\n* Participant has provided informed consent before initiation of any study specific activities\u002Fprocedures.\n* Must have been eligible to receive and have received IP (dazodalibep or placebo) and completed the study (through Week 48) in one of the phase 3 SS dazodalibep studies (HZNP-DAZ-301, or HZNP-DAZ-303).\n* Must be able to receive Dose 1 of this LTE study at the Week 48 Visit (+28 days) for the prior pivotal phase 3 SS dazodalibep studies (HZNP DAZ-301, or HZNP DAZ-303).\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Clinically significant active infection at Day 1, in the opinion of the Investigator, including ongoing and chronic infection requiring antibiotics or antiviral medication.\n* Planned participation in another clinical study with an IP or procedure during the LTE study. Other investigational procedures and participation in observational research studies while participating in this study are excluded.\n* Any condition or change in health status observed or reported during the phase 3 SS studies (HZNP-DAZ-301, or HZNP-DAZ-303) that, in the opinion of the Investigator or the Sponsor, would interfere with evaluation and interpretation of participant safety or alter the risk-benefit associated with IP administration.\n* Planned surgeries or hospitalizations that, in the opinion of the Investigator or the Sponsor, would interfere with evaluation and interpretation of participant safety.\n* Individuals who plan to receive live (attenuated) vaccine during the LTE study.\n* Female participants of childbearing potential unwilling to use protocol-specified method of contraception during treatment and for an additional 12 weeks after the last dose of investigational product.\n* Female participants who are pregnant or lactating or planning to become pregnant during the study.\n* Participant has known sensitivity to any of the products or components to be administered during dosing.\n* Participant likely to not be available to complete all protocol-required study visits or procedures, and\u002For to comply with all required study procedures to the best of the participant and investigator's knowledge.\n* History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation.",{"count":51,"type":20},844,[53],"PHASE3","The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.",[26],[57,58,59],"Cluster of differentiation 40 (CD40)","Dazodalibep","AMG 611","2026-04-27",{"date":62,"type":34},"2026-04-28",{"date":64,"type":34},"2025-02-25",{"date":66,"type":20},"2029-12-11",{"name":68,"class":41},"Amgen",174,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":94,"locationsCount":4},"100611723","managed-access-programs-for-vay736-ianalumab-100611723","NCT07244289","Managed Access Programs for VAY736, Ianalumab","Inclusion Criteria:\n\n1. An independent request was received from a licensed physician.\n2. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.\n3. The patient is not eligible or able to enrol in a clinical trial or continue participation in such trial.\n4. There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.\n5. The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).\n6. Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.\n7. Managed Access provision is allowed per local laws\u002Fregulations.","EXPANDED_ACCESS","The purpose of this registration is to list Managed Access Programs (MAPs) related to VAY736, ianalumab",[79,26],"Primary Immune Thrombocytopenia",[81,82,83,84,85,86,87,88,89],"MAP","Managed Access Program","VAY736","ianalumab","Primary Immune Thrombocytopenia (ITP)","Sjögren's Syndrome (SjD)","Expanded Access","Early Access","Compassionate use","AVAILABLE","2026-03-19",{"date":93,"type":34},"2026-03-23",{"name":95,"class":41},"Novartis Pharmaceuticals",{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":106,"phases":4,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":123},"100624825","primary-sjgrens-syndrome-impact-of-quantitative-anti-ro52-antibody-analysis-on-patient-prognosis-and-stratification-ro-sjs-100624825","NCT07414667","Primary Sjögren's Syndrome: Impact of Quantitative Anti-Ro52 Antibody Analysis on Patient Prognosis and Stratification (Ro-SjS)","Primary Sjögren's Syndrome: Impact of Quantitative Anti-Ro52 Antibody Analysis on Patient Prognosis and Stratification","Ro-SjS","Inclusion Criteria :\n\n* Age ≥ 18 years at the time of inclusion,\n* Diagnosis of primary Sjögren's syndrome according to the 2016 ACR\u002FEULAR classification criteria,\n* Quantitative measurement of anti-Ro52 antibodies performed as part of routine care, starting from 2020 (date of routine implementation in the laboratory),\n* Documented medical follow-up in the internal medicine department (or other participating department),\n* No objection to participation in research after being informed according to current regulations (record of non-opposition if applicable).\n\nExclusion Criteria\n\n* Presence of another systemic autoimmune connective tissue disease, including systemic lupus erythematosus, systemic sclerosis, autoimmune myositis, rheumatoid arthritis (except nonspecific arthralgia without classification criteria),\n* History of solid organ or bone marrow transplantation,\n* Severe immunosuppression unrelated to Sjögren's syndrome (e.g., HIV infection, ongoing chemotherapy for active hematologic malignancy),\n* Incomplete or non-exploitable clinical or biological data preventing analysis of primary or secondary endpoints,\n* Individuals under legal protection measures (e.g., guardianship).",{"count":105,"type":20},150,"OBSERVATIONAL","This study aims to evaluate the prognostic value of quantitative anti-Ro52 antibody levels in patients with primary Sjögren's Syndrome. Anti-Ro52 antibodies are frequently detected in this autoimmune disease, but their specific role in disease stratification, systemic involvement, and long-term outcomes remains unclear. Through a prospective cohort analysis, the investigators will investigate the association between anti-Ro52 titers and clinical phenotypes, including extraglandular manifestations, immunological profiles, and disease progression. The objective is to determine whether quantitative assessment of anti-Ro52 antibodies can serve as a biomarker to refine risk stratification and guide personalized management in primary Sjögren's Syndrome.",[109],"Sjögren´s Syndrome",[111],"Anti-Ro52 antibodies","NOT_YET_RECRUITING","2026-02-12",{"date":115,"type":34},"2026-02-17",{"date":117,"type":20},"2026-06-01",{"date":119,"type":20},"2028-06-01",{"name":121,"class":122},"Central Hospital, Nancy, France","OTHER",1,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":135,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":123},"100609265","a-study-of-cd19-ucar-t-cells-in-subjects-with-autoimmune-diseases-100609265","NCT07212322","A Study of CD19 UCAR-T Cells in Subjects With Autoimmune Diseases","A Study to Evaluate the Safety and Efficacy of CD19 UCAR-T Cells in Subjects With Autoimmune Diseases","ET-902-AID01","Inclusion Criteria:\n\n* Male or female, between 18 and 65 years old;\n* Adequate organ functions, defined as follows:\n\nHematological function \\[no transfusion and no use of granulocyte colony-stimulating factor (G-CSF) administration within 2 weeks prior to testing\\]: white blood cells (WBC) ≥3.0×10\\^9\u002FL, absolute neutrophil count (ANC)≥1.0×10\\^9\u002FL, platelet count (PLT)≥50×10\\^9\u002FL (ITP subjects are without restrictions), hemoglobin ≥80 g\u002FL.\n\nCoagulation function: international normalized ratio (INR) ≤ 1.5×upper limit of normal value （ULN）, and activated partial thromboplastin time (APTT) ≤ 1.5×ULN.\n\nHepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤3×(ULN), and total bilirubin ≤1.5×ULN. 4)Renal function: serum creatinine ≤1.5×ULN or creatinine clearance (calculated by Cockcroft Gault formula) ≥ 40 ml\u002Fmin.\n\nCardiac function: New York Heart Association (NYHA) Grade I or II, and left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography (ECHO), with no pericardial effusion, and no clinically significant abnormalities on12-lead electrocardiogram (ECG).\n\nPulmonary function: oxygen saturation ≥92% on room air (without supplemental oxygen), no clinically significant pleural effusion.\n\n* Subjects with fertile partners must agree to use effective contraception throughout the treatment period and for 24 months after treatment, and must refrain from donating eggs\u002Fsperm for assisted reproduction during this period; Female subjects of childbearing potential (excluding those who have undergone sterilization or ≥12 months of menopause) must have negative urine or blood pregnancy test results during screening.\n* Voluntary participates this trial and can comprehend and sign ICF.\n* For subjects with moderate to severe refractory Systemic Lupus Erythematosus:\n\nDiagnosed with SLE according to the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) classification criteria for SLE.\n\nPositive for antinuclear antibody (ANA) (titer ≥1:80) and\u002For anti-dsDNA antibody and\u002For anti-Sm antibody at screening.\n\nSLEDAI-2000 score ≥8 at screening; if points are attributed for low complement and\u002For anti-dsDNA antibody, the SLEDAI-2000 clinical symptom score (excluding points for low complement and\u002For anti-dsDNA antibody) must be ≥6.\n\nA history of at least 6 months of stable standard treatment regimen prior to screening, with failure to achieve LLDAS criteria for at least 2 months before screening. Standard treatment regimen refers to stable use of any of the following medications (alone or in combination):\n\nglucocorticoids, antimalarials, biologics, and other immunosuppressants or immunomodulators.\n\n• For subjects with relapsed\u002Frefractory Systemic Systemic Sclerosis: Diagnosed with systemic sclerosis (SSc) according to the 2013 EULAR\u002FACR classification criteria for SSc.\n\nClassified as diffuse cutaneous or limited cutaneous subtype with a disease duration ≤7 years (from the first occurrence of Raynaud's phenomenon to screening).\n\nIf interstitial lung disease (ILD) is present at screening, forced vital capacity (FVC) must be ≥45% of predicted value, or diffusing capacity for carbon monoxide (DLCO) must be ≥40% of predicted value.\n\nRelapsed\u002Frefractory is defined as: failure to respond to prior conventional therapy or disease relapse after remission. Conventional therapy refers to the use of glucocorticoids combined with at least one immunosuppressive\u002Fimmunomodulatory drug for ≥6 months.\n\n• For subjects with refractory Idiopathic Inflammatory Myopathies: Diagnosed with idiopathic inflammatory myopathy (IIM) with a probability ≥55% according to the 2017 EULAR\u002FACR classification criteria for IIM, and classified as dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), or anti-synthetase syndrome (ASyS) based on age at onset, cutaneous and muscle manifestations, laboratory findings, and muscle biopsy characteristics.\n\nDisease activity\u002Fseverity meets the following criteria: ①Manual Muscle Testing-8 (MMT-8) score ≤141 (total score 150). ②Meets at least two of the following additional abnormal CSMs: Patient Global Assessment of disease activity \\[based on Visual Analog Scale (VAS)\\] score ≥2 (range 0-10); Physician Global Assessment of disease activity VAS score ≥2 (range 0-10); Physician Global Assessment of extra-muscular disease activity VAS score ≥2 (range 0-10); HealthAssessment Questionnaire Disability Index (HAQ-DI) score ≥0.25 (range 0-3); At least one muscle enzyme level \\>1.5 times the upper limit of normal (ULN).\n\nPrevious intolerance or inadequate response to glucocorticoids and at least one immunosuppressant or immunomodulator for the aforementioned autoimmune disease, requiring: Treatment with glucocorticoids and at least one immunosuppressant at known effective doses for at least 3 months.\n\n• For subjects with relapsed\u002Frefractory Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis: Clinically diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) according to the definitions established at the 2012 Chapel Hill Consensus Conference (CHCC).\n\nMeet at least one major item or at least three other items in the Birmingham Vasculitis Activity Score (BVAS) version 3.\n\nTest positive for anti-proteinase 3 (PR3-ANCA) antibody or anti-myeloperoxidase (MPO-ANCA) antibody at screening.\n\nRelapsed\u002Frefractory is defined as: Relapsed AAV subjects: Disease relapse (defined as: presence of at least one major item or at least three other items in BVAS assessment, or occurrence of 1-2 new other items in two consecutive assessments) after achieving initial efficacy (BVAS score of 0 and glucocorticoid dose ≤7.5 mg\u002Fday prednisone or equivalent) following at least 3 months of treatment with glucocorticoids combined with immunosuppressants, with relapse occurring within 12 weeks prior to screening; Refractory AAV subjects: Failure to achieve efficacy (BVAS score of 0 and glucocorticoid dose ≤7.5 mg\u002Fday prednisone or equivalent) after at least 3 months of treatment with glucocorticoids combined with immunosuppressants.\n\n• For subjects with active Sjögren's Syndrome: Diagnosed with Sjögren's syndrome (SS) according to the 2016 EULAR\u002FACR classification criteria.\n\nUnstimulated whole salivary flow rate ≥0.05 mL\u002Fmin or stimulated whole salivary flow rate ≥0.01 mL\u002Fmin at screening.\n\nActive disease defined as: EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ≥5 points.\n\n• For subjects with refractory Antiphospholipid Syndrome: Diagnosed with antiphospholipid syndrome (APS) according to the 2006 Sydney Revised Classification Criteria for APS or the 2023 ACR\u002FEULAR Classification Criteria for APS; Positive for antiphospholipid antibodies (including lupus anticoagulant, anticardiolipin antibodies, and anti-β2 glycoprotein I antibodies) on at least two occasions \\>12 weeks apart; Presence of at least one non-criteria clinical manifestation, including thrombocytopenia, hemolytic anemia, aPL nephropathy, valvular heart disease, and neurological manifestations.\n\n• For subjects with chronic\u002Frefractory Immune Thrombocytopenia: Diagnosed with immune thrombocytopenia (ITP) according to the Chinese Guideline for Diagnosis and Management of Adult Primary Immune Thrombocytopenia (2020 Edition).\n\nPatients who previously received at least one guideline-recommended standard ITP treatment but exhibited inability to maintain response, relapse, intolerance to standard therapy, or insufficient response.\n\nChronic\u002Frefractory definition: Chronic: Persistent thrombocytopenia for ≥12 months; Refractory: Failure to respond to first-line therapies, thrombopoietin receptor agonists, and rituximab; or failure\u002Frelapse after splenectomy; with confirmed ITP diagnosis upon recent reassessment.\n\nExclusion Criteria:\n\n* Patients with a history or concurrent diagnosis of active malignancies, including tumor-associated polymyositis\u002Fdermatomyositis, are excluded. Exceptions include cured or non-recurrent cervical carcinoma in situ for at least 3 years, non-invasive basal cell or squamous cell skin cancer, or localized prostate cancer treated with radical therapy, or ductal carcinoma in situ after radical surgery.\n* Patients who have previously received CD19-targeted drugs, or CAR-T therapy, or any other gene therapy products.\n* Patients with severe pulmonary diseases within the past year, such as moderate to severe pulmonary hypertension (pulmonary artery systolic pressure \\> 50 mmHg on echocardiography), or those requiring oxygen therapy via a reservoir mask or non-invasive\u002Finvasive mechanical ventilation during screening.\n* Patients who have received any of the following medications or treatments within the specified timeframes:\n\nB-cell-depleting therapy within 6 months before screening, assessed by the investigator as not having failed treatment, including anti-CD20, anti-CD22, anti-CD52, anti-CD38 or ant-BCMA monoclonal antibodies or bispecific antibodies.\n\nHigh-dose intravenous immunoglobulin (IVIG) within 3 months before screening. Dialysis or plasmapheresis within 2 months before screening. Glucocorticoid pulse therapy (defined as ≥ 200 mg\u002Fday prednisone or equivalent doses of other glucocorticoids) within 2 months before screening.\n\nUsed telitacicept within 6 weeks before screening, or belimumab within 8 weeks before screening.\n\nThrombopoietin (TPO) or TPO receptor agonists (TPO-RA) or any other medication with a clearly indicated platelet-boosting effect, ortransfusion therapy (including platelet transfusion) within 2 weeks before screening (ITP subjects are without restrictions).\n\n* Patients with a history of severe central nervous system (CNS) disorders history or related symptoms (excluding isolated trigeminal nerve disease) within the past 6 months, including but not limited to: lupus encephalopathy, cerebrovascular diseases, encephalitis, brain injury, aneurysm, cerebellar disorders, organic brain syndrome, Parkinson's disease as well as symptoms such as epilepsy, convulsion, aphasia, dementia.\n* Complicated with severe renal disease, defined as any of the following within 8 weeks before screening:\n\nSevere lupus nephritis \\[defined as urine protein \\> 6g\u002F24h or serum creatinine \\> 1.5×ULN.\n\nCreatinine clearance (Cockcroft Gault formula) \\\u003C 40mL\u002Fmin\\]. Active nephritis requiring treatment that are prohibited per protocol. Requiring hemodialysis or plasmapheresis, or receiving prednisone \\> 100mg\u002Fd or equivalent corticosteroid therapy ≥14 days.\n\n* Patients with severe allergies to any components of the lymphodepletion regimen or CD19 UCAR-T therapy used in this study.\n* Patients who meet any of the following criteria:\n\nPositive for hepatitis B surface antigen (HBsAg) AND positive for hepatitis B core antibody (HBcAb) with detectable HBV DNA in peripheral blood.\n\nPositive for hepatitis C virus (HCV) antibody with detectable HCV RNA. Positive for Treponema pallidum antibody. Positive for HIV antibody.\n\n* Patients with uncontrolled fungal, bacterial, or viral infections, or any other active infections are assessed as inappropriate to participate in the study by investigator .\n* Patients with a history of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell\u002Fbone marrow transplantation.\n* Patients with active tuberculosis (TB) or latent TB infection (defined as positive tuberculin skin test or interferon-gamma release assay results without clinical symptoms or radiographic evidence) at screening;\n* Patients who have experienced any of the following cardiovascular events within 6 months before screening (including but not limited to):\n\nCongestive heart failure, myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary\u002Fperipheral artery bypass grafting.\n\nSevere arrhythmias requiring treatment (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes, etc.). Congenital long QT syndrome and left anterior fascicular block (bifascicular block). Asymptomatic right bundle branch block is permitted for enrollment.\n\nUncontrolled hypertension (systolic blood pressure \\> 160 mmHg and\u002For diastolic blood pressure \\>100 mmHg), history of hypertensive crisis or hypertensive encephalopathy;\n\n* Patients with a history of autoimmune diseases (other than the target indications) that need systemic treatments, including but not limited to: eosinophilic granulomatous with polyangiitis (EGPA), Henoch-Schönlein purpura (HSP), rheumatoid arthritis, cryoglobulinemia vasculitis, inclusion body myositis, anti-glomerular basement membrane disease, Behcet's disease or Takayasu's arteritis, etc..\n* Patients with non-IIM conditions such as drug-induced myopathy, HIV-associated myopathy, thyroid myopathy, or a family history of myopathy.\n* History of catastrophic APS within 3 months prior to screening;\n* Pregnant or lactating women.\n* Patients who have received live vaccines within 6 weeks prior to lymphodepleting chemotherapy.\n* Patients who meet any of the following criteria:\n\nParticipate in other interventional clinical studies, and receipt of any investigational treatment within 3 months before signing the informed consent form.\n\nIntent to participate in another clinical trial during the entire study period. Plan to receive non-protocol-specified treatments for autoimmune diseases.\n\n* Patients with psychiatric disorders including depression or suicidal tendency.\n* Patients deemed by the investigator to have other factors that may make them unsuitable for participation or may affect their ability to complete the study.","65 Years",{"count":134,"type":20},24,[136],"NA","The purpose of this study is to assess the safety and efficacy of CD19 UCAR-T cell therapy in Subjects with autoimmune diseases.",[139,140,141,26,142,143,144],"Systemic Lupus Erythematosus","Idiopahic Inflammatory Myopathies","Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis","Antiphospholipid Syndrome","Immune Thrombocytopenia","Systemic Sclerosis","2025-12-18",{"date":147,"type":34},"2025-12-19",{"date":149,"type":20},"2026-01-30",{"date":151,"type":20},"2027-07-20",{"name":153,"class":122},"Institute of Hematology & Blood Diseases Hospital, China",{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":21,"phases":163,"briefSummary":164,"conditions":165,"keywords":168,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":4},"100615310","phase-2-repeated-mesenchymal-stem-cell-therapy-for-radiation-induced-hyposalivation-and-xerostomia-in-head-and-neck-cancer-survivors-100615310","NCT07290946","Repeated Mesenchymal Stem Cell Therapy for Radiation-Induced Hyposalivation and Xerostomia in Head and Neck Cancer Survivors","MESRIX-more","Inclusion Criteria:\n\n1. Former radiotherapy for squamous cell carcinoma, or adenocarcinoma, of the nasal sinus, larynx, pharynx, and oral cavity\n2. WHO Performance status 0-1\n3. Presence of xerostomia daily\n4. UWS of 0.05 mL\u002Fmin to 0.5 ml\u002Fmin\n5. Age above 18\n6. Informed consent\n7. 0.5 year follow-up of the cancers in 1. with no recurrence\n\nExclusion Criteria:\n\n1. Any malignant cancer diagnosis excluding head and neck cancers\n2. Xerogenic medications at inclusion\n3. Penicillin or streptomycin allergy assessed by health personnel\n4. Any other previous or active disease of the salivary glands (e.g. Sjögren's Disease, sialolothiasis)\n5. Previous submandibular surgery or biopsy\n6. Pregnancy or planned pregnancy until 4 months after second treatment\n7. Breastfeeding\n8. Smoking within the last 6 months\n9. Alcohol abuse within the last 6 months (consumption must not be above 10 units\u002Fweek (Danish National board health alcohol guidelines)",{"count":162,"type":20},100,[23],"Dry mouth leads to debilitating symptoms 24\u002F7. The two primary causes for dry mouth are Sjögrens disease and after radiotherapy of a head and neck cancer. Former clinical trials have investigated mesenchymal stem cell treatment for dry mouth with promising results. However, few of the participants evolved normal salivary flow rate. Therefore, in this randomized clinical trial, two treatments of mesenchymal stem cells are administered, 4 months apart. This has not been done before.\n\nThe hypothesis is that two treatments of mesenchymal stem cells results in a higher salivary flow rate and ameliorate symptoms from dry mouth.",[166,167,109],"Xerostomia Due to Hyposecretion of Salivary Gland","Xerostomia Due to Radiotherapy",[169,170,171,172,173],"Mesenchymal Stem Cell","Sjögren","Radiation","xerostomia","Head and Neck cancer","2025-12-04",{"date":145,"type":34},{"date":177,"type":20},"2025-12",{"date":179,"type":20},"2028-12",{"name":181,"class":122},"Christian von Buchwald",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":132,"enrollmentInfo":189,"targetDuration":4,"studyType":21,"phases":191,"briefSummary":193,"conditions":194,"keywords":4,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":4},"100607175","early-phase-1-mscohi-o-lenses-for-ocular-involvement-in-sjgrens-syndrome-100607175","NCT07185139","MSCohi-O Lenses for Ocular Involvement in Sjögren's Syndrome","Exploratory Clinical Trial of MSCohi-O Lenses for Ocular Involvement in Sjögren's Syndrome","Inclusion Criteria:\n\n* Aged 18-65 years old, including the boundary value, no gender restriction;\n* Subjects meeting the 2016 ACR\u002FEULAR classification criteria for Sjögren's syndrome, and also meet the diagnostic criteria for ocular involvement.\n* Ocular signs and symptoms unresponsive to at least 3 months of conventional therapy, including artificial tears and topical or systemic corticosteroids.\n* Extra-ocular manifestations of Sjögren's syndrome clinically stable.\n* Subjects and their partners agree to use effective non-pharmacological contraception from screening through 6 months after the last dose and have no plans for conception during this period.\n* Willing to participate in the study, understand and sign the informed consent form (ICF).\n\nExclusion Criteria:\n\n* Known allergy to any component of the investigational drug.\n* Active ocular infection.\n* Presence of other significant ocular disease or trauma diagnosed prior to enrollment, including but not limited to glaucoma, uveitis, retinopathy, chemical injury, or thermal burns.\n* History of any ocular surgery within the preceding 6 months, including cataract surgery.\n* Participation in another interventional clinical study.\n* Use of any ophthalmic medication that may interfere with the study outcomes, such as other stem-cell-derived products.\n* Having serious underlying diseases of the heart, brain vessels, liver, kidneys, and hematopoietic system.\n* Pregnant or lactating women; women of childbearing potential must employ an effective contraceptive method (e.g., intrauterine device, oral contraceptive, or condom) during the study and for at least 3 months after the final dose of study drug.\n* Subjects deemed unsuitable for participation in this trial by the investigator.",{"count":190,"type":20},12,[192],"EARLY_PHASE1","This study is aSingle-center, multiple-dosing, prospective, nonrandom, single-arm trial.",[26],{"date":196,"type":34},"2025-09-22",{"date":198,"type":20},"2025-09-12",{"date":200,"type":20},"2026-09-30",{"name":202,"class":41},"Guangdong ProCapZoom Biosciences Co., Ltd.",{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":132,"enrollmentInfo":210,"targetDuration":4,"studyType":21,"phases":211,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":219,"locationsCount":4},"100607754","early-phase-1-exosomes-in-patients-with-ocular-involvement-of-sjgrens-syndrome-100607754","NCT07192666","Exosomes in Patients With Ocular Involvement of Sjögren's Syndrome","Exploratory Clinical Trial of Exosomes in Patients With Ocular Involvement of Sjögren's Syndrome","Inclusion Criteria:\n\n* Aged 18-65 years old, including the boundary value, no gender restriction;\n* Subjects meeting the 2016 ACR\u002FEULAR classification criteria for Sjögren's syndrome, and also meet the diagnostic criteria for ocular involvement.\n* The ocular involvement symptoms and signs of these patients cannot be relieved after at least 3 months of conventional therapy, including artificial tears and topical or systemic corticosteroids.\n* Extra-ocular manifestations of Sjögren's syndrome clinically stable.\n* Subjects and their partners agree to use effective non-pharmacological contraception from screening through 6 months after the last dose and have no plans for conception during this period.\n* Willing to participate in the study, understand and sign the informed consent form (ICF).\n\nExclusion Criteria:\n\n* Known allergy to any component of the investigational drug.\n* Active ocular infection.\n* Presence of other significant ocular disease or trauma diagnosed prior to enrollment, including but not limited to glaucoma, uveitis, retinopathy, chemical injury, or thermal burns.\n* History of any ocular surgery within the preceding 6 months, including cataract surgery.\n* Participation in another interventional clinical study.\n* Use of any ophthalmic medication that may interfere with the study outcomes, such as other stem-cell-derived products.\n* Having serious underlying diseases of the heart, brain vessels, liver, kidneys, and hematopoietic system.\n* Pregnant or lactating women; women of childbearing potential must employ an effective contraceptive method (e.g., intrauterine device, oral contraceptive, or condom) during the study and for at least 3 months after the final dose of study drug.\n* Subjects deemed unsuitable for participation in this trial by the investigator.",{"count":190,"type":20},[192],"This study is a single-center, multiple-dosing, prospective, nonrandom, single-arm trial.",[26],{"date":215,"type":34},"2025-09-25",{"date":217,"type":20},"2025-09-15",{"date":200,"type":20},{"name":202,"class":41}]