[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"systemic-sclerosis-ssc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:systemic-sclerosis-ssc":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,66,0,25,[9,42,76,104,133,160,190,220,263,302,330,356,393,416,439,459,498,522,543,567,593,613,642,662,685],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"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},"100623868","systemic-sclerosis-diet-for-gastrointestinal-symptoms-100623868",false,"NCT07402226","Systemic Sclerosis DIet for GastrointESTinal Symptoms","SSc-DIGEST Trial: Systemic Sclerosis DIet for GastrointESTinal Symptoms Randomized Controlled Trial of Low FODMAP, CDED, and NICE Diets for Gastrointestinal Symptoms in Systemic Sclerosis","DIGEST","Inclusion Criteria:\n\n* Diagnosis of systemic sclerosis (SSc) as per ACR\u002FEULAR classification criteria\n\n  .• Self-reported moderate to severe gastrointestinal bloating or distension, with a UCLA SCTC-GIT 2.0 bloating Scale score ≥2.00 on (0.00-3.00 scale) at screening.\n* Willingness and ability to comply with dietary intervention and study procedures.\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis) or celiac disease.\n* Use of systemic antibiotics within 4 weeks prior to baseline.\n* History of gastrointestinal surgery (other than cholecystectomy or appendectomy unless in the last 3 months).\n* Severe cognitive impairment or psychiatric illness that would limit ability to follow dietary instructions.\n* Known allergy or intolerance to major components of any of the study diets (e.g., lactose, gluten) unless manageable within diet framework.\n* Current or recent (within 3 months) dietary intervention for managing GI symptoms (e.g. gluten-free diet, low FODMAP diet, etc.).\n* Clinically significant self-reported (≥10 percent weight loss) in the last 3 months\n* BMI less than 20\n* Ongoing tube feeds or TPN\n* Participating in another interventional trial\n* Pregnancy or lactation, or planning pregnancy in the next 6 months","ALL","18 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"NA","This research will evaluate the effect of diets on bloating\u002Fdistention, assess changes in abdominal pain, and overall gastrointestinal symptom burden in Systemic Sclerosis. The researchers will do this by comparing outcomes of people assigned to 3 different diets. Following the research specifics of the diets will be available upon contact with the details listed below.",[28],"Systemic Sclerosis (SSc)","RECRUITING","2026-06-30",{"date":32,"type":33},"2026-07-01","ACTUAL",{"date":35,"type":33},"2026-03-16",{"date":37,"type":22},"2027-04",{"name":39,"class":40},"University of Michigan","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100629321","phase-1-controlling-hyperactive-immunity-with-long-lived-lymphocytes-100629321","NCT07473154","Controlling Hyperactive Immunity With Long-lived Lymphocytes","Phase I\u002FII Study of QEL-005 in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) and in Patients With Difficult to Treat Rheumatoid Arthritis (D2TRA).","CHILL","Inclusion Criteria:\n\n* Participants must be at least 18 years of age at the time of signing the informed consent.\n* Up to date vaccination status and no planned vaccinations for post 3 months infusion\n* Adequate haematological, liver and renal function\n* Willing to undergo annual influenza vaccination\n* Willing to enter a 15-year follow-up\n* Eastern Cooperative Oncology Group (ECOG) performance status grade \\\u003C 3\n* Able and willing to use a highly effective method of contraception\n* Stable dose of steroid prior to screening\n\nSpecific inclusion criteria for participants with difficult to treat rheumatoid Arthritis (D2TRA) only:\n\n* Diagnosis of Rheumatoid Arthritis (RA) per 2010 ACR-EULAR criteria\n* Diagnosis of D2TRA per 2021 EULAR criteria\n* Evidence of clinically active disease a defined by validated clinical or laboratory results consistent with standard definitions of active RA\n* Evidence of inflammation in target joints used for the DAS28 CRP assessment\n\nSpecific inclusion criteria for participants with diffuse cutaneous systemic sclerosis (dcSSc) only:\n\n* Diagnosis of dcSSc as per the 2013 ACR-EULAR criteria\n* Serologically positive for antinuclear antibodies\n* Failure to respond sufficiently to immunomodulatory disease modifying anti-rheumatic drugs (DMARDs).\n* Skin involvement with a total modified Rodnan Skin Score of at least 15\n* Evidence of lung fibrosis based on imaging or pulmonary function testing\n* Evidence of active disease based on a validated SSc activity assessment\n\nExclusion Criteria:\n\n* Presence of a significant medical condition(s), or clinically significant laboratory abnormality\n* History or concern of autoimmune diseases other than those under study\n* Active infection, or recurrent chronic infection requiring intervention\n* Immunodeficiency or receiving immunoglobulin replacement therapy\n* Past or current infection with hepatitis B or C, tuberculosis, syphilis, or HIV\n* Clinically significant cardiac dysfunction or severe pulmonary impairment\n* Use of investigational agents within a pre-defined period prior to study screening\n* Received a previous cell therapy\n* Received certain B cell related experimental therapies in a clinical trial with the past year\n* Any solid organ, bone marrow or stem cell transplant\n* History of malignancy in the past 5 years\n* Receiving prohibited medication that cannot be stopped at screening",{"count":51,"type":22},16,[53,54],"PHASE1","PHASE2","This study is a Phase 1\u002F2, open-label clinical trial to test an experimental treatment called QEL-005 in adults with two autoimmune conditions: diffuse cutaneous systemic sclerosis (dcSSc) and difficult-to-treat rheumatoid arthritis (D2TRA). The main goals are to find out whether QEL-005 is safe, how well people tolerate it, and whether it may help reduce disease activity or improve symptoms.\n\nQEL-005 is made from a participant's own white blood cells (autologous cells). These cells are collected and then changed in a laboratory using genetic methods to create specialized immune cells called CAR-T regulatory cells that target a protein on B cells called CD19. These modified cells are then given back to the participant by intravenous (IV) infusion.\n\nTo take part, eligible participants will first have a procedure called leukapheresis, where some of their white blood cells are removed from the blood. The study team will use these cells to manufacture QEL005. After QEL005 is ready, participants will receive an IV infusion of their modified cells, stay in hospital overnight for monitoring, and will then be followed closely in the clinic.\n\nThroughout the trial, participants will have regular safety checks, which may include blood tests, imaging scans, questionnaires about symptoms and daily functioning, and biopsies taken from involved tissues, to help understand how QEL005 is working in the body. Detailed follow up will be for 1 year after QEL-005 infusion, and there is long-term follow up for a total of 15 years, which is standard for cell therapies. The information from this Phase 1\u002F2 study will help determine an appropriate dose and dosing schedule of QEL005 for future studies.",[57,58,28,59],"Diffuse Cutaneous Systemic Sclerosis","Rheumatoid Arthritis (RA)","Autoimmune Rheumatologic Disease",[61,62,63,64,65],"Regulatory T cells","Autologous","Genetically modified cells","Treg","Chimeric antigen receptor (CAR)","2026-06-29",{"date":30,"type":33},{"date":69,"type":33},"2026-04-10",{"date":71,"type":22},"2028-08",{"name":73,"class":74},"Quell Therapeutics Limited","INDUSTRY",6,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":88,"conditions":89,"keywords":94,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":41},"100633412","early-phase-1-mts109-in-patients-with-refractory-autoimmune-diseases-100633412","NCT07526350","MTS109 in Patients With Refractory Autoimmune Diseases","A Study on the Safety, Tolerability and Efficacy of MTS109 Injection in the Treatment of Moderate to Severe Refractory Autoimmune Diseases, an Investigator-Initiated Trial","Inclusion Criteria:\n\n1\\) The subject or his\u002Fher legal representative has voluntarily signed a written informed consent form and is willing and able to comply with study procedures. 2) Aged 18 to 65 years (inclusive) at the time of signing the informed consent form, with no gender restriction.\n\n3\\) Subjects with SLE must meet the following criteria: a) Meet the 2019 EULAR\u002FACR classification criteria for systemic lupus erythematosus (SLE); b) SLEDAI-2K score ≥6, with at least 1 BILAG-2004 organ domain score of Grade A (severe manifestation) or 2 Grade B (moderate manifestation), or both; or SLEDAI-2000 score ≥8; c) Meet the definition of refractory and relapsing disease: inadequate response to conventional therapy for more than 6 months, or disease flare after remission. Conventional therapy is defined as: glucocorticoids plus at least 2 of the following immunomodulatory agents: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, and telitacicept.\n\n4\\) Subjects with idiopathic inflammatory myopathy (IIM) must meet the following criteria: a) Meet the 2017 EULAR\u002FACR classification criteria for idiopathic inflammatory myopathies (including dermatomyositis \\[DM\\], polymyositis \\[PM\\], anti-synthetase syndrome \\[ASS\\], and necrotizing myopathy \\[NM\\]); b) Positive for myositis-specific antibodies; c) Moderate-to-severe IIM during screening, defined as: MMT-8 ≥142 with active interstitial lung disease (ILD) (ground-glass opacity on HRCT); OR MMT-8 \\\u003C142 and at least 2 of the following: Physician's Global Assessment (PGA, VAS) ≥2 cm (10-cm VAS scale); Patient's Global Assessment (PtGA, VAS) ≥2 cm (10-cm VAS scale); Health Assessment Questionnaire Disability Index (HAQ-DI) \\>0.25; One or more muscle enzymes (CK, LDH, AST, ALT) ≥1.5 × upper limit of normal (ULN); d) Meet the definition of refractory, relapsing, or progressive disease: Refractory: inadequate response to conventional therapy for more than 6 months, or disease flare after remission; conventional therapy as defined for SLE; Progressive: worsening myositis or rapidly progressive interstitial lung disease.\n\n5\\) Subjects with systemic sclerosis (SSc) must meet the following criteria: a) Meet the 2013 ACR classification criteria for systemic sclerosis; b) Positive for SSc-related specific antibodies; c) Meet the definition of refractory or progressive disease: Refractory: inadequate response to conventional therapy for more than 6 months, or disease flare after remission; conventional therapy as defined for SLE; Progressive: rapid skin progression (increase in mRSS \\>25%); or progressive lung disease (decrease in FVC ≥10%, or decrease in FVC \\>5% with decrease in DLCO ≥15%).\n\n6\\) Subjects with ANCA-associated vasculitis (AAV) must meet the following criteria: a) Meet the 2022 ACR\u002FEULAR classification criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis; b) Positive for ANCA-associated antibodies (MPO-ANCA or PR3-ANCA); c) Birmingham Vasculitis Activity Score (BVAS) ≥15 (total score 63), indicating active vasculitis; d) Meet the definition of refractory: inadequate response to conventional therapy for more than 6 months, or disease flare after remission; conventional therapy as defined for SLE.\n\n7\\) Subjects with Sjögren's syndrome (SS) must meet the following criteria: a) Meet the 2002 AECG criteria for primary Sjögren's syndrome or the 2016 ACR\u002FEULAR classification criteria; b) Disease activity ESSDAI ≥6; c) Positive for anti-SSA\u002FRo antibody; d) Meet the definition of refractory: inadequate response to conventional therapy for more than 6 months, or disease flare after remission; conventional therapy as defined for SLE.\n\n8\\) Screening laboratory results meet the following criteria (excluding abnormalities related to the study disease): a) Neutrophil count ≥1.5 ×10⁹\u002FL; b) Hemoglobin ≥80 g\u002FL; platelet count ≥50 ×10⁹\u002FL; c) Alanine aminotransferase (ALT) ≤3 × ULN; aspartate aminotransferase (AST) ≤3 × ULN (unless elevation is judged by the investigator to be related to PM or DM); total bilirubin (TBIL) \\\u003C2 × ULN (for subjects with Gilbert syndrome, direct bilirubin \\[DBIL\\] ≤1.5 × ULN); d) Creatinine clearance ≥30 mL\u002Fmin; e) Activated partial thromboplastin time (APTT) ≤1.5 × ULN; prothrombin time (PT) ≤1.5 × ULN; f) Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%, with no clinically significant electrocardiogram (ECG) abnormalities; g) Baseline oxygen saturation \\>92% while breathing room air.\n\n9\\) Female subjects of childbearing potential: negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test at screening.\n\n10\\) Male subjects with female partners and female subjects of childbearing potential agree to use effective contraceptive methods (e.g., oral contraceptives, intrauterine device, condom) from screening until at least 1 year after the last dose of MTS109.\n\nExclusion Criteria:\n\n1. SLE subjects: a) Drug-induced SLE; b) Subjects with lupus crisis, or who require medications prohibited by the protocol due to comorbidities, or who are considered ineligible by the investigator.\n2. IIM subjects: a) Subjects with documented inclusion body myositis (IBM), drug-induced PM or DM, malignancy-associated PM or DM, or non-inflammatory myopathy (e.g., muscular dystrophy); b) Uncontrolled extramuscular involvement related to PM or DM: ILD: FVC \\\u003C55% or requiring oxygen therapy (FVC ≥55% to be evaluated for eligibility by the lead investigator); Severe dysphagia that, in the investigator's judgment, would increase subject risk by participating in the clinical trial; Severe cardiac manifestations (e.g., congestive heart failure, arrhythmia, treatable conduction abnormality, or myocardial infarction) that, in the investigator's judgment, would increase subject risk by participating in the clinical trial.\n3. SSc subjects: a) Uncontrolled severe pulmonary arterial hypertension (PAH) related to SSc; b) Rapidly progressive lower gastrointestinal tract (small and large intestine) involvement related to SSc requiring parenteral nutrition; active gastric antral vascular ectasia; c) Uncontrolled or rapidly progressive ILD with oxygen saturation (SaO2) \\\u003C92% on room air; or requiring mechanical ventilatory support within 1 year prior to signing informed consent.\n4. AAV subjects: a) Crescentic glomerulonephritis, acute polyneuritis, or central nervous system (CNS) involvement other than AAV at screening; b) Life-threatening severe vasculitis (including diffuse alveolar hemorrhage, respiratory failure, intestinal perforation or massive bleeding, cerebral vasculitis, cardiac vasculitis, etc.); c) Secondary vasculitis (e.g., SLE, Henoch-Schönlein purpura, drug-induced, malignancy-associated, infection-induced, primary immunodeficiency, etc.).\n5. SS subjects: a) Poorly controlled severe systemic primary Sjögren's syndrome (pSS) manifestations at baseline that, in the investigator's assessment, may place the subject at excessive risk; b) Secondary Sjögren's syndrome with other confirmed autoimmune diseases (e.g., rheumatoid arthritis, SLE, scleroderma, inflammatory bowel disease); c) Subjects requiring regular use of medications known to cause dry mouth\u002Fdry eye as common major side effects; d) Subjects with other diseases that may interfere with efficacy assessment of primary Sjögren's syndrome, such as inflammatory bowel disease, gout, sarcoidosis, amyloidosis, IgG4-related disease, etc. All subjects:\n6. Subjects with a history of severe hypersensitivity or anaphylaxis;\n7. Subjects with contraindications or hypersensitivity to any component of the investigational product;\n8. Subjects with any of the following cardiac diseases: a) New York Heart Association (NYHA) Class III or IV congestive heart failure; b) Myocardial infarction or coronary artery bypass grafting within 6 months prior to screening; c) Clinically significant ventricular arrhythmia at screening, history of unexplained syncope not due to vasovagal reaction or dehydration, corrected QT interval (QTc) \\>480 ms, or history of severe non-ischemic cardiomyopathy;\n9. Subjects with any active malignancy or history of malignancy within 5 years prior to screening, excluding: early-stage tumors treated with curative intent (carcinoma in situ or Stage I tumor, non-ulcerated primary melanoma \\\u003C1 mm depth without lymph node involvement), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, or breast carcinoma in situ treated with potentially curative therapy;\n10. Subjects with any other known autoimmune disease other than the study disease;\n11. Subjects requiring long-term use of anticoagulants affecting coagulation function;\n12. Subjects with clinically significant bleeding symptoms or obvious bleeding tendency within 6 months prior to screening, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc.; hereditary or acquired bleeding and thrombotic tendency (e.g., hemophilia, coagulopathy, hypersplenism, etc.); subjects with arterial or venous thrombotic events within 6 months prior to screening, such as cerebrovascular disease (including cerebral hemorrhage, cerebral infarction, etc.), deep vein thrombosis and\u002For pulmonary embolism;\n13. Subjects with any severe underlying disease at screening, e.g.: a) Evidence of uncontrolled infection or viral, bacterial, fungal, or other infection treated with systemic intravenous antibiotics; b) Evidence of clinically significant dementia or altered mental status; c) History of any other central nervous system disease or neurodegenerative disease, such as epilepsy, seizure, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, psychosis;\n14. Subjects with positive screening results for any of the following: a) Positive human immunodeficiency virus (HIV) antibody; b) Positive hepatitis B surface antigen (HBsAg); or positive hepatitis B core antibody (HBcAb) with HBV-DNA above the lower limit of detection of the assay; c) Positive hepatitis C virus (HCV) antibody with HCV RNA above the lower limit of detection of the assay; d) Active syphilis (excluding false-positive due to disease);\n15. Subjects with positive plasma cytomegalovirus (CMV) DNA or plasma Epstein-Barr virus (EBV) DNA (viral active);\n16. Subjects with active tuberculosis or untreated latent tuberculosis prior to screening;\n17. Subjects who received other investigational drugs within 4 weeks prior to signing informed consent form (ICF), or for whom the time from the last dose of a previous investigational drug to the date of signing ICF is less than 5 elimination half-lives of that drug (whichever is longer);\n18. Subjects who received plasmapheresis or immunoadsorption therapy within 4 weeks prior to dosing;\n19. Subjects who received B-cell targeted therapy within 6 months prior to dosing, including but not limited to belimumab, telitacicept, etc.;\n20. Subjects who received biologic therapy such as anti-TNF-α antibody within 12 weeks prior to dosing;\n21. Subjects who received tacrolimus, cyclosporine, azathioprine, mycophenolate mofetil, mycophenolic acid, methotrexate, etc., within 2 weeks prior to dosing;\n22. Subjects who received neonatal Fc receptor (FcRn) antagonist therapy (e.g., efgartigimod) within 3 weeks prior to dosing;\n23. Subjects who received complement inhibition therapy (e.g., eculizumab) within 3 weeks prior to dosing;\n24. Subjects who received live attenuated vaccine or mRNA vaccine within 8 weeks prior to enrollment, or inactivated vaccine within 2 weeks prior to enrollment;\n25. Subjects who underwent major surgery within 8 weeks prior to screening or plan to undergo surgery during the study;\n26. Subjects with a history of organ\u002Fbone marrow\u002Fperipheral blood\u002Fumbilical cord blood transplantation;\n27. Subjects who previously received CAR-T product therapy targeting any target;\n28. Subjects with any condition that, in the investigator's judgment, may prevent completion of the entire study, interfere with study results, or make participation in the study not in the subject's best interest.","65 Years",{"count":85,"type":22},15,[87],"EARLY_PHASE1","This is the first-in-human trial of MTS109 (mRNA-LNP). The goal of this clinical trial is to evaluate the safety, tolerability of intravenous injection of MTS109 in moderate to severe autoimmune diseases.",[90,91,28,92,93],"Systemic Lupus Erythematosus","Idiopathic Inflammatory Myopathies","ANCA-Associated Vasculitis (AAV)","Sjogren's Syndrome (SS)",[95],"MTS109","2026-06-26",{"date":30,"type":33},{"date":99,"type":33},"2026-03-24",{"date":101,"type":22},"2029-04-01",{"name":103,"class":40},"Shanghai Changzheng Hospital",{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":83,"enrollmentInfo":111,"targetDuration":4,"studyType":23,"phases":113,"briefSummary":114,"conditions":115,"keywords":119,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100641434","phase-1-a-phase-12-study-of-pro-203-in-healthy-volunteers-and-participants-with-systemic-sclerosis-100641434","NCT07641634","A Phase 1\u002F2 Study of PRO-203 in Healthy Volunteers and Participants With Systemic Sclerosis.","A Two-part, Phase 1\u002F2, Randomized, Double-blind, Placebo-controlled, Single-ascending-dose Study of PRO-203 in Healthy Adult Volunteers Followed by an Open-label, Single-ascending-dose With Priming Study of PRO-203 in Participants With Systemic Sclerosis","Key Inclusion Criteria (All Participants)\n\n* Is male or female, age 18 to 65 years, inclusive, at Screening.\n* Able to provide Informed Consent.\n* Absolute B cell count \\> 25 cells\u002FuL.\n\nAdditional Inclusion for Part 1 (Closed to Enrollment)\n\n* In good general health, determined by no clinically significant findings in the of the investigator from medical history, physical examination, 12-lead ECG, clinical laboratory findings, and vital signs at Screening and Day -1 (participants with Gilbert's disease with associated abnormalities of liver function tests are eligible for enrollment).\n* Up to date vaccination status per local guidelines (including but not limited to influenza vaccine, COVID booster and hepatitis B vaccine).\n\nAdditional Inclusion for Part 2\n\n* Fulfill 2013 ACR\u002F EULAR criteria for classification of SSc with a total score of ≥ 9.\n* Active disease defined as at least two of the following at screening:\n* Disease duration ≤ 2 years (since onset of first-non-Raynaud-symptom), or\n* Elevated acute phase reactant levels (CRP ≥ 6 mg\u002FL, erythrocytes sedimentation rate \\[ESR\\] ≥ 28 mm\u002F1h, or platelet count ≥ 330,000\u002FµL), or\n* Baseline mRSS ≥10 with evidence of progression, defined as mRSS increase at least 3 units, or involvement of 1 new body area and mRSS increase at least 2 units, or involvement of 2 new body areas (each within the previous 6 months), or\n* ≥ 1 tendon friction rub, or\n* Elevation of CK or aldolase \\> 2 × the upper limit of normal (ULN) consistent with SSc-related myopathy, or\n* Progressive fibrosing interstitial lung disease (ILD) as defined by at least one of the following criteria at any time within the prior 2 years:\n\n  1. relative decline in forced vital capacity (FVC) % predicted ≥ 10%, or\n  2. relative decline in FVC % predicted ≥ 5% to \\\u003C10% and worsened respiratory symptoms, or\n  3. relative decline in FVC % predicted ≥ 5% to \\\u003C10% and increased extent of fibrosis on high-resolution computed tomography (HRCT), or\n  4. worsened respiratory symptoms and increased extent of fibrosis on HRCT\n* Intolerant or refractory to at least 1 line of standard therapy, including methotrexate, azathioprine, IVIG, mycophenolic acid derivatives, cyclophosphamide, TNF-inhibitors, rituximab, or tocilizumab.\n\nKey Exclusion Criteria (All Participants)\n\n* Any clinically significant underlying illness in the opinion of the investigator.\n* Active infection within 4 weeks prior to screening. Participants receiving IV antibiotics or having received IV antibiotics within 14 days prior to enrollment are excluded.\n* Positive QuantiFERON-Gold TB test at screening.\n* Plan to receive live, attenuated vaccine after signing ICF (inactive vaccines, such as the flu vaccine, are allowed).\n* Evidence of malignant disease or malignancies diagnosed within the previous 5 years (except for treated local basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that had been excised and cured).\n* Currently enrolled in another investigational device or drug study, or less than 30 days or 5 half-lives of the prior investigational agent (whichever is longer) have passed since ending another investigational device or drug study or plans to enroll in another investigational device or drug study during the course of this study.\n* Social smokers e.g. up to 10 cigarettes per week (or equivalent amounts of nicotine containing products) and willing to abstain during inpatient stay, are allowed\n\nAdditional Exclusion Criteria for Part 1 (Closed to Enrollment)\n\n* Use of any prescription medication within 14 days and OTC medications, vitamins, herbal medications (e.g., St. John's wort), or cannabis, except for contraceptive medications and as needed (prn) acetaminophen\u002Fparacetamol (not exceeding 2 grams\u002Fday) within 7 days prior to administration of the study drug and throughout the study.\n\nAdditional Exclusion Criteria for Part 2\n\n* Rheumatic autoimmune disease other than SSc.\n* Positive anti-centromere antibodies.\n* Pulmonary disease with FVC ≤ 45% of predicted, or DLCO ≤ 35% of predicted.\n* Class 2 or higher pulmonary arterial hypertension or evidence of other moderately severe pulmonary disease.\n* Renal crisis within 6 months prior to Screening.\n* Prior treatment with cellular immunotherapy (eg, CAR-T) or gene therapy product directed at any target.\n* Previous treatment with chlorambucil, bone marrow transplantation, or total lymphoid irradiation.\n* Previous treatment with thalidomide, anti-thymocyte globulin, plasmapheresis, or extracorporeal photopheresis.\n* Unable to washout current immunosuppressive therapy within 2 months\n* Has received anti-CD19 or CD20 therapies, within 6 months prior to start of therapy\n* Plan to receive live or live-attenuated vaccines within 8 weeks prior to first dose of study drug and during treatment until B cell reconstitution to 80% of baseline (inactive vaccines, such as the flu vaccine, are allowed)",{"count":112,"type":22},44,[53,54],"A two-part study of PRO-203 administered subcutaneously in healthy adult volunteers and participants with Systemic Sclerosis (SSc).",[116,28,117,118],"Healthy Volunteers","Scleroderma, Systemic","Scleroderma",[120,121,118,122],"Systemic sclerosis","SSc","B cell depletion","2026-06-16",{"date":125,"type":33},"2026-06-18",{"date":127,"type":33},"2025-10-27",{"date":129,"type":22},"2028-01",{"name":131,"class":74},"Prolium Bioscience, Inc",3,{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":140,"sex":18,"minAge":19,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":23,"phases":143,"briefSummary":144,"conditions":145,"keywords":146,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":41},"100642702","tissue-modeling-in-systemic-sclerosis-using-induced-pluripotent-stem-cells-ipscs-100642702","NCT07650565","Tissue Modeling in Systemic Sclerosis Using Induced Pluripotent Stem Cells (iPSCs)","hiPSSS","Inclusion Criteria:\n\n* Age between 18 and 85 years\n* Diagnostic criteria for the three groups:\n\n  \\> Severe SSc group:\n* Diagnosis of diffuse\u002Fsevere systemic sclerosis by a physician for at least 12 months based on recommendations (according to ACR criteria)\n* Known positivity of autoimmunity directed against Scl-70\n\n  \\> Localized\u002Fnon-complicated SSc group:\n* Diagnosis of systemic sclerosis by a physician for at least 12 months based on recommendations (according to ACR criteria)\n* Documentation of the absence of major vital organ involvement\n* Negative anti-Scl-70 autoantibodies but presence of other systemic sclerosis-related autoantibodies\n\n  \\> Healthy subjects group:\n* First-degree relative of a patient recruited in one of the systemic sclerosis groups (father, mother, brother, sister, adult child)\n* Absence of systemic autoimmune diseases\n\nExclusion Criteria:\n\n* Other diseases that may affect erythroid progenitor cells (non-exhaustive: active cancer, hematological malignancy, chemotherapy targeting DNA)\n* Patient in an exclusion period determined by another protocol\n* Protected populations according to French public health law (pregnant or breastfeeding women; individuals deprived of liberty by judicial or administrative decision; adults under legal protection (any form of guardianship))\n* Absence of informed consent\n* Not affiliated with a national health insurance system",true,"85 Years",{"count":51,"type":22},[25],"The objective of the study is to establish an in vitro model using iPSCs to test the hypotheses developed.\n\nThe primary objective is to generate, via the SAFE-IPS platform, 8 iPSC lines derived from blood samples taken from:\n\n* Two patients with severe\u002Fdiffuse SSc with multi-organ involvement (with anti-SCl-70 autoantibodies)\n* Two of their healthy close relatives\n* Two patients with uncomplicated SSc with localized involvement (with non-SCl-70 autoantibodies)\n* Two of their healthy close relatives\n\nThese 8 cell lines will be differentiated by several teams at the FHU REGENHAB into:\n\n* Immune cells (monocytes\u002Fmacrophages, neutrophils, dendritic cells, B\u002FT lymphocytes)\n* Mesenchymal stromal cells\n* Myocardial cells\n* Skin cells (fibroblasts)\n* Synovial cells\n* Bronchial cells\n* Endothelial cells\n\nThis project aims to map cellular and tissue heterogeneity using iPSC lines obtained from patients with both severe and mild SSc, employing single-cell RNA-seq under various pathological conditions, with and without autologous (or even heterologous) autoimmune stimulation. For example, the percentages of different cell types comprising a tissue in these various situations will be calculated. Comparisons will be made with control groups using healthy iPSC lines by recruiting healthy subjects with the same genetic profile and gender as the patients.",[28],[147,148,149,150],"Systemic Sclerosis","Induced Pluripotent Stem Cells","Autoimmune Disease","Tissue Modeling","NOT_YET_RECRUITING","2026-06-11",{"date":123,"type":33},{"date":155,"type":22},"2026-09",{"date":157,"type":22},"2028-03",{"name":159,"class":40},"University Hospital, Montpellier",{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":23,"phases":169,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":41},"100570561","phase-1-us-zamto-cel-autoimmune-diseases-100570561","NCT06708845","US Zamto-cel Autoimmune Diseases","A Phase I Multicohort Trial of Zamtocabtagene Autoleucel (Zamto-Cel) in Subjects With Severe Refractory Autoimmune Diseases","General Key Inclusion\u002FExclusion Criteria Across All Cohorts\n\nInclusion Criteria:\n\n•Confirmed diagnosis of autoimmune disease (SLE-Non-renal, SLE-LN, SSc\u002F dcSSc)\n\nExclusion Criteria:\n\n* Prior gene therapy treatment\n* Active malignancy within past 5 years\n* Significant active fungal or bacterial infection\n* History or presence of CNS lupus or other CNS disease\n* eGFR \\\u003C 45 mL\u002Fmin\u002F1.73 m\\^2\n* Total bilirubin outside the normal range (unless congenital hyperbilirubinemia such as Gilbert syndrome has been confirmed).\n\nSystemic Lupus Erythematosus-Non-renal Key Inclusion\u002FExclusion Criteria\n\nInclusion Criteria:\n\n* Positive for at least 1 of the following autoantibodies at Screening: anti- double stranded DNA or anti-Smith\n* Systemic Lupus Erythematosus Disease Activity Index-2000 score ≥ 8 AND at least 1 British Isles Lupus Assessment Group (BILAG)-2004 Class A (severe manifestation) organ scores\n* Inadequate response to glucocorticoids and to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolic acid or its derivatives, belimumab, azathioprine, anifrolumab, methotrexate, rituximab, or obinutuzumab\n\nExclusion Criteria:\n\n* Subjects with neuropsychiatric SLE.\n* Drug-induced SLE.\n\nSystemic Lupus Erythematosus - Lupus Nephritis Key Inclusion\u002FExclusion Criteria\n\nInclusion Criteria:\n\n* Positive for at least 1 of the following autoantibodies at Screening: anti- double stranded DNA or anti-Smith\n* Confirmed LN diagnosis by kidney biopsy during screening or within the previous 6 months, with severe active phase of the disease.\n* Progressing despite maintenance on maximally tolerated doses of renin- angiotensin system (RAS) blocking agents, unless allergic to or intolerant of ACE inhibitors and ARBs\n* Inadequate response to glucocorticoids and hydroxychloroquine and at least 1 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolic acid derivatives, belimumab, azathioprine, methotrexate, rituximab, obinutuzumab, calcineurin inhibitor (cyclosporin, tacrolimus or voclosporin)\n\nExclusion Criteria:\n\n•Evidence of Rapidly progressive glomerulonephritis (defined as a doubling of serum creatinine within 3 months prior to enrollment) or as determined by the study investigator.\n\nSystemic Sclerosis\u002FDiffuse Cutaneous Systemic Sclerosis Cohort Key Inclusion\u002F Exclusion Criteria\n\nInclusion Criteria:\n\n* Active disease defined as:\n* Modified Rodnan skin score (mRSS) ≥ 16 units, in the prior 6 months, with 1 or more of the following:\n\n  * Increase in mRSS by ≥ 3 units or 10%\n  * Involvement of 1 new body area with increase in mRSS by ≥ 2 units\n  * Involvement of 2 new body areas with increase by ≥ 1 mRSS unit OR\n* Progressive interstitial lung disease (ILD) defined as:\n\n  \\- Worsening of respiratory symptoms and an increased extent of fibrosis evaluated by high-resolution computed tomography\n* Lack of response to standard therapy (e.g., failure of ≥ 2 immunosuppressive therapies)\n\nExclusion Criteria:\n\n* \"Active\" gastric antral vascular ectasia, as evidenced by bleeding (ie, on esophagogastroduodenoscopy) in the past 6 months or as per Investigator's assessment.\n* History of SSc renal crisis within 1 year prior to Screening; presence of kidney impairment due to conditions other than SSc",{"count":168,"type":22},48,[53],"AID is a phase I multi-cohort study to assess the safety and tolerability of zamtocabtagene autoleucel (zamto-cel) in patients with refractory autoimmune diseases (SLE-Non renal, SLE-LN, SSc\u002FdcSSc) after receiving standard therapy.",[172,90,28,57],"Lupus Nephritis",[174,175,176,149,177,178,179,121,180,181],"Chimeric antigen receptor","CAR T","Zamtocabtagene autoleucel","Immune System Diseases","SLE-Non renal","SLE-LN","dcSSc","Lupus","2026-06-09",{"date":152,"type":33},{"date":185,"type":22},"2026-07",{"date":187,"type":22},"2028-07",{"name":189,"class":74},"Miltenyi Biomedicine GmbH",{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":140,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":200,"phases":4,"briefSummary":201,"conditions":202,"keywords":204,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":41},"100643010","tl1a-inhibition-in-systemic-sclerosis-related-skin-fibrosis-and-immunological-alterations-a-proof-of-concept-in-vitro-study-fibrostop-100643010","NCT07642297","TL1A Inhibition in Systemic Sclerosis-Related Skin Fibrosis and Immunological Alterations: A Proof-of-Concept In Vitro Study (FIBROSTOP)","The Potential Pharmacological Role of the TNF-Like Ligand 1A (TL1A) Inhibition in Modulating Systemic Sclerosis (SSc)-Related Skin Fibrosis and Immunological Alterations: A Proof-of-Concept, In Vitro, Study","FIBROSTOP","Inclusion Criteria:\n\nFor both SSc and healthy control populations:\n\n* Signed written informed consent\n* Age ≥18 years at the time of consent\n\nFor SSc population only:\n\n* Diagnosis of SSc according to ACR\u002FEULAR 2013 classification criteria\n* Diffuse cutaneous SSc subtype (LeRoy et al., 1988)\n* Disease onset (defined as the first non-Raynaud symptom) within 5 years prior to recruitment\n* No new initiation of immunosuppressive therapy (including methotrexate, mycophenolate mofetil, cyclophosphamide, rituximab, tocilizumab, or prednisone \\>20 mg\u002Fday) within the 2 months preceding recruitment\n* Ongoing immunosuppressive therapy must be at a stable dose for at least 1 month prior to enrollment\n\nExclusion Criteria:\n\n* Coexisting active or treated skin diseases (e.g., atopic dermatitis), except for SSc\n* Diagnosis of other systemic autoimmune rheumatic diseases, including overlap syndromes (e.g., SSc + dermatomyositis)\n* History or current signs\u002Fsymptoms of severe or uncontrolled non-rheumatic diseases\n* Active malignancy or history of malignancy within the previous 5 years (except adequately treated non-melanoma skin cancer or in situ cervical carcinoma)\n* Chronic or recurrent infections, including viral hepatitis B\u002FC, HIV, or untreated tuberculosis\n* Severe active infection or major surgery within 8 weeks before enrollment\n* Non-serious skin infections within 8 weeks before enrollment\n* Limited cutaneous SSc or SSc sine scleroderma\n* SSc patients unable to undergo therapeutic stabilization due to severe organ complications\n* Pregnancy or lactation\n* Inability to provide informed consent",{"count":199,"type":22},20,"OBSERVATIONAL","Systemic Sclerosis (SSc) is a rare autoimmune connective tissue disease characterized by microvascular injury, immune activation, and progressive fibrosis of the skin and internal organs. Diffuse cutaneous SSc (dcSSc), particularly in its early phase, is associated with aggressive fibrotic evolution and high morbidity. Despite advances in immunomodulatory therapy, no treatment has proven capable of consistently halting or reversing fibrosis, highlighting the need for new mechanistic targets.\n\nTL1A (TNF-like ligand 1A) is a cytokine of the TNF superfamily expressed by endothelial and immune cells, which interacts with death receptor 3 (DR3) to regulate immune activation, endothelial dysfunction, and tissue remodeling. Elevated TL1A levels have been observed in SSc patients and correlate with disease activity. TL1A has also been shown to promote lung fibrosis in preclinical models.\n\nThe FIBROSTOP study is a proof-of-concept, in vitro, interventional study on biological samples aimed at elucidating the immunological and fibrotic mechanisms regulated by TL1A, and at assessing whether TL1A inhibition can reverse pathogenic processes in SSc.\n\nTen (n=10) patients with early diffuse cutaneous SSc and ten (n=10) age- and sex-matched healthy controls will be enrolled at a single center (Fondazione Policlinico Universitario Campus Bio-Medico, Rome). Each participant will undergo a single visit (T0) involving peripheral blood sampling and skin biopsy. No follow-up visits are planned.\n\nThe study pursues three co-primary objectives: (1) evaluating the role of TL1A and its inhibition in modulating T lymphocyte activity; (2) assessing the effects of TL1A and its inhibition on endothelial cell activation and function; (3) investigating the impact of TL1A and its inhibition on fibrotic remodeling in ex vivo SSc skin cultures using single-cell RNA sequencing.\n\nThe findings may inform future targeted antifibrotic interventions in SSc and other fibrotic diseases.",[28,57,203],"Skin Fibrosis",[205,206,207,208,118,209,210,211],"TL1A","TNF-like ligand 1A","DR3","Fibrosis","T lymphocytes","Endothelial cells","skin biopsy","2026-06-04",{"date":152,"type":33},{"date":215,"type":22},"2026-09-01",{"date":217,"type":22},"2028-09-01",{"name":219,"class":40},"Fondazione Policlinico Universitario Campus Bio-Medico",{"id":221,"slug":222,"hasResults":12,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":23,"phases":229,"briefSummary":230,"conditions":231,"keywords":239,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":262},"100592260","phase-2-allonk-an-allogeneic-non-genetically-modified-cord-blood-derived-nk-cell-therapy-in-combination-with-rituximab-studied-in-relapsing-forms-of-b-cell-dependent-rheumatologic-diseases-100592260","NCT06991114","AlloNK®, an Allogeneic Non-genetically Modified, Cord Blood-derived NK Cell Therapy, in Combination With Rituximab, Studied in Relapsing Forms of B-cell Dependent Rheumatologic Diseases.","An Open-label Phase 2a Study to Evaluate the Safety and Efficacy of AlloNK®, an Allogeneic Cord Blood-derived NK Cell Therapy, in Combination With Rituximab in Relapsing Forms of B-cell Dependent Rheumatologic Diseases","For Subjects with Refractory Rheumatoid Arthritis (RA):\n\n* Documented diagnosis of RA, meeting the 2010 ACR\u002FEULAR classification criteria.\n* Rheumatoid Factor (RF) or Anti Citrullinated Protein Antibody (ACPA) positive.\n* High-sensitivity C-reactive protein (hs-CRP) \\> 3 mg\u002FL or Erythrocyte Sedimentation Rate (ESR) \\> 28 mm\u002Fhr.\n* Have had prior treatment for a period of at least 12 weeks with a biologic disease modifying anti-rheumatic drug and were deemed refractory by the treating physician.\n* Minimum of six swollen joint counts (SJC) and six tender joint counts (TJC) according to joint assessment.\n\nFor subjects with Sjögren's Disease (SjD)\n\n* Prior diagnosis of Primary SjD as per 2016 ACR\u002FEULAR criteria with confirmatory diagnosis in the 24 weeks preceding screening.\n* Total Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) \\> 6.\n* Salivary Flow Rate \\> 0.1 mL\u002Fmin on stimulation.\n\nFor subjects with Idiopathic Inflammatory Myopathies (IIMs)\n\n* Presence of a positive autoantibody (ANA \\>1:80 or RNP or SSA\u002FSSB or other myositis specific autoantibodies.\n* Refractory IIM as defined by inadequate response\u002Fintolerance to at least 3 months of glucocorticoids and\u002For at least one other immunosuppressive.\n* Muscle biopsy or muscle MRI to confirm IIM diagnosis, where applicable, within 12 months prior to enrollment.\n\nFor Subjects with Systemic Sclerosis (SSc)\n\n* Diagnosis of SSc in accordance with the ACR\u002FEULAR 2013 classification.\n* Modified Rodnan skin score (mRSS) \\> 10.\n* Initial confirmatory diagnosis within 8 years of screening.\n* Refractory SSc as defined by inadequate response\u002Fintolerance to at least 3 months of glucocorticoids and\u002For at least one other immunosuppressive.",{"count":228,"type":22},90,[54],"A Basket Trial of Refractory Rheumatoid Arthritis (RA), Sjögren's Disease (SjD), Idiopathic Inflammatory Myopathies (IIMs) and Systemic Sclerosis (SSc) subjects to evaluate the safety and efficacy of AlloNK, a non-genetically modified allogeneic NK cell, in combination with rituximab.",[232,233,28,234,235,236,118,237,238],"Refractory Rheumatoid Arthritis (RA)","Idiopathic Inflammatory Myopathies (IIMs)","Rheumatoid Arthritis (RA","IIM","Myositis","Sjogren Syndrome","Sjogrens Disease",[240,241,91,147,242,243,244,245,246,247,248,249,250,251,252],"Refractory Rheumatoid Arthritis","AlloNK","Sjögren's Disease","Refractory RA","Cell Therapy","Allogeneic NK Cells","Allogeneic Cell Therapy","non-genetically modified","rituximab","cord blood cells","ADCC enhancement","outpatient","community","2026-05-20",{"date":255,"type":33},"2026-05-22",{"date":257,"type":33},"2025-07-09",{"date":259,"type":22},"2029-01",{"name":261,"class":74},"Artiva Biotherapeutics, Inc.",52,{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":18,"minAge":269,"maxAge":270,"enrollmentInfo":271,"targetDuration":4,"studyType":23,"phases":273,"briefSummary":274,"conditions":275,"keywords":279,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":301},"100539833","phase-1-a-phase-1-study-of-ft819-in-b-cell-mediated-autoimmune-disease-100539833","NCT06308978","A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease","Key Inclusion Criteria:\n\n* Age: 12 to 70 years old.\n* Diagnosis: Must have active B-cell mediated autoimmune disease (SLE, AAV, IIM, or SSc) confirmed by standard criteria.\n* Disease Severity: Moderate to severe, requiring at least two prior treatments that were ineffective.\n* Health Status: Adequate organ function to tolerate treatment.\n* Consent: Able to provide informed consent or assent\u002Fobtain parental consent and comply with study procedures.\n\nKey Exclusion Criteria:\n\n* Pregnancy\u002FBreastfeeding: Women must not be pregnant or nursing.\n* Severe Organ Dysfunction: Significant heart, lung, liver, or kidney impairment.\n* Active Infections: No recent or ongoing serious infections.\n* Recent Cancer or Prior Cell Therapy: No active\u002Frecent malignancies, prior CAR T-cell therapy, or organ transplant.\n* Allergies: No known allergies to study treatments.\n* Weight Restriction: Must weigh at least 50 kg (110 lbs).","12 Years","70 Years",{"count":272,"type":22},244,[53],"This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe active systemic lupus erythematosus (SLE) with or without nephritis, antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT819.",[276,277,28,278,172],"Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV)","Idiopathic Inflammatory Myositis (IIM)","Systemic Lupus Erythematosus (SLE)",[280,281,282,283,284,285,286,287,288,289,290,291,292,293,172],"FT819","Fate Therapeutics","Idiopathic inflammatory myositis (IIM)","Systemic lupus erythematosus (SLE)","Systemic sclerosis (SSc)","Antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV)","Allogeneic CAR-T","CD19-Targeted Therapy","Cell Therapy for Autoimmune Diseases","B-Cell Depletion in Autoimmune Disease","Phase 1 Clinical Trial","Allogeneic CAR cells","Autoimmune Diseases","A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Diseases","2026-05-19",{"date":255,"type":33},{"date":297,"type":33},"2024-03-28",{"date":299,"type":22},"2042-09-30",{"name":281,"class":74},21,{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":18,"minAge":309,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":23,"phases":311,"briefSummary":312,"conditions":313,"keywords":318,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":41},"100639684","early-phase-1-cd19bcma-ucar-t-for-b-cell-related-autoimmune-disease-100639684","NCT07586267","CD19\u002FBCMA UCAR-T for B Cell-Related Autoimmune Disease","An Exploratory Clinical Study Evaluate the Safety and Efficacy of Universal Universal Allogeneic CAR-T Cells Targeting CD19 and BCMA in the Treatment of B Cell-Related Autoimmune Disease","Inclusion Criteria:\n\n* Common Inclusion Criteria:\n* 1.Major organ function must meet the following criteria (exceptions allowed for abnormalities related to autoimmune disease activity):\n\n  1. Bone Marrow Function: a. Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL; b. Hemoglobin ≥ 60 g\u002FL; c. Platelet count ≥ 30 × 10⁹\u002FL.\n  2. Hepatic Function: ALT ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); AST ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); Total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN allowed for Gilbert syndrome).\n  3. Renal Function: eGFR ≥ 30 mL\u002Fmin\u002F1.73 m².(Participants with eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² and\u002For those receiving renal replacement therapy may be considered eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant or guardian provides fully informed consent.)\n  4. Cardiac Function: Echocardiography shows no significant structural abnormalities and left ventricular ejection fraction (LVEF) ≥ 55%.\n  5. Pulmonary Function: No severe pulmonary disease, and SpO₂ ≥ 92%.\n* 2.Women of childbearing potential must use medically acceptable contraception or practice abstinence during the study treatment period and for at least 12 months after the end of study treatment.\n* 3.Informed consent: The participant (and guardian if the participant is a minor) must provide written informed consent, indicating understanding of the study purpose and procedures and willingness to participate.\n* Disease-Specific Inclusion Criteria\n* SLE:\n* 1.Age ≥ 5 years.\n* 2.Meets the 2012 SLICC or 2019 EULAR\u002FACR classification criteria for SLE.\n* 3.Must meet at least one of the following adequate treatment conditions:\n\n  1. Active disease persists despite adequate treatment with glucocorticoids (≥1 mg\u002Fkg\u002Fday prednisone or equivalent dose of other corticosteroids) in combination with at least two immunosuppressants or biologic agents for at least 3 months, or affected organ function has failed to improve; or inability to taper glucocorticoid dosage to ≤5 mg\u002Fday after 6 months of conventional treatment;\n  2. Patients who have developed intolerable drug toxicity during conventional therapy, or have contraindications precluding standard treatment, or have experienced multiple treatment failures-may be considered for enrollment following full informed consent by the investigator and the patient or legal guardian;\n  3. SLEDAI-2K Criteria: SLEDAI-2K score ≥8; or SLEDAI-2K score ≥6 combined with at least one BILAG-2004 Category A or two Category B organ system involvements (or both)；Patients with severe refractory SLE-ITP, characterized by a platelet count of \\\u003C30×10⁹\u002FL or \\\u003C50×10⁹\u002FL accompanied by bleeding tendency, regardless of the SLEDAI-2K score.\n* 4.No occurrence of macrophage activation syndrome within 1 month prior to screening.\n* 5.Occurrence of CNS lupus symptoms requiring intervention within 60 days prior to screening, including seizures, psychosis, cerebrovascular events, etc.\n* MDR-SRNS\n* 1.Age ≥3 years old, gender unlimited.\n* 2.Diagnosed with SRNS according to the 2021 Kidney Disease: Improving Global Outcomes #KDIGO# Guidelines;\n* 3\\. Must meet at least one of the following adequate treatment conditions:\n\n  1. have not achieved a complete response after 12 months of treatment with two standard doses of hormone replacement drugs with different mechanisms of action or relapse of disease activity after remission(at least one of the two drugs is a calcineurin inhibitor such as cyclosporine or tacrolimus, Other replacement drugs include Mycophenolate Mofetil, cyclophosphamide, Telitacicept or rituximab).\n  2. if no remission has been achieved after 3 to 6 months of adequate treatment with one calcineurin- inhibitor. The researcher judges that the benefits outweigh the risks and the patient or guardian has fully informed consent, the patient can be considered for inclusion.\n  3. Patients unable to tolerate conventional therapy may be eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant (or guardian if minor) provides fully informed consent.\n  4. Patients with other diseases, such as systemic lupus erythematosus, requiring long-term systemic treatment with glucocorticoids or immunosuppressants, may be considered for inclusion after the investigator determines that the benefits outweigh the risks, and the patient or guardian has fully informed consent.\n* 4.Renal biopsy was performed and the pathological type was determined to be minimal lesion nephropathy(MCD) or focal segmental glomerulosclerosis (FSGS);\n* IgA nephropathy\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. IgA nephropathy pathologically confirmed by renal biopsy;\n* 3\\. Angiotensin-Converting Enzyme Inhibitors (ACEI) or angiotensin receptor blocker (ARB) treated for at least 3 months and meet at least one of the following requirements:\n\n  1. Combination or sequential treatment with steroids and at least one immunosuppressant or biologic for ≥ 3 months; and 24-hour urine protein quantification ≥500mg or UPCR≥0.5mg\u002Fmg;\n  2. \\>50% decline in eGFR within 3 months;\n  3. Patients who are unable to tolerate conventional treatment and for whom the investigator determines the benefits outweigh the risks and who have obtained fully informed consent from the patient or guardian may be considered for inclusion;\n* 4\\. Exclude subjects with other secondary causes; exclude patients with uncontrolled blood pressure.\n* Systemic Sclerosis:\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. Scleroderma fulfilling the 2013 ACR classification criteria\n* 3\\. Positive scleroderma-related antibodies.\n* 4\\. Modified Rodnan Skin Score (mRSS) ≥ 15 (total score 51).\n* 5\\. Must meet at least one of the following adequate treatment conditions:\n\n  1. Treated with glucocorticoids (≥0.5 mg\u002Fkg\u002Fday) plus at least one immunomodulatory agent (including antimalarials, cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or biologics such as rituximab, belimumab, thalidomide) for more than 3 months without significant improvement.\n  2. Meets criteria for rapidly progressive disease and is unresponsive to standard therapy; participant may be enrolled if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n  3. Patients unable to tolerate conventional therapy may be eligible if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n* 6\\. Presence of severe pulmonary arterial hypertension (PAH), defined as a mean pulmonary arterial pressure \\>45 mmHg, or other severe involvement of major organs will be exclude.\n* Refractory\u002FRelapsed ANCA-Associated Vasculitis:\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. Meets the diagnostic criteria for ANCA-associated vasculitis according to the 2007 European Medicines Agency (EMA) algorithm or the 2022 ACR\u002FEULAR classification criteria, including microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA).\n* 3\\. Refractory AAV is defined as: a reduction in the Birmingham Vasculitis Activity Score (BVAS) of less than 50%, a persistent score of ≥ 3, or the occurrence of new organ involvement following ≥3 months of standard induction therapy (including glucocorticoids in combination with Rituximab \\[RTX\\] or Cyclophosphamide \\[CYC\\]) ;or a worsening of the disease during maintenance therapy or after treatment discontinuation following the achievement of remission (BVAS = 0), which necessitates the re-initiation of induction therapy;\n* 4\\. Or meets the criteria for severe vasculitis, with inadequate response to standard-of-care therapy, and may be considered for enrollment if the investigator determines that the potential benefits outweigh the risks and the patient or legal guardian provides fully informed consent.\n* 5\\. Evidence of active vasculitis meeting the following criteria: For participants \\\u003C18 years of age: Pediatric Vasculitis Activity Score (PVAS) ≥10 (total score 63); For participants ≥18 years of age: Birmingham Vasculitis Activity Score (BVAS) ≥10 (total score 63); indicating active vasculitis.\n* 6\\. Exclusion Criterion: Presence of alveolar hemorrhage requiring ventilatory support for more than one week.\n\nExclusion Criteria:\n\n* 1\\. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, tocilizumab), or subjects with a history of severe allergic reactions.\n* 2.Subjects with grade III or IV heart failure (NYHA classification).\n* 3.Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs.\n* 4\\. Uncontrollable infection, or active infection that requires systemic treatment at screening.\n* 5\\. Had active pulmonary tuberculosis at screening.\n* 6\\. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive; Or cytomegalovirus (CMV) DNA test positive.\n* 7\\. History of severe herpes infection prior to screening, such as herpetic encephalitis, ocular herpes, or disseminated herpes; Signs of herpes or varicella-zoster virus infection (especially chickenpox, shingles) within 12 weeks prior to screening.\n* 8\\. Patients had active central nervous system disease.\n* 9\\. Patients with malignant diseases such as tumors before screening.\n* 10\\. Secondary or congenital immunodeficiency.\n* 11\\. History of any cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal disease or other major medical condition that would prevent the administration of QT-019B, except for lupus.\n* 12\\. Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; Acute graft-versus host disease (GVHD) of grade 2 or above was present within 2 weeks prior to screening.\n* 13\\. Received live vaccine within 4 weeks before screening.\n* 14\\. Tested positive in Blood pregnancy test.\n* 15\\. Patients who had participated in other clinical trials and received any intervention within 3 months before enrollment.\n* 16\\. Any abnormal laboratory test results judged by the investigator to be clinically significant and prevent the subject from participating in the study. Laboratory test values that are out of range and not of clinical significance will not be considered as exclusion criteria.\n* 17\\. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.","3 Years",{"count":85,"type":22},[87],"This is an exploratory, open-label, single-arm clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of QT-219CX. QT-219CX is a universal allogeneic chimeric antigen receptor T-cell (CAR-T) product targeting both CD19 and BCMA. The study targets subjects with refractory B-cell-related autoimmune diseases, including systemic lupus erythematosus (SLE), multi-drug resistant nephrotic syndrome (NS), IgA nephropathy (IgAN), systemic sclerosis (SSc), and ANCA-associated vasculitis (AAV) .The research is divided into two phases: a dose-escalation phase and a dose-expansion phase. Dose Escalation: Utilizes a standard \"3+3\" design to evaluate potential recommended dose(RD) and identify dose-limiting toxicities (DLTs) .Treatment Procedure: Eligible subjects will receive a lymphodepleting conditioning regimen followed by a single intravenous infusion of QT-219CX .Primary Objectives: The primary goals are to evaluate the safety profile, including the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and to assess clinical response rates at 90 days post-infusion .Follow-up: Subjects will be monitored for pharmacokinetics (cell expansion), pharmacodynamics (B-cell depletion), and long-term safety for up to two years .",[292,314,315,316,28,317],"Systemic Lupus Erthematosus (SLE)","Multi-Drug Resistant Nephrotic Syndrome","IgA Nephropathy (IgAN)","ANCA Associated Systemic Vasculitis",[319,315,314,316,28,320],"UCART","ANCA associated systemic vasculitis","2026-05-12",{"date":323,"type":33},"2026-05-14",{"date":325,"type":22},"2026-05-08",{"date":327,"type":22},"2030-12-31",{"name":329,"class":40},"The Children's Hospital of Zhejiang University School of Medicine",{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":23,"phases":339,"briefSummary":340,"conditions":341,"keywords":345,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":41},"100567794","phase-2-intralesional-injection-of-sts-in-treatment-of-calcinosis-100567794","NCT06672822","Intralesional Injection of STS in Treatment of Calcinosis","An Open Label Evaluation of Intralesional Injection of Sodium Thiosulfate in the Treatment of Cutaneous or Tendon Calcinosis in Connective Tissue Disease","STSINJ","Inclusion Criteria:\n\n* Clinical diagnosis of systemic sclerosis, mixed connective tissue disease or inflammatory myopathy\n* Must be over 18 years of age\n* Participants must be competent to give informed consent\n* Participants must have radiographic evidence (xray or ultrasound) of calcinosis.\n* Participants must need symptomatic relief\n\nExclusion Criteria:\n\n• Pregnant women will be excluded",{"count":199,"type":22},[54],"The specific objective of this study is to perform a small, open-label study to assess the safety and efficacy of intralesional, subcutaneous injection of STS on calcinosis symptoms and lesion size in systemic sclerosis (SSc), mixed connective tissue disease (MCTD) and dermatomyositis (DM) patients. Injection will be guided by ultrasound, lesion size assessed by ultrasound, and symptom burden by patient-reported outcome measures.",[28,342,343,344],"Dermatomyositis","Mixed Connective Tissue Disease (MCTD)","Calcinosis",[346],"calcinosis","2026-05-03",{"date":349,"type":33},"2026-05-05",{"date":351,"type":33},"2025-03-17",{"date":353,"type":22},"2029-05-01",{"name":355,"class":40},"Robyn T. Domsic, MD, MPH",{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":363,"enrollmentInfo":364,"targetDuration":4,"studyType":23,"phases":366,"briefSummary":367,"conditions":368,"keywords":375,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":41},"100599529","phase-1-phase-1-study-of-hbi0101-car-t-in-refractory-b-cell-autoimmune-diseases-100599529","NCT07085676","Phase 1 Study of HBI0101 CAR-T in Refractory B-Cell Autoimmune Diseases","A Phase 1 Dose Escalation and Safety Study of HBI0101 CART in B-cell Mediated Refractory Autoimmune Diseases","Inclusion Criteria:\n\n1. Age: 18\\~80 years old; for patients aged ≥ 75 years, geriatric assessment and endorsement are required;\n2. Diagnosis of B-cell mediated ARDs listed below:\n\n   SLE patients: individuals diagnosed with SLE according to American College of Rheumatology (ACR) and\u002For Systemic lupus international collaborating clinics (SLICC) classification criteria, who have severe and progressive disease course reflected by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score of 8 or more. Eligible patients must have failed to at least one of the conventional DMARDs (azathioprine, methotrexate, mycophenolate mofetil or cyclophosphamide), one of the calcineurin inhibitors (tacrolimus or cyclosporin) and one of the biologic agents (belimumab, rituximab or aniflorumab), each administered for a minimum of 3 months, or have a contraindication to, or have experienced toxicity from, any therapy within these categories. The failure is defined as:\n   * lack of response per SLEDAI-2k (\\\u003C4 points reduction from baseline) or no improvement in BILAG domains, or\n   * disease flare per SLEDAI-2k (≥4 points increase from baseline) or new BILAG A or ≥2 new BILAG B organ scores, or intolerance or discontinuation due to adverse effects.\n\n   SSc patients: Patients who were diagnosed with diffuse or limited cutaneous SSc according to the College of Rheumatology\u002FEuropean Alliance of Associations for Rheumatology (ACR-EULAR) classification criteria, with severe or rapidly progressive disease Eligible patients must meet any of the following criteria:\n   * Progression of skin thickening ≥ 12 over the past 6 months or Modified Rodnan skin score (mRSS) ≥15\n   * Any Medsger Disease Severity Score grade 3-4 in one major organ or grade ≥2 in two organs\n   * Progressive interstitial lung disease evidenced by HRCT or FVC \\\u003C80% or DLCO \\\u003C80%, or evidence of pulmonary function decline, defined as an absolute FVC decline of ≥ 10% , or FVC decline of 5% -9% combined with DLCO 15%.\n   * Other internal organ involvement.\n\n   Eligible patients must have failed to at least two state-of-the-art immunosuppressive therapies including MTX, MMF, cyclophosphamide, azathioprine, nintedanib, tocilizumab or rituximab; each therapy must have been administered for a minimum of 3 months, unless discontinued due to a contraindication or toxicity. The failure is defined as:\n   * lack of response in skin per mRSS (≤20% relative and ≤5 point absolute reduction from baseline) or no clinically meaningful improvement in FVC, DLCO, or other organ involved assessed by Medsger DSS, or\n   * disease flare in skin per mRSS (increase in mRSS ≥20% and ≥5 points from baseline) or decline in FVC ≥10% predicted or in DLCO ≥15% predicted from baseline, other major SSc complication, or\n   * intolerance or discontinuation due to adverse effects\n\n   IIM, including dermatomyositis, anti-synthetase syndrome, immune mediated necrotizing myopathy, and polymyositis: patients must be diagnosed with IIM according to the 2017 ACR\u002FEULAR Classification Criteria for idiopathic inflammatory myopathies.\n\n   Eligible patients must have active disease, defined by at least one of the following:\n   * CPK ≥4xULN\n   * Loss of muscle strength in the weakest muscle group for less than 80% per MMT8\n   * Evidence on MRI of active myositis within last 6 months\n   * Evidence on EMG of active myositis within last 6 months\n   * Muscle biopsy evidence of active myositis within last 6 months\n\n   Only patients with refractory disease will be recruited, defined as previous failure to (1) at least two of five non-glucocorticoids immunosuppressive therapies and (2) either rituximab or IVIG, each administered for a minimum of 3 months, or have a contraindication to, or have experienced toxicity from, any therapy within these categories. The five non-glucocorticoids therapies considered are azathioprine, MTX, MMF, IVIG, and rituximab The failure is defined as:\n   * lack of response in muscle strength per MMT-8 or CPK (\\\u003C20% relative improvement) or per MRI or\n   * disease flare in muscle strength per MMT-8 (≥30% decline) or CPK (≥30% rise) or objective worsening of other organ involvement per Myositis Disease Activity Assessment Tool or\n   * intolerance or discontinuation due to adverse effects\n\n   RA patients: Seropositive RA patients (positive for anti-cyclic citrullinated peptide and rheumatoid factor), diagnosed according to the 2010 ACR\u002FEULAR classification criteria.\n\n   Eligible patients must exhibit high disease activity (DAS28CRP ≥5.1), and be resistant to at least four conventional synthetic and biologic disease-modifying antirheumatic drugs (DMARD) groups.\n\n   Each patient must have previously received at least one medication from each of the mentioned groups, including\n   * JAK-STAT inhibitors\n   * Anti-TNF agents\n   * Anti-IL6 drugs\n   * Anti-CTLA4-Ig treatments, each administered for a minimum of 3 months, or have a contraindication to, or have experienced toxicity from, any therapy within these categories\n\n   Drug resistance is defined as:\n   * Inadequate clinical response measured by composite score DAS28CRP (\\> 3.6) or failure to reach ACR20 or\n   * Disease progression measured by DAS28CRP (≥20% increase) or radiographic progression or\n   * Intolerance or discontinuation due to adverse effects\n\n   NMOSD: Patients must be diagnosis of AQP4-IgG-positive NMOSD based on the 2015 International Panel for NMOSD Diagnosis (IPND) criteria (Wingerchuk et al., 2015).\n\n   Eligible patients must have experienced at least two relapses in the past 24 months, with at least one occurring in the preceding 12 months before screening Each patients must have previously received with inadequate disease control (one or more clinical attacks, with new MRI activity, despite adequate treatment dosing) at least one immunosuppressant for at least 6 months (azathioprine or mycophenolate mofetil) and\u002For Rituximab for at least 3 months and\u002For a targeted therapy (eculizumab, inebilizumab, or satralizumab) or must have a contraindication to such treatment.\n\n   MS patients: must have confirmed history of diagnosis of primary progressive or secondary progressive MS .\n\n   Eligible patients must have: Expanded Disability Status Scale (EDSS) score between 3.0 and 8.5 and evidence of disease activity, defined by either clinical progression and\u002For radiological finding on MRI, such as new, enhancing or enlarging lesions in the last 12 months.\n\n   Eligible patient must have previously received at least one high efficacy drug and have been offered standard treatments and have experienced disease progression or lack of efficacy despite at least six months of treatment. These will include clinical activity (new relapse\\[s\\]), radiological activity (new or enlarging T2 lesions and\u002For gadolinium-enhancing lesions on MRI), or confirmed disability progression (an increase in least 1 point on the EDSS sustained for ≥6 months).\n\n   Eligible patient must have history of treatment with anti-CD20 mAb with continuing evidence of worsening physical disability over a period of ≥6 months, with documented clinical disability progression within the year prior to inclusion, irrespective to concurrent MRI activity.\n\n   MG patients must meet all the following criteria:\n\n   \\- Confirmed diagnosis of generalized MG, supported by positive autoantibodies (anti-AChR, anti-MuSK).\n\n   Disease Severity:\n   * Myasthenia Gravis Activities of Daily Living (MG-ADL) score of ≥6, with ocular symptoms constituting less than 50% of the total score.\n   * Myasthenia Gravis Foundation of America (MGFA) clinical classification of II to IV.\n\n   Eligible patients must have Refractory Status and meet at least one of the following criteria:\n   * No improvement or worsening myasthenic symptoms, with failure to achieve minimal manifestation status or meaningful improvement in MGFA class or MG-ADL score, or recurrent myasthenic exacerbations despite adequate immunosuppressive or immunomodulatory therapy for at least 6 months for all therapies and 3 months for B cell depletion therapy\n   * Improvement in Post-Intervention Status (PIS), but with an MG-ADL score ≥6 persisting for at least 4 months.\n   * Remission or improvement in PIS, but with ≥1 episode of disease exacerbation (MG-ADL ≥6) per year during tapering of immunotherapy medications.\n   * After experiencing a myasthenic crisis, patients who undergo multiple immunotherapies (e.g., intravenous immunoglobulin, plasma exchange, high-dose intravenous methylprednisolone), thymectomy, and active infection control but still cannot be weaned off the ventilator due to MG-induced respiratory muscle weakness for more than 14 days.\n\n   Each patient must receive stable doses of medication prior to enrollment.\n\n   Refractory APLA patients: must have confirmed history of APLA, based on Sydney 2006 or ACR\u002FEULAR 2023 criteria\n\n   \\- Eligible patients must have medium to high-titer antiphospholipid antibodies, documented repeatedly (≥2 tests spanning 12 weeks) Eligible patients must have refractory disease: persistent or recurrent arterial thrombosis, venous thrombosis or diffuse alveolar hemorrhage despite conventional therapy with stable treatment with vitamin K antagonist anticoagulation (maintained at therapeutic stable dose keeping INR consistently within target range) and immunosuppression treatment including glucocorticoid, rituximab and Plaquenil\n3. AST\u002FALT below 5 times the upper limit of normal, blood bilirubin below 3 times the upper limit of normal ;\n4. Cardiopulmonary function is basically normal, echocardiography indicates that the ejection fraction is \\>45%, normal to mild pulmonary hypertension, and the oxygen saturation is above 93% in the resting state without oxygen;\n5. No obvious active infection;\n6. There are no contraindications for blood collection;\n7. Women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months, must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study;\n8. Voluntary participation and informed consent signed by the patient or his\u002Fher legal\u002Fauthorized representative.\n9. Ability and willingness to adhere to the study visit schedule and all protocol requirements\n\nExclusion Criteria\n\n1. CNS disease- History of CNS or spinal cord tumor, metabolic or infectious cause of myelopathy, genetically inherited progressive CNS disorder, sarcoidosis, non-autoimmune progressive neurologic condition or PML\n2. Abnormal liver function: aspartate transaminase (AST) or alanine transaminase (ALT) or glutamyl transpeptidase (GGT) or alkaline phosphatase (ALP) detection value is greater than 5 times the upper limit of normal (ULN); or total bilirubin test value greater than 3 times the upper limit of normal (ULN); Exceptional: liver function disturbance due to myositis.\n3. Cardiovascular disease: Unstable angina or myocardial infarction or coronary artery bypass graft (CABG) within 6 months prior to leukapheresis\u002F moderate- severe pulmonary hypertension\u002F severe arrhythmia (ventricular tachycardia, ventricular fibrillation, high grade ventricular block) in the past 6 months; New York heart function class (NYHA) class III- Level IV or LVEF\\\u003C45%.\n4. Lung disease: patients with chronic lung disease with any of the following: \\* Oxygen saturation (SpO2) \\\u003C 90% on room air \\* FVC≤45% of predicted or DLCO≤40% of predicted at screening. \\* Evidence of pulmonary hypertension as defined as estimated RVSP\\> 50 mmHg.\n5. Muscle disease: evidence of any of the following: \\* Severe proximal muscle atrophy of upper or lower extremity on MRI or clinical examination. \\*Finding of muscular inflammation or myopathy other than the indication, such as inclusion body myositis (IBM), or cancer-associated myositis (myositis diagnosed within 2 years of cancer).\n6. Other uncontrolled diseases: acute diseases (such as acute pneumonia or other infection, pulmonary embolism, diabetic ketoacidosis, acute pancreatitis, etc.) that are clinically unstable or have not been effectively controlled and are not related to indicated autoimmune diseases which in the judgment of the investigator may confound study results or place subjects at undue risk.\n7. Biologics therapy: Received rituximab within 4 months of expected CAR T treatment: No plasma exchange or immunoglobulin treatment within 4 weeks prior to screening. MS patients: No high dose corticosteroid treatment in the 30 days prior to enrollment; see also section 9.1 for the list of restrictions.\n8. Participated in any clinical study within 3 months prior to enrollment, or participate in other clinical investigations during the study period.\n9. Previous or concurrent malignancy with the following exceptions: Adequately treated basal cell or squamous cell carcinoma, in situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to screening. A primary malignancy which has been completely resected, or treated, and is in complete remission for at least 5 years prior to screening.\n10. Transplantation: History of vital organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell\u002For bone marrow transplantation.\n11. Disease-specific criteria: MS\u002FNMO patients: No disease relapse in the 30 days prior to enrollment\n12. Known HIV positive status.\n13. Active hepatitis B or C infection.\n14. Active CMV infection\n15. Pregnant or lactating women.\n16. Inability to understand or follow the research protocol subject requirements.\n17. Have any other clinically significant disease history or current disease that, in the judgment of the research physician, may pose a risk to the safety of the subjects, or interfere with the completion of the research procedure and the evaluation of safety and efficacy","80 Years",{"count":365,"type":22},120,[53],"A Phase 1 study of HBI0101 BCMA-CART in B-Cell Mediated Autoimmune Rheumatic Diseases. The goal of the study is evaluation of safety and identification of the maximum HBI0101 CART dose that may be administered safely to patients with B-cell mediated autoimmune disease.",[28,369,58,278,370,371,372,373,374],"Idiopathic Inflammatory Myopathy (IIM)","Multiple Sclerosis (MS) Primary Progressive","Multiple Sclerosis (MS) Secondary Progressive","Neuromyelitis Optica Spectrum Disorder (NMOSD)","Myasthenia Gravis (MG)","Antiphospholipid Antibody Syndrome",[376,278,377,378,379,380,381,382,372,373,383],"B-cell mediated autoimmune rheumatic diseases","Systemic sclerosis (SSC)","Idiopathic inflammatory myopathy (IIM)","Rheumatoid arthritis (RA)","B-cell maturation antigen (BCMA)","Autologous CAR-T","Multiple sclerosis (MS) Primary and Secondary progressive","refractory antiphospholipid antibody syndrome","2026-04-29",{"date":386,"type":33},"2026-05-06",{"date":388,"type":33},"2024-09-01",{"date":390,"type":22},"2030-11-01",{"name":392,"class":40},"Polina Stepensky",{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":401,"targetDuration":4,"studyType":23,"phases":403,"briefSummary":404,"conditions":405,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":415},"100566436","phase-2-a-study-to-assess-the-efficacy-and-safety-of-efgartigimod-ph20-sc-in-adults-with-systemic-sclerosis-100566436","NCT06655155","A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis","A Randomized, Double-Blinded, Placebo-Controlled, Phase 2, Parallel-Group Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Adult Participants With Systemic Sclerosis","eSScape","Inclusion Criteria:\n\n* Is aged ≥18 years and the local legal age of consent for clinical studies\n* Has diffuse or limited SSc diagnosis and fulfills the 2013 ACR\u002FEULAR classification criteria\n* Has a positive antinuclear antibodies (ANA) test result at the central laboratory with titer of at least 1:160\n* Has a Health Assessment Questionnaire-Disability Index (HAQ-DI) score of at least 0.5 OR a Patient Global Assessment (PGA) score of at least 3\n* Has a modified Rodnan Skin Score (mRSS) score between 15 and 35\n* The participant is anti-RNA polymerase III autoantibody negative at central laboratory and had the first non-Raynaud's phenomenon manifestation less than 5 years before screening or the participant is anti-RNA polymerase III autoantibody positive at central laboratory and had the first non-Raynaud's phenomenon manifestation less than 2 years before screening\n* Has uninvolved or mildly thickened skin area in at least 1 injection site\n\nExclusion Criteria:\n\n* Isolated anticentromere antibodies (ACA) seropositivity at the central laboratory\n* Significant Pulmonary Arterial Hypertension\n* Severe digital vasculopathy within the past 3 months\n* Skin thickening due to scleroderma mimics or localized scleroderma\n* Scleroderma renal crisis within the past 6 months of participating to the study\n* Another rheumatic autoimmune disease, except for secondary Sjögren's syndrome or fibromyalgia",{"count":402,"type":22},81,[54],"The main purpose of this study is to evaluate the effect and safety of efgartigimod PH20 SC compared to placebo in adults with systemic sclerosis. The study consists of a screening period, a treatment period of up to 48 weeks and a safety follow-up period. After the screening period, eligible participants will be randomized in a 2:1 ratio to receive either efgartigimod PH20 SC or placebo. The total study duration can be up to approximately 15 months.\n\nMore information can be found on: https:\u002F\u002Fclinicaltrials.argenx.com\u002Fesscape",[28],"2026-04-22",{"date":408,"type":33},"2026-04-23",{"date":410,"type":33},"2024-11-11",{"date":412,"type":22},"2027-09",{"name":414,"class":74},"argenx",74,{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":422,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":83,"enrollmentInfo":424,"targetDuration":4,"studyType":23,"phases":425,"briefSummary":426,"conditions":427,"keywords":428,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":435,"leadSponsor":437,"locationsCount":4},"100634149","phase-1-umbilical-cord-mesenchymal-stem-cells-uc-msc-in-the-treatment-of-systemic-sclerosis-100634149","NCT07535931","Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in the Treatment of Systemic Sclerosis","A Phase I\u002FⅡ Clinical Trial for HS_SW01 Cells Injection in the Treatment of Systemic Sclerosis","HS_SW01","Inclusion Criteria:\n\n1. Voluntarily signed informed consent form.\n2. Age 18 to 65 years, inclusive, male or female.\n3. Diagnosis of systemic sclerosis (SSc) according to the 2013 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria.\n4. Diagnosis of diffuse cutaneous systemic sclerosis at screening, with disease duration ≤5 years (disease onset defined as the time of initial SSc diagnosis).\n5. Prior treatment with at least two of the following: corticosteroids, immunosuppressants, or biologic agents, and a modified Rodnan skin score (mRSS) between 10 and 30, inclusive.\n6. Female subjects must meet one of the following:\n\n   1. Of non-childbearing potential, defined as at least one year postmenopausal or surgically sterilized; or\n   2. Of childbearing potential and agree to use effective contraception from the signing of informed consent through at least 6 months after the last dose of study drug, with a negative serum pregnancy test at screening.\n\nExclusion Criteria:\n\n1. At screening, the patient's percent predicted forced vital capacity (FVC) is \\\u003C50%.\n2. Previously diagnosed with moderate or severe pulmonary arterial hypertension, or systolic pulmonary artery pressure \\>45 mmHg measured by echocardiography at screening.\n3. Presence of newly onset or worsening of pre-existing clinical symptoms requiring hospitalization as judged by the investigator prior to screening, including the following:\n\n   ① Myocardial infarction, stroke, scleroderma renal crisis, severe intestinal disease, or uncontrolled severe hypertension (≥160\u002F100 mmHg) with newly onset or worsening of pre-existing clinical symptoms within 6 months.\n\n   ② Unstable ischemic heart disease, uncontrolled cardiac arrhythmia, heart failure (New York Heart Association Class III\u002FIV), left ventricular ejection fraction \\\u003C50% by echocardiography, renal insufficiency, or renovascular hypertension within 3 months.\n4. Presence of other autoimmune connective tissue diseases other than systemic sclerosis at screening, except for patients with secondary Sjögren's syndrome who are permitted to participate in this trial.\n5. Any of the following laboratory abnormalities at screening:\n\n   ① Hematologic abnormalities: hemoglobin \\\u003C90 g\u002FL; white blood cell count \\\u003C3.0×10\\^9 \u002FL; absolute neutrophil count \\\u003C1.5×10\\^9 \u002FL; platelet count \\\u003C90×10\\^9 \u002FL.\n\n   ② Hepatic abnormalities: ALT or AST \\>3× upper limit of normal (ULN); total bilirubin \\>3× ULN.\n\n   ③ Renal abnormalities: estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m², or any uncontrolled, clinically significant laboratory abnormality that may interfere with data interpretation or subject participation.\n6. Positive test for human immunodeficiency virus antibody (anti-HIV-Ab), active syphilis, active hepatitis C (positive for HCV antibody with detectable HCV-RNA), or positive for HBsAg with detectable HBV-DNA at screening; or history of severe active or recurrent bacterial, viral, fungal, parasitic, or other infections at screening.\n7. Receipt of inactivated or live-attenuated vaccine within 2 months prior to enrollment.\n8. Any of the following within 3 months prior to enrollment:\n\n   ① Major trauma or major surgery (including joint surgery), or need for major surgery during the study period that, in the investigator's opinion, would pose an unacceptable risk to the subject.\n\n   ② Treatment with plasmapheresis or extracorporeal photopheresis.\n\n   ③ Participation in any other interventional clinical trial.\n9. Prior treatment with stem cell-based therapy less than 3 months before enrollment.\n10. History of any malignancy within 5 years prior to enrollment, except for adequately treated or resected basal cell carcinoma or squamous cell carcinoma of the skin, or cervical carcinoma in situ.\n11. Intolerance or contraindication to the study treatment, including any of the following:\n\n    ① Allergy to albumin contained in the excipients of the investigational product.\n\n    ② Absence of peripheral venous access.\n12. Heavy smoking, heavy drinking, or drug abuse within 12 months prior to screening or during the screening period:\n\n    ① Heavy smoking defined as an average of ≥5 cigarettes per day within 3 months prior to screening.\n\n    ② Heavy drinking defined as consumption of more than 14 units of alcohol per week within 3 months prior to screening (1 unit = 350 mL of beer, 45 mL of liquor, or 150 mL of wine).\n\n    ③ Drug abuse defined as a history of drug addiction or drug abuse.\n13. Plan to father or bear children within at least 6 months following the last dose, or unwilling to use effective contraception with their partner, or plan to donate sperm or eggs.\n14. Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study.",{"count":301,"type":22},[53,54],"The goal of this clinical trial is to evaluate the safety and tolerability of human umbilical cord mesenchymal stem cell injection(HS\\_SW01 Cells injection) in patients with systemic sclerosis, and to further explore its pharmacokinetics(PK), immunological profile and preliminary efficacy.\n\nParticipants will be required to sign the informed consent form and will only be assigned to the study and enrolled after undergoing a series of tests and meeting the inclusion and exclusion criteria of the protocol.",[28],[429,430],"systemic sclerosis","MSC","2026-04-16",{"date":433,"type":33},"2026-04-21",{"date":69,"type":22},{"date":436,"type":22},"2027-12-31",{"name":438,"class":74},"Shenzhen Huishan Biotechnology Co., Ltd.",{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":443,"acronym":444,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":446,"enrollmentInfo":447,"targetDuration":4,"studyType":23,"phases":448,"briefSummary":449,"conditions":450,"keywords":4,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":454,"completionDateStruct":455,"leadSponsor":457,"locationsCount":41},"100634787","phase-1-study-investigating-the-safety-of-anti-cd19-car-t-cells-therapy-produced-at-gustave-roussy-for-adults-with-severe-and-refractory-systemic-autoimmune-rheumatic-diseases-100634787","NCT07544225","Study Investigating the Safety of Anti-CD19 CAR-T Cells Therapy Produced at Gustave Roussy for Adults With Severe and Refractory Systemic Autoimmune Rheumatic Diseases","CELL-ATTACK 1","Inclusion Criteria:\n\n* Adults aged 18-75 with ECOG PS 0-2 with written informed consent, valid health insurance, and eligibility for CAR T cell infusion are required may be included. Patients must have a treatment refractory systemic autoimmune rheumatic disease (RA, SLE, Sjögren's, SSc, or IIM) with severe, progressive activity with adequate renal function (creatinine clearance \\> 30 mL\u002Fmin)\n\nExclusion Criteria:\n\n* Patients with any significant active infection, including hepatitis B or C, HIV, or other opportunistic or recurrent infections, are excluded. Prior gene therapy, previous CAR T treatment, active cancer within 2 years, or any history of allogeneic stem cell or solid organ transplantation exclude participation. Inadequate organ function-renal, hepatic, cardiac (LVEF \\\u003C 50%), or lung function requiring oxygen- and uncontrolled comorbidities prevents inclusion. Pregnancy, breastfeeding, or refusal to use highly effective contraception for 12 months post infusion","75 Years",{"count":75,"type":22},[53],"This is an open-label, single-dose, prospective, monocenter, Phase I interventional study (not first-in-human) to assess the safety, tolerability, and preliminary efficacy of autologous anti-CD19 CAR-T cells as an advanced therapy medicinal product in adult patients; with severe and refractory systemic autoimmune rheumatic diseases, including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), Sjogren's disease (SjD), systemic sclerosis (SSc) and idiopathic inflammatory myositis (IIM).",[58,278,451,28,277],"Sjogren's Disease With Dry Eyes","2026-04-15",{"date":406,"type":33},{"date":215,"type":22},{"date":456,"type":22},"2043-02-01",{"name":458,"class":40},"Gustave Roussy, Cancer Campus, Grand Paris",{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":465,"eligibilityCriteria":466,"healthyVolunteers":140,"sex":18,"minAge":269,"maxAge":467,"enrollmentInfo":468,"targetDuration":4,"studyType":23,"phases":470,"briefSummary":472,"conditions":473,"keywords":482,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":492,"completionDateStruct":493,"leadSponsor":495,"locationsCount":497},"100599701","phase-4-safety-and-immunogenicity-of-the-live-attenuated-tetravalent-butantan-dengue-vaccine-in-autoimmune-rheumatic-diseases-100599701","NCT07087912","Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases","Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine (Butantan-DV) in Patients With Autoimmune Rheumatic Diseases Living in Dengue-Endemic Areas","BTNDV-ARD","Inclusion Criteria:\n\n* Age between 12 and 59 years\n* Male or female\n* Clinical diagnosis of an autoimmune rheumatic disease (ARD) based on internationally accepted criteria (e.g., rheumatoid arthritis, systemic lupus erythematosus, juvenile idiopathic arthritis, Sjögren's syndrome, vasculitis)\n* Healthy control matched by age and sex\n* ARD patients with clinically stable disease for at least 3 months\n* ARD patients under low-grade immunosuppression or no immunosuppression\n* Acceptable immunosuppressive treatments include:\n\nHydroxychloroquine Sulfasalazine Prednisone ≤ 20 mg\u002Fday Methotrexate ≤ 0.4 mg\u002Fkg\u002Fweek (maximum 20 mg\u002Fweek) Leflunomide 20 mg\u002Fday Azathioprine \\\u003C 3 mg\u002Fkg\u002Fday Combination therapy with low-dose prednisone (≤ 7.5 mg\u002Fday), hydroxychloroquine, or sulfasalazine\n\n* Healthy controls with no history of autoimmune or chronic infectious diseases\n* Healthy controls not taking immunosuppressive medications Willing and able to comply with study procedures and follow-up\n* Female participants of reproductive potential with negative pregnancy test at baseline\n* Female participants of reproductive potential agreeing to use effective contraception for at least 90 days after vaccination\n\nExclusion Criteria:\n\n* Prior receipt of any dengue vaccine\n* Receipt of a live attenuated vaccine within 4 weeks prior to enrollment\n* Receipt of an inactivated vaccine within 2 weeks prior to enrollment\n* Known allergy to any component of the vaccine\n* Febrile illness (≥ 37.8°C) within 72 hours prior to vaccination\n* History of immunodeficiency syndromes\n* History of asplenia\n* History of cancer\n* History of HIV infection\n* History of primary immunodeficiencies\n* Immunosuppression due to organ transplant\n* Chronic uncontrolled comorbidities (e.g., heart failure, renal failure, hepatic insufficiency, diabetes mellitus)\n* Hospitalization or acute illness at screening\n* Receipt of blood transfusion within 3 months prior to enrollment\n* Current pregnancy or breastfeeding\n* Intention to become pregnant within 90 days post-vaccination\n* Participation in another clinical trial within 30 days prior to enrollment","59 Years",{"count":469,"type":22},477,[471],"PHASE4","The goal of this clinical trial is to evaluate whether the live attenuated tetravalent Butantan-Dengue vaccine (Butantan-DV) is safe and capable of inducing an immune response in patients aged 12 to 59 years with autoimmune rheumatic diseases (ARDs) who are clinically stable and under low-grade or no immunosuppression, as well as in healthy volunteers matched by sex and age.\n\nThe main questions it aims to answer are:\n\nDoes the vaccine induce adequate seroconversion in patients with ARDs compared to healthy controls? What is the frequency and intensity of common adverse events after vaccination in ARDs patients? Does physical activity levels and nutritional status influence vaccine-induced immune response in patients with ARDs?\n\nResearchers will compare patients with ARDs to healthy controls to evaluate if the vaccine elicits similar immune responses and safety profiles.\n\nAll participants will:\n\n* receive a single 0.5 mL dose of the Butantan-DV vaccine via subcutaneous injection;\n* undergo blood sample collection before and after vaccination (baseline, Day 42, and Day 400) to assess antibody and cellular responses;\n* attend follow-up visits on Days 7, 14, and 42 for safety monitoring and laboratory tests;\n* report any symptoms or adverse events using a standardized diary for 42 days;\n* be followed for up to one year for long-term safety and immunogenicity assessments.\n* wear a device for 14 consecutive days to assess current and habitual physical activity levels.\n* answer three non-consecutive 24-hour dietary recalls, including at least one weekend day to assess nutritional status.\n* collect blood samples one-year after vaccination to access immunogenicity and cellular response.\n\nResearcher will also perform subgroups analysis in:\n\nA viremia subgroup (50 patients and 50 healthy controls) will provide additional samples on Days 1, 7, 14, 28, 42, and-if viremia is detected-Day 68, to evaluate post-vaccination viremia and its duration.\n\nAn immunogenicity subgroup (\\~20% of participants, n=96) will undergo cellular immune response testing via flow cytometry to evaluate T-cell responses.",[58,474,278,475,28,233,476,477,478,479,480,481],"Juvenile Idiopathic Arthritis (JIA)","Juvenile Systemic Lupus Erythematosus","Axial Spondyloarthritis","Psoriatic Arthritis (PsA)","Granulomatosis With Polyangiitis","Microscopic Polyangiitis","Antiphospholipid Syndrome","Takayasu Arteritis",[483,484,485,486,487,488,489],"Tetravalent Vaccine","Butantan-Dengue Vaccine","Autoimmune Rheumatic Diseases","Rheumatology","Pediatric Rheumatology","Infectious Disease Prevention","Vaccine","2026-04-14",{"date":452,"type":33},{"date":35,"type":22},{"date":494,"type":22},"2028-12-30",{"name":496,"class":40},"University of Sao Paulo General Hospital",2,{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":504,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":506,"enrollmentInfo":507,"targetDuration":4,"studyType":23,"phases":509,"briefSummary":510,"conditions":511,"keywords":512,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":41},"100633176","phase-1-safety-and-preliminary-efficacy-of-hn2302-in-patients-with-autoimmune-diseases-100633176","NCT07523282","Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases","A Study to Assess the Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases","AID","Inclusion Criteria:\n\n* Adults aged 18 to 69 years, regardless of gender.\n* Adequate bone marrow, coagulation, cardiopulmonary, hepatic, and renal function.\n* Participants who are not pregnant or breastfeeding and who agree to use effective contraception for 12 months after drug infusion, if applicable.\n* Diagnosis of systemic lupus erythematosus (SLE) according to the 2019 EULAR\u002FACR classification criteria, with a history of SLE for at least 6 months; during screening, participants must have positive antinuclear antibody (ANA), and\u002For positive anti-double-stranded DNA antibody, and\u002For hypocomplementemia.\n* Diagnosis of systemic sclerosis (SSc) according to the 2013 ACR\u002FEULAR classification criteria, including limited cutaneous or diffuse cutaneous systemic sclerosis, with new or progressive skin manifestations within 6 months before screening.\n\nExclusion Criteria:\n\n* Positive hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb) with detectable or quantifiable HBV DNA; positive hepatitis C antibody with detectable or quantifiable HCV RNA; positive HIV antibody; positive CMV DNA; or positive syphilis antigen or antibody.\n* Presence of any other uncontrolled active infection.\n* History of major solid organ transplantation (for example, heart, lung, liver, or kidney transplantation) or bone marrow\u002Fhematopoietic stem cell transplantation.\n* Pregnant or breastfeeding women.\n* Receipt of any mRNA-LNP product or other LNP-based drug within the past 2 years.\n* History, within 6 months before screening, of any of the following cardiovascular conditions: NYHA Class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, ventricular arrhythmia, or other clinically significant cardiac disease.\n* Receipt of a live vaccine within 30 days before screening.\n* History of asthma or severe allergy, if considered clinically significant by the investigator.\n* Any condition that, in the investigator's opinion, would increase risk to the participant or interfere with study assessments.","69 Years",{"count":508,"type":22},12,[53],"This is an open-label, single-arm study designed to evaluate the safety and preliminary efficacy of HN2302 in patients with autoimmune diseases, including systemic lupus erythematosus (SLE) and systemic sclerosis (SSc).",[149,90,28],[513,121],"SLE","2026-04-09",{"date":490,"type":33},{"date":517,"type":22},"2026-04-28",{"date":519,"type":22},"2028-06-30",{"name":521,"class":74},"Shenzhen MagicRNA Biotechnology Co., Ltd",{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":307,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":18,"minAge":309,"maxAge":4,"enrollmentInfo":528,"targetDuration":4,"studyType":23,"phases":529,"briefSummary":530,"conditions":531,"keywords":532,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":41},"100631939","early-phase-1-allogeneic-cd19bcma-car-t-for-b-cell-related-autoimmune-disease-100631939","NCT07507201","Allogeneic CD19\u002FBCMA CAR-T for B Cell-Related Autoimmune Disease","Inclusion Criteria:\n\n* Common Inclusion Criteria:\n* 1.Major organ function must meet the following criteria (exceptions allowed for abnormalities related to autoimmune disease activity):\n* 1)Bone Marrow Function: a. Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL; b. Hemoglobin ≥ 60 g\u002FL; c. Platelet count ≥ 30 × 10⁹\u002FL.\n* 2)Hepatic Function: ALT ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); AST ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); Total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN allowed for Gilbert syndrome).\n* 3)Renal Function: eGFR ≥ 30 mL\u002Fmin\u002F1.73 m².(Participants with eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² and\u002For those receiving renal replacement therapy may be considered eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant or guardian provides fully informed consent.)\n* 4)Cardiac Function: Echocardiography shows no significant structural abnormalities and left ventricular ejection fraction (LVEF) ≥ 55%.\n* 5)Pulmonary Function: No severe pulmonary disease, and SpO₂ ≥ 92%.\n* 2.Women of childbearing potential must use medically acceptable contraception or practice abstinence during the study treatment period and for at least 12 months after the end of study treatment.\n* 3.Informed consent: The participant (and guardian if the participant is a minor) must provide written informed consent, indicating understanding of the study purpose and procedures and willingness to participate.\n* Disease-Specific Inclusion Criteria\n* SLE:\n* 1.Age ≥ 5 years.\n* 2.Meets the 2012 SLICC or 2019 EULAR\u002FACR classification criteria for SLE.\n* 3.Must meet at least one of the following adequate treatment conditions:\n* 1)Active disease persists despite adequate treatment with glucocorticoids (≥1 mg\u002Fkg\u002Fday prednisone or equivalent dose of other corticosteroids) in combination with at least two immunosuppressants or biologic agents for at least 3 months, or affected organ function has failed to improve; or inability to taper glucocorticoid dosage to ≤5 mg\u002Fday after 6 months of conventional treatment;\n* 2)Patients who have developed intolerable drug toxicity during conventional therapy, or have contraindications precluding standard treatment, or have experienced multiple treatment failures-may be considered for enrollment following full informed consent by the investigator and the patient or legal guardian;\n* 3)SLEDAI-2K Criteria: SLEDAI-2K score ≥8; or SLEDAI-2K score ≥6 combined with at least one BILAG-2004 Category A or two Category B organ system involvements (or both).\n* 4.No occurrence of macrophage activation syndrome within 1 month prior to screening.\n* 5.Occurrence of CNS lupus symptoms requiring intervention within 60 days prior to screening, including seizures, psychosis, cerebrovascular events, etc.\n* MDR-SRNS\n* 1.Age ≥3 years old, gender unlimited.\n* 2.Diagnosed with SRNS according to the 2021 Kidney Disease: Improving Global Outcomes #KDIGO# Guidelines;\n* 3\\. Must meet at least one of the following adequate treatment conditions:\n* a) have not achieved a complete response after 12 months of treatment with two standard doses of hormone replacement drugs with different mechanisms of action or relapse of disease activity after remission(at least one of the two drugs is a calcineurin inhibitor such as cyclosporine or tacrolimus, Other replacement drugs include Mycophenolate Mofetil, cyclophosphamide, Taitacept or rituximab).\n* b) if no remission has been achieved after 3 to 6 months of adequate treatment with one calcineurin- inhibitor. The researcher judges that the benefits outweigh the risks and the patient or guardian has fully informed consent, the patient can be considered for inclusion.\n* c) Patients unable to tolerate conventional therapy may be eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant (or guardian if minor) provides fully informed consent.\n* d) Patients with other diseases, such as systemic lupus erythematosus, requiring long-term systemic treatment with glucocorticoids or immunosuppressants, may be considered for inclusion after the investigator determines that the benefits outweigh the risks, and the patient or guardian has fully informed consent.\n* 4.Renal biopsy was performed and the pathological type was determined to be minimal lesion nephropathy(MCD) or focal segmental glomerulosclerosis (FSGS);\n* IgA nephropathy\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. IgA nephropathy pathologically confirmed by renal biopsy;\n* 3\\. Angiotensin-Converting Enzyme Inhibitors (ACEI) or angiotensin receptor blocker (ARB) treated for at least 3 months and meet at least one of the following requirements:\n* a) Combination or sequential treatment with steroids and at least one immunosuppressant or biologic for ≥ 3 months; and 24-hour urine protein quantification ≥500mg or UPCR≥0.5mg\u002Fmg;\n* b) \\>50% decline in eGFR within 3 months;\n* c) Patients who are unable to tolerate conventional treatment and for whom the investigator determines the benefits outweigh the risks and who have obtained fully informed consent from the patient or guardian may be considered for inclusion;\n* 4\\. Exclude subjects with other secondary causes; exclude patients with uncontrolled blood pressure.\n* Systemic Sclerosis:\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. Scleroderma fulfilling the 2013 ACR classification criteria\n* 3\\. Positive scleroderma-related antibodies.\n* 4\\. Modified Rodnan Skin Score (mRSS) ≥ 15 (total score 51).\n* 5\\. Must meet at least one of the following adequate treatment conditions:\n* a) Treated with glucocorticoids (≥0.5 mg\u002Fkg\u002Fday) plus at least one immunomodulatory agent (including antimalarials, cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or biologics such as rituximab, belimumab, thalidomide) for more than 3 months without significant improvement.\n* b) Meets criteria for rapidly progressive disease and is unresponsive to standard therapy; participant may be enrolled if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n* c) Patients unable to tolerate conventional therapy may be eligible if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n* 6\\. Presence of severe pulmonary arterial hypertension (PAH), defined as a mean pulmonary arterial pressure \\>45 mmHg, or other severe involvement of major organs will be exclude.\n* Refractory\u002FRelapsed ANCA-Associated Vasculitis:\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. Meets the diagnostic criteria for ANCA-associated vasculitis according to the 2007 European Medicines Agency (EMA) algorithm or the 2022 ACR\u002FEULAR classification criteria, including microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA).\n* 3\\. Refractory AAV is defined as: a reduction in the Birmingham Vasculitis Activity Score (BVAS) of less than 50%, a persistent score of ≥ 3, or the occurrence of new organ involvement following ≥3 months of standard induction therapy (including glucocorticoids in combination with Rituximab \\[RTX\\] or Cyclophosphamide \\[CYC\\]) ; or a worsening of the disease during maintenance therapy or after treatment discontinuation following the achievement of remission (BVAS = 0), which necessitates the re-initiation of induction therapy;\n* 4\\. Or meets the criteria for severe vasculitis, with inadequate response to standard-of-care therapy, and may be considered for enrollment if the investigator determines that the potential benefits outweigh the risks and the patient or legal guardian provides fully informed consent.\n* 5\\. Evidence of active vasculitis meeting the following criteria: For participants \\\u003C18 years of age: Pediatric Vasculitis Activity Score (PVAS) ≥10 (total score 63); For participants ≥18 years of age: Birmingham Vasculitis Activity Score (BVAS) ≥10 (total score 63); indicating active vasculitis.\n* 6\\. Exclusion Criterion: Presence of alveolar hemorrhage requiring ventilatory support for more than one week.\n\nExclusion Criteria:\n\n* 1\\. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, tocilizumab), or subjects with a history of severe allergic reactions.\n* 2.Subjects with grade III or IV heart failure (NYHA classification).\n* 3.Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs.\n* 4\\. Uncontrollable infection, or active infection that requires systemic treatment at screening.\n* 5\\. Had active pulmonary tuberculosis at screening.\n* 6\\. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive; Or cytomegalovirus (CMV) DNA test positive.\n* 7\\. History of severe herpes infection prior to screening, such as herpetic encephalitis, ocular herpes, or disseminated herpes; Signs of herpes or varicella-zoster virus infection (especially chickenpox, shingles) within 12 weeks prior to screening.\n* 8\\. Patients had active central nervous system disease.\n* 9\\. Patients with malignant diseases such as tumors before screening.\n* 10\\. Secondary or congenital immunodeficiency.\n* 11\\. History of any cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal disease or other major medical condition that would prevent the administration of QT-019B, except for lupus.\n* 12\\. Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; Acute graft-versus host disease (GVHD) of grade 2 or above was present within 2 weeks prior to screening.\n* 13\\. Received live vaccine within 4 weeks before screening.\n* 14\\. Tested positive in Blood pregnancy test.\n* 15\\. Patients who had participated in other clinical trials and received any intervention within 3 months before enrollment.\n* 16\\. Any abnormal laboratory test results judged by the investigator to be clinically significant and prevent the subject from participating in the study. Laboratory test values that are out of range and not of clinical significance will not be considered as exclusion criteria.\n* 17\\. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.",{"count":85,"type":22},[87],"This is an exploratory, open-label, single-arm Phase 1 clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of QT-219C. QT-219C is a universal allogeneic chimeric antigen receptor T-cell (CAR-T) product targeting both CD19 and BCMA. The study targets subjects with refractory B-cell-related autoimmune diseases, including systemic lupus erythematosus (SLE), multi-drug resistant nephrotic syndrome (NS), IgA nephropathy (IgAN), systemic sclerosis (SSc), and ANCA-associated vasculitis (AAV) .The research is divided into two phases: a dose-escalation phase and a dose-expansion phase. Dose Escalation: Utilizes a standard \"3+3\" design to evaluate potential recommended dose(RD) and identify dose-limiting toxicities (DLTs) .Treatment Procedure: Eligible subjects will receive a lymphodepleting conditioning regimen followed by a single intravenous infusion of QT-219C .Primary Objectives: The primary goals are to evaluate the safety profile, including the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and to assess clinical response rates at 90 days post-infusion .Follow-up: Subjects will be monitored for pharmacokinetics (cell expansion), pharmacodynamics (B-cell depletion), and long-term safety for up to two years .",[292,314,315,316,28,317],[319,315,533,534,28,92],"Systemic Lupus Erthematosus","IgAN - IgA Nephropathy","2026-03-30",{"date":537,"type":33},"2026-04-02",{"date":539,"type":22},"2026-04-01",{"date":541,"type":22},"2029-12",{"name":329,"class":40},{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":4,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":550,"enrollmentInfo":551,"targetDuration":4,"studyType":23,"phases":553,"briefSummary":554,"conditions":555,"keywords":556,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":41},"100579329","phase-1-ct1190b-in-the-treatment-of-patients-with-moderate-to-severe-refractory-systemic-lupus-erythematosus-sle-or-refractoryprogressive-systemic-sclerosis-ssc-100579329","NCT06822881","CT1190B in the Treatment of Patients With Moderate to Severe Refractory Systemic Lupus Erythematosus (SLE) or Refractory\u002FProgressive Systemic Sclerosis (SSc)","A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT1190B CAR-T Cell Therapy, in Patients With Moderate to Severe Refractory Systemic Lupus Erythematosus (SLE) or Refractory\u002FProgressive Systemic Sclerosis (SSc)","Inclusion Criteria:\n\n1. Voluntary signing of the Informed Consent Form (ICF)\n2. Age range: At the time of signing the ICF, the age is between 18 and 60 years old (including 18 and 60 years old), regardless of gender.\n3. No systemic active infection within 2 weeks before screening.\n4. Contraceptive requirements for participants with child - bearing potential.\n5. Negative pregnancy test for women with child - bearing potential. Inclusion Criteria for SLE\n\n\u003C!-- -->\n\n1. Meet the EULAR\u002FACR 2019 SLE classification criteria with a disease history ≥ 6 months.\n2. Treatment and disease activity requirements:\n\n   o Before screening, the participant must have received treatment with glucocorticoids combined with immunosuppressive agents (including cyclophosphamide, mycophenolate mofetil, tacrolimus, methotrexate, cyclosporine, leflunomide) and\u002For biological agents for ≥ 3 months, with a stable dose for ≥ 2 weeks, and the disease is still in an active state. Oral corticosteroid requirements at the time of screening:\n\n   o If treated with corticosteroids alone, prednisone (or equivalent drug) ≥ 7.5 mg\u002Fday.\n\n   o When used in combination with immunosuppressive agents and\u002For biological agents, there is no minimum daily dose requirement for corticosteroids.\n3. Positive antibody test at screening: Positive antinuclear antibody, and\u002For positive anti-ds-DNA antibody, and\u002For positive anti-Smith antibody.\n4. Disease activity score or organ damage: At the screening stage, the SLEDAI - 2K score is ≥ 7 points\n5. Active organ involvement at screening: isolated skin and mucous membrane involvement is not eligible for inclusion.\n6. Adequate organ function:\n\n   o Renal function: Defined as a calculated creatinine clearance rate (Cockcroft - Gault) ≥ 50 mL\u002Fmin without the need for hydration assistance.\n\n   o Bone marrow function: Defined as absolute neutrophil count (ANC) ≥ 1.0×10⁹\u002FL and hemoglobin (Hb) ≥ 60 g\u002FL. Blood transfusion and growth factors should not be used to meet these requirements within 7 days before the inclusion and exclusion screening.\n\n   o Liver function: Defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2× the upper limit of normal (ULN), and total bilirubin ≤ 2× the upper limit of normal (ULN).\n\n   o Coagulation function: Defined as international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5×ULN.\n\n   o Lung function: Oxygen saturation (SpO₂) ≥ 92% (measured by pulse oximeter) in room air.\n   * Cardiac function: Defined as a left ventricular ejection fraction (LVEF) ≥ 40% as evaluated by echocardiogram (ECHO) within 8 weeks before screening.\n\nInclusion Criteria for SSc\n\n1. Meet the 2013 EULAR\u002FACR classification criteria for systemic sclerosis and the diffuse - type manifestation simultaneously.\n2. Combined with interstitial pneumonia caused by SSc.\n3. Meet the definition of refractory or progressive disease:\n\n   o Refractory disease definition: Ineffective after more than 6 months of conventional treatment, or disease recurrence after remission. Conventional treatment is defined as the use of glucocorticoids (more than 1 mg\u002Fkg\u002Fd) or cyclophosphamide, and one or more of the following immunomodulatory drugs: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents including Actemra, Rituxan, belimumab, tabitacicept, etc.\n   * Progressive disease definition (in the past 6 months):\n   * Skin progression: An increase in mRSS \\> 10%.\n   * Lung disease progression: A 10% decrease in FVC, or a 5% decrease in FVC accompanied by a 15% decrease in DLCO.\n4. Important organ function:\n\n   o Renal function: Defined as a calculated creatinine clearance rate (Cockcroft - Gault) ≥ 50 mL\u002Fmin without the need for hydration assistance.\n\n   o Bone marrow function: Defined as absolute neutrophil count (ANC) ≥ 1.0×10⁹\u002FL and hemoglobin (Hb) ≥ 90 g\u002FL. Blood transfusion and growth factors should not be used to meet these requirements within 7 days before the inclusion and exclusion screening.\n\n   o Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2× the upper limit of normal (ULN), and total bilirubin ≤ 2× the upper limit of normal (ULN).\n\n   o Coagulation function: INR ≤ 1.5×ULN, prothrombin time (PT) ≤ 1.5×ULN.\n\n   o Cardiac function: Good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥ 40%.\n\nExclusion Criteria:\n\n1. Previous history of CAR-T cell or other genetically modified T-cell therapies, or previous major organ transplantation.\n2. Use of B-cell targeted drugs (such as rituximab) within 2 months before screening.\n3. Allergy or intolerance to lymphodepletion drugs, tocilizumab, or life-threatening allergic reactions, hypersensitivity reactions, or intolerance to the CT1190B preparation or its excipients, or a history of other severe allergies such as anaphylactic shock.\n4. Use of corticosteroids ≥ 10 mg\u002Fday of prednisone (or equivalent drug) within 10 days before the infusion of CT1190B.\n5. Use of immunosuppressive agents that affect T-cells (mycophenolate mofetil, methotrexate, cyclosporine, azathioprine, leflunomide, tacrolimus) within 10 days before the infusion of CT1190B.\n6. Use of JAK inhibitors (tofacitinib, baricitinib tablets, ruxolitinib, etc.) within 3 days before the infusion of CT1190B.\n7. Vaccination with live-attenuated vaccines, inactivated vaccines, or RNA vaccines within 1 month before screening.\n8. Diagnosis of cancer within 2 years before signing the ICF. Exceptions include non-melanoma skin cancer treated by radical therapy, local prostate cancer, biopsy-proven cervical carcinoma in situ or squamous intraepithelial lesions detected by cervical smear, and completely resected breast carcinoma in situ.\n9. Undergoing major surgery within 4 weeks before signing the ICF, or planning to undergo major surgery during the study, and the investigator deems it will pose an unacceptable risk to the participant.\n10. Positive test for HIV, syphilis, active hepatitis B virus infection, or active hepatitis C virus infection at screening.\n11. History of central nervous system diseases before screening, including but not limited to cerebrovascular accident, encephalitis, epilepsy, convulsions\u002Fseizures, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar diseases, central nervous system vasculitis, cognitive impairment, organic brain syndrome, or mental illness.\n12. History of any of the following cardiovascular diseases within 1 month before screening: Heart failure of class III or IV as defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia, or other heart diseases of significant clinical significance.\n13. Participation in other clinical studies within 3 months before screening or still within five half-lives after the last dose of the drug.\n14. Current presence of any uncontrolled active infection, including but not limited to active tuberculosis, etc.\n15. History or evidence of suicidal thoughts within 6 months before signing the ICF, or any suicidal behavior within the previous 12 months, and the investigator deems there is a significant suicide risk.\n16. Pregnant or breastfeeding women.\n17. Poor compliance judged by the investigator, inability or unwillingness to comply with the requirements of the study protocol, or other reasons that make the participant unsuitable for this clinical study.\n\nExclusion Criteria for SLE\n\n1. Severe lupus nephritis within 2 months before screening, requiring hemodialysis, or receiving prednisone ≥ 100 mg\u002Fd or equivalent corticosteroid treatment for ≥ 14 days.\n2. Lupus crisis within 1 month before screening, and the investigator deems it inappropriate for the participant to participate in this study.\n3. Central nervous system manifestations caused by lupus before screening, including but not limited to lupus headache, seizures, cognitive impairment, impaired intellectual function, visual impairment, etc.\n4. History of ≥ grade 2 bleeding within 30 days before screening.\n5. Plasmapheresis, plasma separation, or hemodialysis within 14 days before screening.\n\nExclusion Criteria for SSc\n\n1\\. FVC ≤ 30% of the predicted value or DLCO (corrected for hemoglobin) ≤ 30% of the predicted value.\n\n2\\. Combined with severe kidney disease or signs of renal crisis in the participant.\n\n3\\. Risk of active tuberculosis at screening.","60 Years",{"count":552,"type":22},27,[53],"A Clinical Study Exploring CT1190B in the treatment of patients with moderate to severe refractory systemic lupus erythematosus (SLE) or refractory\u002Fprogressive systemic sclerosis (SSc)",[278,28],[557],"CT1190B","2026-03-06",{"date":560,"type":33},"2026-03-10",{"date":562,"type":33},"2025-02-20",{"date":564,"type":22},"2026-12-31",{"name":566,"class":40},"Beijing GoBroad Hospital",{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":572,"acronym":4,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":83,"enrollmentInfo":574,"targetDuration":4,"studyType":23,"phases":576,"briefSummary":577,"conditions":578,"keywords":583,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":586,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":591,"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":575,"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 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.",[278,579,28,580,581,582],"Lupus Nephritis (LN)","Inflammatory Myopathy","Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis","Antiphospholipid Syndrome (APS)",[584],"Relapsing\u002FRefractory Autoimmune Diseases","2026-02-27",{"date":587,"type":33},"2026-03-02",{"date":589,"type":33},"2025-08-04",{"date":494,"type":22},{"name":592,"class":74},"China Immunotech (Beijing) Biotechnology Co., Ltd.",{"id":594,"slug":595,"hasResults":12,"nctId":596,"briefTitle":597,"officialTitle":598,"acronym":4,"eligibilityCriteria":599,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":600,"targetDuration":4,"studyType":200,"phases":4,"briefSummary":602,"conditions":603,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":606,"startDateStruct":608,"completionDateStruct":610,"leadSponsor":611,"locationsCount":41},"100610503","quantification-of-calcinosis-cutis-disease-burden-using-computed-tomography-images-100610503","NCT07228429","Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images","Quantification of Calcinosis Cutis Disease Burden in Patients With Systemic Sclerosis Using Computed Tomography Images","Inclusion Criteria:\n\n* Scleroderma\u002Fsystemic sclerosis patient with diagnosed calcinosis cutis who will be clinically treated with STS as they would in clinical SOC care\n* Must be ≥ 18 years old and meet the 2013 American College of Rheumatology criteria for the diagnosis of systemic sclerosis (diffuse or limited)\n* Receiving clinical care at Yale clinics\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Currently pregnant or nursing\n* Patients with a calcinosis ROI \\>6cm",{"count":601,"type":22},56,"The main purpose of this study is to develop sensitive radiographic measurement techniques that can be used as outcome measures along with patient-reported outcome instruments in clinical trials of calcinosis cutis treatments, and potentially be used to assess disease course and treatment response in clinical practice. The goal is to test the performance of the software.",[28,604],"Calcinosis Cutis","2026-02-11",{"date":607,"type":33},"2026-02-17",{"date":609,"type":33},"2025-10-14",{"date":185,"type":22},{"name":612,"class":40},"Yale University",{"id":614,"slug":615,"hasResults":12,"nctId":616,"briefTitle":617,"officialTitle":618,"acronym":4,"eligibilityCriteria":619,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":446,"enrollmentInfo":620,"targetDuration":4,"studyType":23,"phases":622,"briefSummary":623,"conditions":624,"keywords":625,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":633,"lastUpdatePostDateStruct":634,"startDateStruct":636,"completionDateStruct":638,"leadSponsor":639,"locationsCount":641},"100580894","phase-2-tibulizumab-systemic-sclerosis-understanding-and-response-evaluation-tibusure-100580894","NCT06843239","Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)","A Phase 2, Multi-Center Study Consisting of a Randomized, Double-Blind, Placebo-Controlled Period, Followed by an Open-Label Extension Period, to Assess the Efficacy, Safety, and Tolerability of Tibulizumab in Adults With Systemic Sclerosis","Inclusion Criteria:\n\n* Male or female, 18 to 75 years of age\n* Body mass index between 18.0 and 38.0 kg\u002Fm²\n* Fulfills classification criteria for SSc according to ACR\u002FEULAR 2013 criteria\n* Has diffuse cutaneous SSc, defined as mRSS \\>0 over at least one skin area proximal to the elbows and\u002For knees, in addition to acral fibrosis\n* Has had SSc (defined as the first non-Raynaud's phenomenon (RP) symptom or sign attributed to SSc) for ≤7 years\n* mRSS ≥15 and ≤45 at screening. Additional requirements for participants ≥2 years to ≤7 years from SSc onset and RNA Polymerase III antibody positive\n* FVC \\>50% predicted\n* Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥40% predicted (corrected for hemoglobin)\n\nExclusion Criteria:\n\n* Has any of the following complications:\n\n  * Left ventricular failure\n  * Pulmonary arterial hypertension\n  * Renal crisis within previous 6 months\n  * Gastrointestinal dysmotility within previous 3 months\n  * Digital ischemia with gangrene, amputation, or unscheduled hospitalization within previous 3 months\n* Current rheumatic disease other than SSc that could interfere with assessment of SSc\n* Lung disease requiring continuous oxygen therapy\n* Evidence or suspicion of active or latent tuberculosis\n* Active Crohn's Disease or ulcerative colitis",{"count":621,"type":22},80,[54],"The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 24 weeks (Period 1) in adult participants with systemic sclerosis, followed by an open-label extension period where all active participants will receive tibulizumab and will be evaluated for an additional 28 weeks (Period 2)",[28,118],[118,28,626,627,628,629,630,631,632],"Tibulizumab","Cutaneous","Interstitial lung disease (ILD)","Autoimmune diseases","Immune system diseases","Systemic Sclerosis interstitial lung disease (SSC-ILD)","Skin Diseases","2026-02-10",{"date":635,"type":33},"2026-02-12",{"date":637,"type":33},"2025-02-06",{"date":129,"type":22},{"name":640,"class":74},"Zura Bio Inc",51,{"id":643,"slug":644,"hasResults":12,"nctId":645,"briefTitle":646,"officialTitle":647,"acronym":648,"eligibilityCriteria":649,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":83,"enrollmentInfo":650,"targetDuration":4,"studyType":23,"phases":651,"briefSummary":652,"conditions":653,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":654,"lastUpdatePostDateStruct":655,"startDateStruct":656,"completionDateStruct":658,"leadSponsor":660,"locationsCount":41},"100624723","phase-1-a-clinical-study-of-ti-0032-iii-injection-in-patients-with-relapsed-and-refractory-autoimmune-diseases-100624723","NCT07413341","A Clinical Study of TI-0032-III Injection in Patients With Relapsed and Refractory Autoimmune Diseases","A Clinical Study on the Safety and Efficacy of in Vivo CAR-T Cell Therapy (TI-0032-III Injection) for the Treatment of Relapsed and Refractory Autoimmune Diseases","in vivo CAR-T","Inclusion Criteria:\n\n* Understand trial procedures and methods, voluntarily sign the informed consent form .\n* Age ranges from 18 to 65 years old (including threshold), regardless of gender.\n* Positive expression of CD19 on peripheral blood B cells determined by flow cytometry.\n* Bone marrow function: neutrophil count ≥ 1.5 × 10\\^9\u002FL, lymphocyte count ≥ 0.8 × 10\\^9\u002FL, hemoglobin ≥ 90 g\u002FL, platelet ≥ 100 × 10\\^9\u002FL. Blood transfusion and growth factors must not be used within 14 days prior to screening to meet the above requirements.\n* Coagulation function: international normalized ratio or activated partial thromboplastin time ≤ 1.5× upper limit of normal range (ULN).\n* Cardiopulmonary function: left ventricular ejection fraction ≥ 50% on echocardiography; for lung function, dyspnea ≤Grade 1 of the NCI-CTCAE version 5.0 standards when breathing room air, and pulse oximetry ≥ 92%.\n* Liver function: alanine aminotransferase ≤ 1.5 × ULN, aspartate aminotransferase ≤ 1.5 × ULN, total bilirubin ≤ 1.5 × ULN (total bilirubin at least ≤ 3.0 mg\u002FdL in patients with Gilbert syndrome).\n* Renal function: creatinine clearance (by Cockcroft-Gault formula) ≥ 50 mL\u002Fmin.\n* Criteria for SLE：\n\n  1. Meet the 2019 European Alliance of Associations for Rheumatology\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for SLE;\n  2. SLEDAI-2000 score \\> 6 in the moderate to severe active phase of the disease;\n  3. And have at least one British Isles Lupus Assessment Group (BILAG-2004) grade A (severe manifestation) or two grade B (moderate manifestation) organ scores, or both.\n  4. Ineffective conventional treatment or relapse of disease activity after remission. Definition of routine treatment: Use of glucocorticoids (Above 1 mg\u002Fkg\u002Fd) and cyclophosphamide, and any of the following immunomodulatory drugs for more than 6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics such as rituximab, belimumab, and telitacicept.\n* Criteria for Sjögren's syndrome:\n\n  1. Meet the 2002 AECG criteria for primary Sjögren's syndrome or the 2016 ACR\u002FEULAR classification criteria;\n  2. Disease activity ESSDAI ≥ 6;\n  3. Anti-SSA\u002FRo antibody positive;\n  4. Definition of relapse\u002Frefractory: disease activity that is ineffective to conventional treatment for more than 6 months or recurs after response. Definition of conventional treatment is use of glucocorticoids and cyclophosphamide, and any of the following immunomodulatory drugs: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, and telitacicept.\n* Criteria for systemic sclerosis:\n\n  1. Meet the 2013 ACR classification criteria for systemic sclerosis and meet diffuse manifestations;\n  2. Combined interstitial pneumonia: interstitial changes with ground-glass exudate detected by chest high-resolution computed tomography (HRCT);\n\n     Needs to be met c. or d.:\n  3. Ineffective conventional treatment or relapse of disease activity after remission. Definition of routine treatment: Use of glucocorticoids (Above 0.5 mg\u002Fkg\u002Fd) and cyclophosphamide, and any of the following immunomodulatory drugs for more than 6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics such as rituximab and belimumab.\n  4. Meet the definition of progression: 1) Definition of skin progression: mRSS increases b \\> 25%; 2) Definition of lung disease progression: FVC decreased by 10%, or FVC decreased by 5% and DLCO decreased by 15%.\n* Criteria for inflammatory myopathy:\n\n  1. The classification criteria for inflammatory myopathy comply with the 2017 EULAR\u002FACR (including DM, PM, ASS and NM);\n  2. For patients with muscle involvement, the MMT-8 score is less than 142 and abnormalities are found in at least two of the following five core measures (PhGA, PtGA, or extramuscular disease activity score ≥ 2 points; total HAQ score ≥ 0.25; muscle enzyme level is 1.5 times upper limit of normal);\n  3. Myositis antibody positive;\n\n     Needs to be met d. or e.:\n  4. Definition of relapse\u002Frefractory: Failure of conventional treatment or relapse of disease activity after response. Definition of conventional treatment: Use of glucocorticoids (greater than 1 mg\u002Fkg\u002Fd) and cyclophosphamide, and any of the following immunomodulatory drugs for more than 6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics such as rituximab and belimumab.\n  5. Meet the definition of progression: Interstitial pneumonia progresses rapidly over a short period of time.\n* Criteria for ANCA-associated vasculitis:\n\n  1. Meet the diagnostic criteria for ANCA-associated vasculitis in the 2022 ACR\u002FEULAR, including microscopic polyangiitis, granulomatous polyangiitis, eosinophilic granulomatosis with polyangiitis;\n  2. ANCA-related antibody positive (MPO-ANCA or PR3-ANCA positive);\n  3. Birmingham Vasculitis Activity Scale (BVAS) ≥ 15 points (out of a total of 63 points), indicating activity of vasculitis;\n  4. Must have at least one major item, at least three minor items, or at least two renal items, hematuria and proteinuria, in the BVAS assessment;\n  5. Definition of relapse\u002Frefractory: Failure of conventional treatment or relapse of disease activity after response. Definition of conventional treatment: Use of glucocorticoids (greater than 1 mg\u002Fkg\u002Fd) and cyclophosphamide, and any of the following immunomodulatory drugs for more than 6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics such as rituximab and belimumab.\n\nExclusion Criteria:\n\n* Prohibited medications and treatments:\n\n  * Any RNA-LNP products or other LNP drugs received within the past two years.\n  * Received intravenous gamma immunoglobulin within 24 weeks prior to screening.\n  * Received plasmapheresis therapy within 12 weeks prior to screening.\n  * Subjects who have not fully recovered from surgery within 4 weeks prior to screening.\n  * Epilepsy or use of psychotropic or sedative drugs during the screening period (except medications for sleeping).\n  * Received any live or live attenuated vaccine within 12 weeks prior to screening, or requiring vaccination at any time during clinical trial treatment.\n  * Participated in clinical trial of other drugs or medical devices within 12 weeks prior to screening (except for those whose screening failed).\n* Concomitant diseases or clinical condition:\n\n  * History of lupus nephropathy requiring hemodialysis or treatment with high-dose corticosteroids (\\> 100 mg\u002Fd prednisone or equivalent) within 90 days prior to baseline.\n  * Epilepsy or use of psychotropic or sedative drugs during the screening period (except medications for sleeping).\n  * Received any live or live attenuated vaccine within 12 weeks prior to screening, or requiring vaccination at any time during clinical trial treatment.\n  * Participated in clinical trial of other drugs or medical devices within 12 weeks prior to screening (except for screen failures).\n  * Have active central nervous system lupus, including meningitis aseptic, cerebral vasculitis, demyelinating syndrome, myelopathy, acute demented, psychosis, acute inflammatory demyelinating polyradiculoneuropathy, mononeuropathy (single\u002Fmultiple), cranial neuropathy, plexopathy, status epilepticus or cerebellar ataxia.\n  * Presence of other systemic inflammations such as, but not limited to, rheumatoid arthritis, juvenile chronic arthritis, spondyloarthritis, Crohn's disease, ulcerative colitis, or psoriatic arthritis within 12 weeks prior to screening (except for those with secondary Sjögren's syndrome, who should not be excluded).\n  * Subjects who have Grade III or above congestive heart failure (NYHA grade), unstable angina or myocardial infarction, poorly controlled hypertension (hypertension is diagnosed as Grade 2 or above, risk factor stratified as high-risk, systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg when taking one or two antihypertensive drugs, cerebrovascular accidents, or arrhythmias requiring treatment within 6 months prior to screening.\n  * Presence of active or uncontrolled infection requiring treatment; or have known or suspected ongoing, chronic, or recurrent infectious diseases (including but not limited to opportunistic infections such as pulmonary tuberculosis, atypical mycobacterosis, listeriosis or aspergillosis, HIV, hepatitis B or hepatitis C, etc.).\n  * Subjects with suspected allergy to TI-0032-III or similar drugs or a history of severe allergy or hypersensitivity reactions.\n  * History of thyrotoxicosis, including but not limited to diffuse toxic goitre, multinodular toxic goiter, thyroid autonomic high-function adenoma, and subacute thyroiditis, or thyroid color ultrasound suggests thyroid nodules TI-RADS classification as category 4 or 5.\n  * Previous history of splenectomy or loss of spleen function after splenic infarction or splenic vein thrombosis leading to direct vascular injury; or major surgery within 2 months prior to screening; or have planned surgery before the end of the trial.\n  * Have other serious\u002Fsevere acute or chronic mental illness, including recent (within the past 1 year) or current suicidal ideation or behavior; or a history of alcohol, drug, or chemical abuse within 1 year prior to screening.\n  * History of major organ transplant (e.g., heart, lung, liver, kidney) or bone marrow\u002Fhematopoietic stem cell transplantation.\n  * History of malignancy, regardless of evidence of local recurrence or metastasis and regardless of treatment; or accompanied by a history of other major diseases, such as liver disease under treatment, including but not limited to acute or chronic hepatitis, liver cirrhosis or liver failure, etc.\n  * HIV positive, or active hepatitis B virus test positive (HBsAg positive, HBV-DNA ≥ 200 copies\u002FmL is required (conversion is required if HBV-DNA is in IU\u002FmL)), or anti-HCV antibody positive and HCV-RNA positive.\n  * Women who plan to become pregnant or are pregnant or breastfeeding; or blood pregnancy test positive during screening; or unable to take effective contraceptive measures within 12 months after the last infusion of investigational drug; or planned sperm\u002Fegg donation within 12 months after the last dose of the investigational drug.\n  * Other clinically significant abnormal laboratory tests or imaging tests judged by the investigator or considered unsuitable for clinical the trial for other reasons.",{"count":508,"type":22},[53],"This is an open-label, dose escalation study in patients with relapsed and refractory autoimmune diseases. Study drug, TI-0032-III injection, is composed of lipid nanoparticles (LNPs) targeting T cells that encapsulate circular RNA encoding the CD19 chimeric antigen receptor (CAR), which is a therapeutic biological product. It is clinically intended for the treatment of various relapsed and refractory B cell-related autoimmune diseases, such as systemic lupus erythematosus, sjögren's syndrome, systemic sclerosis, idiopathic inflammatory myositis, and antiphospholipid syndrome.",[278,93,28,580,317],"2026-02-09",{"date":607,"type":33},{"date":657,"type":33},"2026-01-22",{"date":659,"type":22},"2027-01-30",{"name":661,"class":74},"Therorna",{"id":663,"slug":664,"hasResults":12,"nctId":665,"briefTitle":666,"officialTitle":666,"acronym":667,"eligibilityCriteria":668,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":669,"targetDuration":4,"studyType":200,"phases":4,"briefSummary":671,"conditions":672,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":677,"lastUpdatePostDateStruct":678,"startDateStruct":679,"completionDateStruct":681,"leadSponsor":683,"locationsCount":41},"100623942","a-long-term-follow-up-study-for-participants-previously-treated-with-kyv-101-100623942","NCT07403188","A Long-Term Follow-Up Study for Participants Previously Treated With KYV-101","KYSA-4","Inclusion Criteria:\n\n* Provided informed consent for the LTFU study\n* Received at least 1 infusion of KYV-101 as part of a previous KYV-101 parent treatment protocol\n\nExclusion Criteria:\n\n* Not applicable",{"count":670,"type":22},70,"The purpose of this long-term follow-up (LTFU) study is to collect delayed adverse events (AEs) and understand the persistence of KYV-101 (autologous CAR T cell product; gene-modified product), in participants who have been administered KYV-101 (gene-modified product; autologous CAR T cell product).\n\nThis LTFU protocol will be open to any participant who received at least one infusion of KYV-101 in a previous Kyverna sponsored clinical trial or Investigator Initiated Trial (IIT).",[673,674,675,58,676,342,28],"Refractory Lupus Nephritis","Myasthaenia Gravis","Stiff Person Syndrome","Multiple Sclerosis","2026-02-03",{"date":605,"type":33},{"date":680,"type":33},"2025-11-24",{"date":682,"type":22},"2041-01",{"name":684,"class":74},"Kyverna Therapeutics",{"id":686,"slug":687,"hasResults":12,"nctId":688,"briefTitle":689,"officialTitle":690,"acronym":691,"eligibilityCriteria":692,"healthyVolunteers":140,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":693,"targetDuration":4,"studyType":200,"phases":4,"briefSummary":695,"conditions":696,"keywords":697,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":702,"lastUpdatePostDateStruct":703,"startDateStruct":705,"completionDateStruct":707,"leadSponsor":708,"locationsCount":41},"100623175","correlation-between-circulating-fibroblast-activation-protein-fap-and-fibrosis-in-two-diseases-rheumatoid-arthritis-and-systemic-sclerosis-100623175","NCT07393217","Correlation Between Circulating Fibroblast Activation Protein (FAP) and Fibrosis in Two Diseases (Rheumatoid Arthritis and Systemic Sclerosis)","Circulating Fibroblast Activation Protein (FAP) As A Marker for Fibroblast-Driven Pathology in Rheumatoid Arthritis and Systemic Sclerosis : Implication for Joint, Skin and Lung Fibrosis","FAP","Inclusion Criteria:\n\n* Age ≥18 years. Confirmed diagnosis of RA (ACR\u002FEULAR) or SSc (ACR\u002FEULAR).\n* Ability and willingness to provide informed consent. Cooperative patient able to answer questions.\n\nExclusion Criteria:\n\n* Patients under 18 years' old\n* Active cancer or history of cancer within 5 years.\n* Other major fibrotic systemic disease that could confound circulating FAP levels.\n* Acute infection at time of sampling.\n* Pregnancy or breastfeeding.\n* Other autoimmune diseases",{"count":694,"type":22},111,"This study aims to measure a blood protein called fibroblast activation protein (FAP), which is linked to tissue scarring and inflammation. A small blood sample will be taken from participants (RA , SSc patients and healthy people ), and the FAP level will be measured and compared with routine clinical examinations, imaging studies, and lung function tests.\n\nThe purpose of this study is to improve understanding of disease activity and lung involvement in these conditions and to explore whether FAP could be useful as a blood marker for future patients. Participation in this study will not change the participant's usual medical care.",[58,28],[698,699,429,700,701],"Fibroblast Activation protein","Rheumatoid Arthritis","lung fibrosis","skin fibrosis","2026-01-31",{"date":704,"type":33},"2026-02-06",{"date":706,"type":22},"2026-03-01",{"date":412,"type":22},{"name":709,"class":40},"Sohag University"]