[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"systemic-sclerosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:systemic-sclerosis":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,71,0,25,[9,42,75,108,156,199,231,255,281,316,340,365,392,417,442,467,496,522,546,568,590,614,645,678,698],{"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},"100631162","phase-3-a-study-to-test-whether-nerandomilast-helps-people-with-systemic-sclerosis-100631162",false,"NCT07497087","A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis","A Double-blind, Randomised, Placebo-controlled Trial Evaluating the Efficacy and Safety of Oral Nerandomilast Treatment in Patients With Systemic Sclerosis (SSc)","VERANDA™-SSc","Inclusion criteria:\n\n1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.\n2. Patients must be at least 18 years of age and fulfil the 2013 American College of Rheumatology\u002FEuropean Alliance of Associations for Rheumatology (ACR\u002FEULAR) criteria for SSc.\n3. Patients must be diagnosed with limited cutaneous SSc (lcSSc) or diffuse cutaneous SSc (dcSSc), as defined by LeRoy et al. (1988).\n4. Disease onset (defined by first non-RP \\[Raynaud's phenomenon\\] symptom) must be within 7 years of Visit 1.\n5. Trial participants with dcSSc must have evidence of active disease during screening.\n6. Trial participants with lcSSc must have evidence of active disease during screening. LcSSc patients must be anti-centromere antibody (ACA) negative.\n7. FVC % predicted ≥45% at Visit 1.\n8. Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) % predicted ≥25% corrected for haemoglobin (Hb) at Visit 1.\n9. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control.\n10. Patients may be either untreated or on stable treatment with permitted immunosuppressive\u002Fimmunomodulatory agents and\u002For nintedanib. All treatments must remain stable prior to Visit 2 and during the screening period\n\nExclusion criteria:\n\n1. Active, unstable, or uncontrolled vasculitis within 8 weeks prior to Visit 1 or during the screening period.\n2. Any suicidal behaviour in the past 2 years.\n3. Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months. Further exclusion criteria apply.","ALL","18 Years",{"count":21,"type":22},448,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Nerandomilast is being developed to help people with systemic sclerosis by potentially improving symptoms and slowing disease progression. This study is open to adults who are at least 18 years old and have systemic sclerosis (SSc). People can join the study if they have limited or diffuse cutaneous SSc with disease onset within 7 years of the first non-Raynaud's symptom. The purpose of this study is to find out whether a medicine called nerandomilast helps people with systemic sclerosis. This study also aims to find out how well nerandomilast is tolerated in people with systemic sclerosis.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take the tablets twice a day.\n\nParticipants are in the study for 1 to about 4 years. During this time, they visit the study site regularly and get phone calls from the site staff. During study visits participants regularly have blood samples taken and doctors check changes in skin thickening, lung function, and internal organs, overall health and the safety and tolerability of study treatment in people with SSc. The results are compared between the groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[28],"Systemic Sclerosis","RECRUITING","2026-08-19",{"date":32,"type":33},"2026-08-20","ACTUAL",{"date":35,"type":33},"2026-07-27",{"date":37,"type":22},"2030-03-17",{"name":39,"class":40},"Boehringer Ingelheim","INDUSTRY",246,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100541355","phase-1-reset-ssc-an-open-label-study-to-evaluate-the-safety-and-efficacy-of-caba-201-a-cd19-car-t-cell-therapy-in-subjects-with-systemic-sclerosis-100541355","NCT06328777","RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis","A Phase 1\u002F2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T Cells (CABA-201) in Subjects With Systemic Sclerosis","Inclusion Criteria:\n\n* Age ≥18 and ≤75\n* A clinical diagnosis of SSc, based on the 2013 American College of Rheumatology and European League Against Rheumatism classification criteria.\n* Early active disease\n* Evidence of significant skin, pulmonary, or cardiac involvement\n\nExclusion Criteria:\n\n* Contraindication to leukapheresis\n* History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites\n* Active infection requiring medical intervention at screening visit\n* Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections.\n* Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures\n* Severe lung or cardiac impairment\n* Previous CAR T cell therapy\n* Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","75 Years",{"count":51,"type":22},37,[53,25],"PHASE2","RESET-SSc: A Phase 1\u002F2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T cell therapy, in Subjects with Systemic Sclerosis",[28,56,57],"Scleroderma","Interstitial Lung Diseases",[59,60,61,62,63,64],"CABA-201","autoimmune disease","anti-CD19 CAR-T therapy","systemic sclerosis","scleroderma","Interstitial lung disease","2026-08-14",{"date":67,"type":33},"2026-08-17",{"date":69,"type":33},"2024-07-02",{"date":71,"type":22},"2029-07",{"name":73,"class":40},"Cabaletta Bio",10,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":107},"100334119","phase-2-autologous-stem-cell-transplantation-in-patients-with-systemic-sclerosis-100334119","NCT03630211","Autologous Stem Cell Transplantation in Patients With Systemic Sclerosis","Autologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Patients With Treatment Resistant Systemic Sclerosis (SSc)","SSc","Cohort 1: Children, Adolescents and Young Adults (Cohort 1)\n\nInclusion:\n\nIndividuals must meet all the following criteria to be eligible for this study.\n\n1. Patient, parent, or legal guardian must have given written informed consent. For patients ≥ 168 years of age who are developmentally able, assent or affirmation will be obtained.\n2. Age 8-24, inclusive, at time of consent.\n3. Diagnosed with Systemic Sclerosis (SSc) at the age of ≤19.\n4. Failure to respond, specifically no improvement or progression of disease, to at least 2 disease-modifying antirheumatic drugs (DMARDS) within 12 months of consent with any of the following conditions:\n\n   1. Progression of skin thickening over the past 6 months or Modified Rodnan skin score (mRSS) ≥ 20\n   2. Progression of ILD within 18 months prior to consent. Progression to be determined by either of the following:\n\n      * CT scan showing increased ground glass opacities or reticulations OR\n      * Pulmonary function testing (PFTs) showing a decrease in FVC% or DLCO% predicted value of ≥10%.\n   3. Myositis - CPK \\> 2x upper limit of normal or MRI consistent with myositis\n   4. Childhood Myositis Assessment Score \\\u003C 30\n   5. Arthritis\n   6. Digital tip ulcerations\n5. Cardiology clearance to undergo stem cell transplantation (documented in subject's medical chart)\n6. Negative for human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, all confirmed by PCR testing.\n7. Negative pregnancy test for females. who have reached menarche.\n\n87\\. All females of childbearing potential and sexually active males must agree to use an FDA approved method of birth control for up to 24 months after BMT or for as long as they are taking any medication that may harm a pregnancy, an unborn child or may cause a birth defect.\n\nExclusion:\n\nIndividuals who meet any of these criteria are not eligible for this study.\n\n1. FVC \\\u003C35%, determined by pulmonary function tests for those able to complete spirometry adequately (per investigator's determination)\n2. O2 sat \\\u003C92% at rest in room air\n3. Estimated CrCl \\\u003C40 mL\u002Fmin,using Cockcroft-Gault formula based on actual body weight.\n4. Active, untreated SSc renal crisis at the time of consent.\n5. ALT \\> 4x upper limit of normal.\n6. Active, uncontrolled infection that would be a contraindication to safe use of high-dose immunosuppressive therapy or cyclophosphamide.\n7. Hematologic abnormalities as defined by any of the following peripheral blood counts:\n\n   1. ANC \\\u003C 1500 cell\u002FµL.\n   2. Platelets \\\u003C 100,000 cells\u002F µL.\n   3. Hemoglobin \\\u003C 9.0 g\u002FdL.\n8. Malignancy within 2 years prior to enrollment, excluding adequately treated squamous cell cancer, basal cell carcinoma or carcinoma in situ. Treatment should have been completed with cure\u002Fremission status documented for at least 2 years.\n9. Past or current medical problems or findings from medical history, physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.\n\nCohort 2 for Adults\n\nInclusion:\n\nIndividuals must meet all the following criteria to be eligible for this study.\n\n1. Patient, parent, or legal guardian must have given written informed consent. For patients ≥ 16 years of age who are developmentally able, assent or affirmation will be obtained.\n2. Age 1618-705560, inclusive, at time of consent. Patients up to age 24, diagnosed with SSc at age ≤ 19, will be included in Cohort 1 and evaluated according to the Pediatric and Young Adult criteria listed in sections 3.1.1 and 3.1.2.\n3. Diagnosed with Systemic Sclerosis (SSc), according to the 2013 ACR\u002FEULAR criteria (van den Hoogen et al., 2013).\n4. All patients must meet either the following skin or ILD criteria. Disease duration is defined as time from first non-Raynaud symptom.\n\n   Skin Criteria: Diffuse SSc, defined by presence of proximal skin thickening and:\n\n   A. If disease duration is of \\\u003C2 years, patients must have a calculated mortality risk prediction score which places them in the intermediate or high- risk category (Domsic et al., 2016). Refer to Appendix 5 for calculation criteria.\n\n   B. If disease duration is of \\>2 years, patients must have evidence of active cutaneous disease based upon 1) a worsening Modified Rodnan Skin Score (MRSS) in the preceding three months or 2) the presence of palpable tendon friction rubs.\n\n   ILD Criteria:\n\n   A. The presence of recognized fibrosis on imaging of \\\u003C2 years AND either \\> 10% of lung involvement by CT scan or FVC% pred \\\u003C80% or B. Fibrosis on imaging of any duration with a decline in FVC% pred of ≥10% over the preceding 12-18 months.\n5. Negative for human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, all confirmed by PCR testing.\n6. Negative pregnancy test for females.\n7. All females of childbearing potential and sexually active males must agree to use an FDA approved method of birth control for up to 24 months after BMT or for as long as they are taking any medication that may harm a pregnancy, an unborn child or may cause a birth defect.\n\nExclusion Criteria Individuals who meet any of these criteria are not eligible for this study.\n\n1. Moderate to severe cardiac involvement defined by any of the following:\n\n   1. New York Heart Association classification of heart failure ≥3.\n   2. Left ventricular ejection fraction (LVEF) \\\u003C50% as determined by cardiac MRI.\n   3. Significant pulmonary hypertension, for subjects ≥ 18 years of age, defined as mean PASP ≥30 mmHg determined by right heart catheterization, or for subjects ≤ 17 years of age, defined as mean PASP \\>45 mmHg, determined by echocardiogram.\n   4. Atrial tachycardia, atrial fibrillation or atrial flutter of ≥1-minute duration, determined by electrocardiogram (EKG) or, cardiac event monitor and\u002For implanted loop recorder (if applicable), or on anti-arrhythmic therapy for the arrhythmias listed above.\n   5. Ventricular tachycardia of ≥6 beats at rate of ≥100 beats per minute, determined by EKG or, cardiac event monitor and\u002For implanted loop recorder (if applicable), or on an anti-arrhythmic therapy for any ventricular arrhythmia.\n   6. Left bundle branch block, bifascicular heart block, Mobitz 2 heart block, complete heart block or infarction pattern as determined by EKG or, cardiac event monitor and\u002For implanted loop recorder\n   7. Presence of pacemaker or implantable cardioverter defibrillator.\n2. Moderate to severe pulmonary involvement defined by any of the following:\n\n   1. Hemoglobin-corrected DLCO \\\u003C45%, determined by pulmonary function tests.\n   2. FVC \\\u003C45%, determined by pulmonary function tests.\n   3. pO2 \\\u003C70 mmHg, determined by an arterial blood gas (not applicable for subjects ≤17 years of age).\n   4. pCO2 ≥45 without supplemental O2 determined by an arterial blood gas (not applicable for subjects ≤17 years of age).\n   5. O2 sat \\\u003C92% at rest without supplemental O2, determined by an arterial blood gas (not applicable for subjects ≤17 years of age).\n   6. Six-minute walk (6MW) results \\\u003C400 feet.\n3. Steroid therapy defined by either of the following:\n\n   1. Subjects who received \\> 10 mg\u002Fday prednisone or equivalent within 30 days prior to start of conditioning regimen on Day -21.\n   2. Subjects who have been treated for concurrent illnesses (eg, asthma) with the equivalent of prednisone 1 mg\u002Fkg\u002Fday or its equivalent for \\> 5 days on \\> 2 occasions during the previous 12 months (prior to conditioning) or \\> 1 occasion in the prior 6 months (prior to conditioning).\n4. Estimated CrCl \\\u003C40 mL\u002Fmin,using Cockcroft-Gault formula based on actual body weight.\n5. Serum creatinine \\>2.0 mg\u002FdL.\n6. Active, untreated SSc renal crisis at the time of consent.\n7. Dependence on nutritional supplementation\u002Fhyperalimentation.\n8. Active gastric antral vascular ectasia (GAVE), defined by a decrease in hemoglobin greater than 1 g\u002FdL in the preceding 60 days, attributed to GAVE.\n9. Active hepatitis defined by any of the following:\n\n   1. AST \\> 2x upper limit of normal.\n   2. ALT \\> 2x upper limit of normal.\n   3. Bilirubin \\>2x upper limit of normal.\n10. Evidence of moderate to severe periportal fibrosis, determined by liver biopsy, if applicable.\n11. Active, uncontrolled infection that would be a contraindication to safe use of high-dose immunosuppressive therapy or cyclophosphamide.\n12. Hematologic abnormalities as defined by any of the following peripheral blood counts:\n\n    1. ANC \\\u003C 1500 cell\u002FµL.\n    2. Platelets \\\u003C 100,000 cells\u002F µL.\n    3. Hemoglobin \\\u003C 9.0 g\u002FdL.\n13. Evidence of myelodysplasia (MDS), confirmed by bone marrow aspirate, if applicable.\n14. Malignancy within 2 years prior to enrollment, excluding adequately treated squamous cell cancer, basal cell carcinoma or carcinoma in situ. Treatment should have been completed with cure\u002Fremission status documented for at least 2 years, with the exception of hormonal therapy for breast cancer.\n15. Females who are pregnant or who are lactating.\n16. Tobacco use, by subject admission, within previous 4 weeks of time of consent.\n17. History of sensitivity to murine proteins or E. coli proteins.\n18. Known history of substance abuse, determined by medical record or subject admission, within 6 months of time of consent.\n19. Patient with systemic reaction to anti-thymocyte globulin or any other equine gamma globulin preparation\n20. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.","8 Years","60 Years",{"count":86,"type":22},8,[53],"The purpose of this study is to determine whether a regimen of high-dose immunoablative therapy will demonstrate safety that is consistent or improved with other published regimens in SSc patients, while maintaining a treatment effect.",[28,90,91,92],"Diffuse Sclerosis Systemic","Interstitial Lung Disease","Pulmonary Hypertension",[94,28,56,91,95,92,96,97],"Stem Cell Transplantation","ILD (Interstitial Lung Disease)","BMT ( bone marrow transplantation)","Autologous","2026-08-12",{"date":65,"type":33},{"date":101,"type":33},"2018-07-31",{"date":103,"type":22},"2028-08-01",{"name":105,"class":106},"Paul Szabolcs","OTHER",3,{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":119,"conditions":120,"keywords":135,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":4},"100649638","inflammatory-disease-biobank-for-immunophenotyping-and-cardiovascular-research-100649638","NCT07737470","Inflammatory Disease Biobank for Immunophenotyping and Cardiovascular Research","INFLAMMATORY AND IMMUNE-MEDIATED DISEASES BIOBANKING FOR IMMUNOPHENOTYPING AND CARDIOVASCULAR RESEARCH","INFLAME-BANK","Inclusion Criteria:\n\n* Patient enrolled in EACVI-INFLAME study\n* The patient consents\n\nExclusion Criteria:\n\n* Patients with a history of heart transplant\n* Patient unable to provide informed consent\n* Patient under complete or limited guardianship\n* Patient affected by pre-existing immunodeficiency, including HIV (not including immunosuppressive treatment)",{"count":117,"type":22},300,"OBSERVATIONAL","INFLAME-BANK is a French multicenter prospective observational ancillary study of the international EACVI-INFLAME project. It aims to establish a biobank and perform immunophenotyping and proteomic analyses in patients with suspected inflammatory cardiovascular diseases and autoimmune rheumatic diseases (ICARDs).\n\nThe primary objective is to identify immune biomarkers associated with cardiovascular prognosis and develop disease-specific prognostic scores to predict 1-year major adverse cardiovascular events (MACE). Secondary objectives include evaluating the diagnostic and prognostic value of immunoproteomic biomarkers, assessing the role of photon-counting CT (PCCT) imaging, and investigating immune signatures associated with genetic variants in acute myocarditis.\n\nThe study plans to enroll 300 patients from French centers participating in EACVI-INFLAME. Blood samples will be collected during routine clinical care at inclusion, with optional follow-up sampling at 12 months and optional PCCT imaging and genetic analyses depending on each center's participation. Patients will be followed for 12 months to monitor cardiovascular outcomes.\n\nThe expected impact is to improve understanding of the immune mechanisms underlying ICARDs, facilitate earlier diagnosis and risk stratification, identify new therapeutic targets, and ultimately support more personalized management of patients with inflammatory cardiovascular diseases.",[121,122,123,124,125,28,126,127,128,129,130,131,132,133,134],"Pericarditis","Tako-TSUBO Cardiomyopathy","Myocarditis","Inflammatory Cardiomyopathies","Lupus","Antiphospholipid Syndrome","Idiopathic Inflammatory Myopathies","Rheumatoid Arthritis","Spondyloarthritis","ANCA-associated Vasculitis","Takayasu Arteritis","Giant Cell Arteritis","Behçet Disease","Still Disease",[136,137,138,139,140,141,142,143,144,145],"Inflammatory cardiovascular diseases (ICARDs)","Autoimmune rheumatic diseases","Cardiovascular involvement","Immunophenotyping","roteomics","Biomarkers","Biobanking","Major adverse cardiovascular events (MACE)","Cardiovascular imaging","Prospective observational study","NOT_YET_RECRUITING","2026-08-06",{"date":149,"type":33},"2026-08-10",{"date":151,"type":22},"2026-09-01",{"date":153,"type":22},"2028-10-01",{"name":155,"class":106},"Assistance Publique - Hôpitaux de Paris",{"id":157,"slug":158,"hasResults":12,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":163,"enrollmentInfo":164,"targetDuration":4,"studyType":23,"phases":166,"briefSummary":168,"conditions":169,"keywords":176,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":198},"100587219","phase-1-a-safety-and-efficacy-study-evaluating-ctx112-in-adult-subjects-with-refractory-autoimmune-disease-100587219","NCT06925542","A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease","A Phase 1 Dose Evaluation Study of the Safety and Preliminary Efficacy of Anti-CD19 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX112) in Adult Subjects With Refractory Autoimmune Disease","Key Inclusion Criteria:\n\n1. Age ≥18 years and \\\u003C 70 years of age.\n2. Subjects must voluntarily sign a written informed consent and be willing and able to comply with all study requirements.\n3. Adequate hematologic, renal, liver, cardiac and pulmonary organ function.\n4. Subjects must agree to use acceptable methods of contraception.\n5. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, contraceptive guidelines, and other study procedures.\n6. Diagnosis of systemic lupus erythematosus (SLE), systemic sclerosis (SSc) or idiopathic inflammatory myopathy (IIM).\n\nFor systemic lupus erythematosus (SLE) subjects:\n\n\\- Diagnosis of SLE by a board-certified rheumatologist that conforms with 2019 ACR\u002FEULAR criteria. For lupus nephritis subjects, active, biopsy-proven proliferative lupus nephritis Class III or IV, either with or without the presence of Class V, and appropriate National Institutes of Health index activity score using the 2018 International Society of Nephrology\u002FRenal Pathology Society criteria.\n\nFor Systemic Sclerosis (SSc) subjects:\n\n\\- Diagnosis of diffuse cutaneous systemic sclerosis (dcSSC) or SSc-ILD that conforms with 2013 ACR\u002FEULAR criteria. Subjects should meet active skin or lung disease criteria.\n\nFor Idiopathic Inflammatory Myopathy (IIM) subjects:\n\n\\- Diagnosis with dermatomyositis (DM), polymyositis (PM) or myositis as part of rheumatologic overlap syndrome, antisynthetase (ASyS), or immune-mediated necrotizing myopathy (IMNM) that conforms with 2017 ACR\u002FEULAR criteria for inflammatory myopathies. Subjects must meet moderate severe, skin, or lung involvement criteria.\n\nKey Exclusion Criteria:\n\n1. Prior anti-CD19 therapy or any gene therapy\u002Fgenetically modified cell therapy.\n2. Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant.\n3. Severe active or history of central nervous (CNS) involvement.\n4. History of a seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease or any autoimmune disease with CNS involvement other than SLE, SSc or IIM.\n5. Mixed connective tissue disease with no clear predominant disease.\n6. Presence of study disease manifestations or other conditions that are likely to pose increase safety risks and\u002For confound disease assessments, or pose significant risk to those receiving CAR T cell therapy.\n7. History of primary or secondary immunodeficiency.\n8. Presence or history of certain bacterial, viral or fungal infection.\n9. Malignancy in the last 5 years (with the exception of cancers deemed to be low likelihood for recurrence).\n10. Diagnosis of a genetic disorder associated with bone marrow failure or myelodysplastic syndrome.\n11. History or current diagnosis of catastrophic anti-phospholipid syndrome or anti phospholipid syndrome that requires ongoing anticoagulation.\n12. Pregnant or lactating.\n13. Presence or history of disease requiring treatment that is not compatible with the study protocol; presence or history of other conditions that are not compatible with the study protocol.","70 Years",{"count":165,"type":22},80,[167],"PHASE1","This is a single-arm, open-label, multicenter, ascending dose Phase 1 study evaluating the safety and preliminary efficacy of CTX112 in adult subjects with refractory autoimmune diseases, including active systemic lupus erythematosus (SLE), systemic sclerosis (SSc), or idiopathic inflammatory myopathy (IIM).",[170,171,172,28,173,174,175],"SLE (Systemic Lupus)","Lupus Erythematosus, Systemic","Lupus Nephritis","Inflammatory Myopathy, Idiopathic","Myositis","Diffuse Cutaneous Systemic Sclerosis",[177,125,178,172,179,180,181,56,174,182,183,184,185,186,187,81,188],"CAR T","SLE","Allogeneic","CD19","Cell Therapy","Systemic sclerosis","Idiopathic Inflammatory Myopathy","Inflammatory Myopathy","Diffused Cutaneous Systemic Sclerosis","Gene Therapy","Autoimmune","IIM","2026-08-05",{"date":191,"type":33},"2026-08-07",{"date":193,"type":33},"2025-03-10",{"date":195,"type":22},"2031-12-31",{"name":197,"class":40},"CRISPR Therapeutics",14,{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":49,"enrollmentInfo":206,"targetDuration":4,"studyType":23,"phases":208,"briefSummary":209,"conditions":210,"keywords":212,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":230},"100572489","phase-1-a-phase-12-study-of-nkx019-in-subjects-with-immune-mediated-diseases-ntrust-2-100572489","NCT06733935","A Phase 1\u002F2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)","A Phase 1\u002F2 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects With Immune-Mediated Diseases","General Inclusion Criteria:\n\n1. Age ≥18 and ≤75\n2. Signed informed consent form and ability to adhere to the study visit schedule and comply with other protocol requirements\n3. Women of childbearing potential must have negative pregnancy tests at screening and baseline, and agree to abstinence or acceptable birth control from 2 weeks prior to the first dose through 1 year after the last dose\n4. For participants taking corticosteroids, the prednisone (or equivalent) dose must be ≤20 mg\u002Fday at 2 weeks prior to Screening and stable for ≥ 14 days before start of Screening\n5. For participants on immunosuppressives or immunomodulators (other than corticosteroids), all doses must be stable for ≥ 4 weeks prior to Screening\n6. eGFR as calculated by the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation of ≥45 mL\u002Fmin\u002F1.73 m2 at screening\n\nSSc Inclusion Criteria:\n\n1. Meets the 2013 American College of Rheumatology (ACR)\u002FEuropean Alliance of Associations for Rheumatology (EULAR) classification criteria for SSc\n2. Meet criteria a and\u002For b:\n\n   a. Severe skin involvement defined as mRSS ≥ 30 or active skin disease defined as mRSS ≥ 15 at screening and one or more of the following within the prior 6 months of screening:\n\n   i. An increase in mRSS of ≥ 3 units\n\n   ii. Involvement of 1 new body area with ≥ 2 mRSS units\n\n   iii. 2 new body areas with ≥ 1 mRSS unit\n\n   b. Moderate to severe Interstitial Lung Disease (ILD) defined by evidence of ILD on High-resolution computed tomography (HRCT) and FVC \\\u003C 70% of predicted or DLCO (hemoglobin or alveolar volume corrected) \\\u003C 70% of predicted or ILD on HRCT and progressive ILD meeting at least 2 of the following 3 criteria within the prior 6 months of screening:\n\n   i. Worsening respiratory symptoms\n\n   ii. Evidence of progression on HRCT, or\n\n   iii. Evidence of absolute decline in FVC ≥ 5%\n3. 10 years or less since the first non-Raynaud's sign or symptom\n4. Inadequate response or intolerance to at least one treatment, including cyclophosphamide, methotrexate, MMF\u002Fmycophenolic acid, nintedanib, rituximab, or tocilizumab\n\nIIM Inclusion Criteria:\n\n1. Diagnosis for IIM as per 2017 ACR\u002FEULAR Classification Criteria\n2. One positive myositis antibody\n3. Activity defined as manual muscle testing (MMT-8) score \\\u003C136\u002F150\n4. Creatinine kinase or aldolase ≥ 1.5 x ULN and Clinician Global Assessment ≥ 2 cm with at least one of the following:\n\n   1. Evidence on magnetic resonance imaging (MRI) of active myositis within the last 6 months\n   2. Electromyography (EMG) with active myositis within the last 6 months\n   3. Muscle Biopsy of active myositis within last 6 months\n   4. Global extramuscular activity score ≥2 cm per Clinician global assessment (CGA) using a visual analog scale (VAS) (0-100 mm)\n\n   Note: Participants with DM or ASyS may be eligible despite CK or aldolase \\\u003C1.5 × ULN, provided they have a Clinician Global Assessment ≥2 cm and meet at least one of criteria (a)-(d) above OR have a CDASI score of ≥20.\n5. Inadequate response to treatment defined as ≥ 3 months failure (or intolerance) to at least 2 immunosuppressive therapies (including glucocorticoids)\n\nAAV:\n\n1. Meets the 2022 ACR\u002FEULAR classification criteria for Granulomatosis with Polyangiitis (GPA) (Robson 2022) or Microscopic Polyangiitis (MPA) (Suppiah 2022)\n2. Relapsed or refractory AAV despite repeated treatment with immunosuppressive agents or requiring prolonged and\u002For repeated courses of unacceptable doses of glucocorticoids to maintain disease control\n3. Positive test for anti-proteinase-3 (PR3-ANCA) or anti-myeloperoxidase (MPO-ANCA) at screening\n4. Have at least one \"major\" item, or at least 3 other items, or at least 2 renal items on the BVAS version 3\n\nRA Inclusion Criteria:\n\n1. Documented diagnosis of RA, meeting the 2010 ACR\u002FEULAR classification criteria\n2. Rheumatoid Factor (RF) or Anti-Citrullinated Protein Antibody (ACPA) positive\n3. CRP \\>3 mg\u002FL\n4. Inadequate response, defined as failure to achieve a clinically meaningful improvement (eg, ACR50 response or DAS28-low disease activity \\[ie, DAS28 \\>3.2\\]) after at least 12 weeks of therapy with the following:\n\n   1. At least 1 conventional synthetic DMARD (csDMARD) (eg, methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) AND\n   2. Either of the following:\n\n   i. At least 2 biologic (b) DMARDs (eg, TNF inhibitors, abatacept, anti-IL-6 or anti-IL-6R, rituximab) with distinct mechanisms of action (MoAs)\n\n   OR\n\n   ii. At least 1 bDMARD and at least 1 targeted synthetic DMARD (tsDMARD) (eg, JAK inhibitor)\n\n   AND\n\n   c. Have failed no more than 3 biologics or tsDMARDs with unique mechanisms of action\n5. Minimum of 6 swollen joint counts (SJCs) and 6 tender joint counts (TJCs) according to joint assessment\n\nGeneral Exclusion Criteria:\n\n1. eGFR \\\u003C 45 ml\u002Fmin\u002F1.73m2\n2. Currently requiring renal dialysis or expected to require dialysis during the study period\n3. Previous solid organ or hematopoietic cell transplant or planned transplant within study treatment period\n4. Congenital or acquired immunodeficiency resulting in severe infection or those receiving chronic immunoglobulin replacement therapy\n5. Liver disease or dysfunction, including cirrhosis and\u002For bilirubin ≥ 3 times the upper limit of normal\n6. Pulmonary comorbidity including chronic obstructive pulmonary disease or asthma requiring daily oral steroids, resting hypoxemia (\\\u003C92% oxygen saturation via pulse oximetry) on room air, or significant smoking history (i.e. \\>10 pack\u002Fyear) with active pulmonary disease\n7. Participants with ILD with any of the following:\n\n   1. Requires supplemental oxygen therapy\n   2. FVC \\\u003C45% of predicted\n   3. Diffusing capacity of the lung (DLCO) corrected for alveolar volume (AV) or Hemoglobin (Hgb) ≤ 40% of predicted at screening (per Investigator or Sponsor judgement)\n\n   i. If the participant has a historical FVC value within the last year that exceeds the 45% threshold, discuss with the Medical Monitor should the Screening FVC be \\\u003C45% predicted\n8. Bone marrow insufficiency unrelated to active underlying autoimmune disease with white blood cell count \\\u003C 3,000\u002Fmm\\^3; hemoglobin levels ≤ 9 g\u002FdL; absolute neutrophil count (ANC) ≤ 1500\u002Fmm\\^3; platelet count ≤ 100,000\u002Fmm\\^3, and blood transfusion within 60 days prior to LD\n9. Major cardiac disease, abnormalities, or interventions as defined by, but not limited to:\n\n   1. Uncontrolled angina or unstable life-threatening arrhythmias\n   2. History of myocardial infarction within 12 weeks prior to the first dose of NKX019\n   3. Any prior coronary artery bypass graft surgery\n   4. ≥ Class III New York Heart Association (NYHA) congestive heart failure (CHF), significantly decreased ejection fraction (EF ≤ 40%), or severe cardiac insufficiency\n   5. Prolongation of the QT interval corrected for heart rate (QTc) (Fridericia) interval of \\> 480 msec\n   6. Peripheral artery bypass graft surgery, pulmonary embolism, or other ≥ Grade 2 thrombotic or embolic events within 12 weeks prior to the first dose of NKX019\n10. Active bleeding disorders\n11. Any overlapping autoimmune condition for which the condition or the treatment of the condition may affect the study assessments or outcomes (eg, anti-GBM antibody glomerulonephritis or any condition for additional immunosuppression is indicated); clinically significant conditions that could cause a secondary nephropathy (eg, infections, liver disease, tumors or drugs); or kidney biopsy-confirmed significant renal disease other than disease under study (eg, diabetic nephropathy, hypertensive nephropathy). Overlapping conditions for which the condition or treatment is not expected to affect assessments or outcomes (eg, Sjögren's syndrome, rheumatoid arthritis) are not excluded\n12. Pregnancy, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions\n13. Current infection requiring active systemic anti-infective therapy or recent acute infection requiring systemic therapy within 30 days of planned LD\n14. History of positive HIV test at screening, Hepatitis B or C positive at screening, active tuberculosis (TB) or latent TB requiring suppressive therapy\n15. Major surgery within 28 days prior to the first dose of NKX019 or any surgery from which the participant has not recovered or has ongoing complications\n16. Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision. Participants with cervical dysplasia that is cervical intraepithelial neoplasia but have been treated with conization or loop electrosurgical excision procedure and have had a normal repeat Papanicolaou test are allowed\n17. Prior cellular therapy including mesenchymal, CAR-T or CAR-NK cells\n18. Central nervous system (CNS) comorbidity or any autoimmune disease with CNS involvement within 90 days prior to the first dose of NKX019 as well as evidence of CNS related autoimmune manifestations within 1 year prior to screening\n\nSSc Exclusion Criteria:\n\n1. Moderate-to-severe Pulmonary arterial hypertension (PAH) on right heart catheterization requiring PAH specific treatment. Those participants with mild PAH (as defined by the 2022 ECS\u002FERS Guidelines, \\[Humbert 2023\\]) well controlled on therapy can be enrolled\n2. Gastrointestinal (GI) dysmotility requiring total parenteral nutrition (TPN)\n3. Renal crisis or Pericardial tamponade within 6 months prior to enrollment\n4. Current gangrene of a digit\n\nIIM Exclusion Criteria:\n\n1. Evidence of severe chronic proximal muscle involvement of upper or lower extremities, based on Magnetic Resonance Imaging (MRI) defined as:\n\n   1. ≥15% fibro-fatty replacement in core muscle groups (including gluteus and vastus musculature), and\u002For\n   2. ≥15% muscle atrophy in these regions Participants will also be excluded if the combined extent of fibro-fatty replacement and muscle atrophy exceeds 30% in aggregate\n2. MMT-8 of ≤ 80\n3. Findings of muscular inflammation or myopathy due to another cause, such as inclusion body myositis, cancer-associated myositis (myositis diagnosed within 2 years of cancer), amyloid myopathy, muscular dystrophy, metabolic myopathies, or myositis in the context of significant overlap with another systemic IIM rheumatologic disease (overlap myositis), except with Sjögren's syndrome\n4. Generalized severe musculoskeletal or neuro-muscular conditions other than IIM\n5. Immune-mediated necrotizing myopathy\n\nAAV Exclusion Criteria:\n\n1. Alveolar hemorrhage requiring invasive pulmonary ventilation support\n2. Required dialysis or plasma exchange within 12 weeks prior to screening\n3. Any other known disease that may interfere with the assessments including eosinophilic GPA (Churg-Strauss), anti-glomerular basement membrane, systemic lupus erythematosus, IgA vasculitis (Henoch Schönlein), rheumatoid vasculitis, or cryoglobulinemic vasculitis",{"count":207,"type":22},240,[167,53],"This is a Phase 1\u002F2, open-label, multi-center, multi-cohort, non-randomized dose escalation and dose expansion basket study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in participants with autoimmune diseases.",[28,127,211,128],"Antineutrophil Cytoplasmic Antibody-Associated Vasculitis",[180,213,179,214,215,216,217,181,218,219,56,174,220,28,127,221,222,128],"CAR","NKX019","Natural Killer Cells","Interleukin-15","IL-15","Immunotherapy","Adoptive cell therapy","AAV","Antineutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis","Ntrust-2",{"date":191,"type":33},{"date":225,"type":33},"2024-11-04",{"date":227,"type":22},"2028-10",{"name":229,"class":40},"Nkarta, Inc.",18,{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":18,"minAge":239,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":23,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":254},"100618741","phase-3-a-study-to-compare-the-efficacy-and-safety-of-bms-986353-zolacabtagene--autoleucel--zola-cel-cd19-car-t-cells-versus-standard-of-care-in-participants-with-active-systemic-sclerosis-100618741","NCT07335562","A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel \u002F Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis","A Phase 3, Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of BMS-986353, CD19-targeted NEX-T CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis (Breakfree-SSc)","Breakfree-SSc","Inclusion Criteria\n\n\\- Participants must fulfill the 2013 American College of Rheumatology (ACR) \u002F European League Against Rheumatism (EULAR) classification criteria for Systemic Sclerosis (SSc), and additionally have the following:.\n\ni) Positive Antinuclear Antibodies (ANA) with nucleolar pattern and\u002For anti-Topoisomerase I (anti-Scl-70) antibodies.\n\nii) Confirmation of Interstitial Lung Disease (ILD) on centrally read High-Resolution Computed Tomography (HRCT) with ≥ 10% total lung involvement, with at least one of the following attributed to active SSc:.\n\nA. Arthritis.\n\nB. Myositis.\n\nC. Carditis.\n\nD. Progressive skin disease.\n\nE. Elevated inflammatory markers.\n\n\\- Participants must have a non-response or intolerance despite ≥ 6 months of treatment with at least one immunomodulatory drug. Non-response is defined as a patient, who in the opinion of the investigator, is not adequately controlled\u002Ftreated and requires treatment escalation.\n\nExclusion Criteria\n\n* Participants must not have a requirement for supplemental oxygen therapy and\u002For Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) ≤ 40% (Hemoglobin (Hgb) corrected) at screening.\n* Participants must not have moderate to severe Pulmonary Arterial Hypertension (PAH) requiring PAH-specific combination treatment\n* Participants must not have pulmonary comorbidity including chronic obstructive pulmonary disease or asthma requiring daily oral corticosteroids, cigarette smoking (including e-cigarettes) within 3 months before screening or unwilling to avoid smoking throughout the study, and\u002For clinically significant abnormalities on HRCT not attributable to SSc assessed by the central reader at screening.\n* Participants must not have gastrointestinal (GI) dysmotility requiring Total Parenteral Nutrition (TPN).\n* Participants must not have current gangrene of a digit\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","16 Years",{"count":241,"type":22},92,[25],"The purpose of this study is to compare the efficacy and safety of BMS-986353 versus standard of care in participants with active Systemic Sclerosis",[28],"2026-07-31",{"date":247,"type":33},"2026-08-03",{"date":249,"type":22},"2026-08-29",{"date":251,"type":22},"2030-11-11",{"name":253,"class":40},"Juno Therapeutics, Inc., a Bristol-Myers Squibb Company",56,{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":262,"sex":18,"minAge":19,"maxAge":49,"enrollmentInfo":263,"targetDuration":4,"studyType":23,"phases":265,"briefSummary":266,"conditions":267,"keywords":270,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":274,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":278,"locationsCount":280},"100614838","phase-1-a-phase-1-open-label-study-to-evaluate-safety-in-healthy-participants-and-participants-with-autoimmune-diseases-100614838","NCT07284797","A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune Diseases","A Phase 1, First-in-Human, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of XmAb657 in Healthy Participants and in Participants With Autoimmune Diseases","Inclusion Criteria:\n\nHealthy participants - Adult participants in good health\n\nIdiopathic inflammatory myopathy (IIM) participants - Adult participants that meet the 2017 European Alliance of Association Rheumatology (EULAR)\u002FAmerican College of Rheumatology (ACR) Classification Criterion for IIM\n\nSystemic sclerosis (SSc) participants - Adult participants that meet the 2013 ACR\u002FEULAR Classification Criteria for SSc\n\nSjogren's Disease participants that meet the 2016 ACR\u002FEULAR Classification Criteria for Primary Sjogren's Syndrome\n\nAll participants - Use of highly effective methods of contraception\n\nExclusion Criteria:\n\n* Major surgery within 12 weeks prior to dosing or planned within the study\n* Recurrent infections or active clinically significant infection\n* Active or untreated latent tuberculosis\n* Cancer or history of cancer or lymphoproliferative disease within the previous 5 years\n* Uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease\n\nNote: Additional, more specific inclusion\u002Fexclusion criteria are defined in the protocol.",true,{"count":264,"type":22},60,[167],"The purpose of this study is to determine the safety and tolerability of XmAb657 in healthy participants and participants with autoimmune diseases. Participants will be given XmAb657 subcutaneously (SC) by injection under the skin.",[268,127,28,269],"Healthy","Sjögren's Disease",[271,174,56,272,188,273,81],"Myopathy","Autoimmune Diseases","SjD",{"date":247,"type":33},{"date":276,"type":33},"2026-02-24",{"date":227,"type":22},{"name":279,"class":40},"Xencor, Inc.",1,{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":289,"enrollmentInfo":290,"targetDuration":4,"studyType":23,"phases":292,"briefSummary":293,"conditions":294,"keywords":296,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":315},"100599485","phase-1-a-study-to-investigate-the-safety-and-preliminary-efficacy-of-allo-329-an-allogeneic-car-t-cell-therapy-in-adults-with-autoimmune-disease-100599485","NCT07085104","A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease","A Phase 1 Study Evaluating the Safety and Preliminary Efficacy of ALLO-329, a Dual Anti-CD19\u002FAnti-CD70 Allogeneic CAR T Cell Product in Autoimmune Disease","RESOLUTION","Inclusion Criteria:\n\n1. Adults ≥ 18 to \\\u003C 75 years of age.\n2. Adequate hematological function and liver, cardiac, and pulmonary function.\n3. A highly sensitive urine pregnancy test or serum pregnancy test (for females of childbearing potential) negative at screening. All participants of childbearing potential must be willing to use a highly effective method of contraception for at least 12 months for females (6 months for males) after LD chemotherapy or ALLO-329 administration, whichever is later.\n4. Signed and dated informed consent form.\n5. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures.\n6. Confirmed active disease (SLE, IIM, or SSc) as defined by the appropriate classification criteria for each respective disease, clinical evidence, and\u002For laboratory testing.\n7. Disease activity as above despite prior treatment with standard of care therapy including at least one immunosuppressive agent for at least 3 months.\n\nExclusion Criteria:\n\n1. Participants with active systemic bacterial, fungal, or viral infection requiring systemic treatment or a clinically significant active, opportunistic, chronic or recurrent infection.\n2. Any active malignancy within 5 years prior to enrollment, except for adequately treated localized basal cell or squamous cell skin cancer, carcinoma in situ or low risk prostate cancer (Gleason score ≤ 6) under observation. Prior treatment of cancer with curative intent which in the opinion of the treating oncologist has less than a 10% chance of recurrence in the next 10 years can be allowed after discussion with the sponsor.\n3. Prior treatment with CD19 or CD70 targeted therapy or any prior engineered cell therapy (e.g., CAR T therapy), except prior treatment with ALLO-329 in this study.\n4. Clinically significant or unstable or uncontrolled acute or chronic disease (e.g., hypothyroidism and diabetes).\n5. Symptomatic cardiac or vascular disease requiring medical intervention within 6 months prior to screening, hemodynamically symptomatic pericardial effusion, or symptomatic electrocardiogram abnormality requiring medical intervention.\n6. Child-Pugh Class B or C cirrhosis.\n7. Symptomatic airway disease requiring medical intervention, pleural effusion ≥ Grade 2, or history of pulmonary embolism requiring anticoagulant therapy within 6 months of ALLO-329 dosing.\n8. Participants known to be refractory to platelet or red blood cell transfusions or who will refuse indicated transfusion support to manage cell counts following treatment.\n9. Any form of primary, inherited immunodeficiency.\n10. Unwilling to participate in an extended safety monitoring period.\n11. For participants with SLE: History or active disease involving CNS within the last 6 months or SLE that is drug-induced. For those with lupus nephritis, history of dialysis within 12 months prior to signing the informed consent form or expected need for renal replacement therapy within the next 12 months after dosing, or National Institutes of Health (NIH) chronicity score of 3+ in any of the following domains: glomerular sclerosis, glomerular fibrous crescents, tubular atrophy, and\u002For interstitial fibrosis.\n12. Participants with IIM: A myositis other than specified classification per exclusion criteria, non-reversible, unrelated or weakness not amenable to assessment, or dermatomyositis with presence of anti-TIF1 gamma antibody.\n13. Participants with SSc: Pulmonary arterial hypertension requiring treatment, rapidly progressive or severe SSc gastrointestinal involvement, or prior scleroderma renal crisis.","74 Years",{"count":291,"type":22},66,[167],"This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary efficacy of ALLO-329 in adults with autoimmune diseases: systemic lupus erythematosus (SLE) with and without renal involvement, idiopathic inflammatory myopathy (IIM), and systemic sclerosis (SSc).The purpose of this trial is to evaluate the safety and tolerability of ALLO-329, an allogeneic anti-CD19, anti-CD70 dual chimeric antigen receptor (CAR) T cell therapy, in adults with autoimmune disorders, provide initial evidence of biological activity and clinical response to the treatment and determine the recommended Phase 2 regimen (RP2R).",[295,183,28],"Systemic Lupus Erythematosus (With and Without Nephritis)",[297,178,298,299,300,188,174,301,302,182,56,81,303,177,304,180,305,306],"Systemic lupus erythematosus","Lupus nephritis","LN","Idiopathic inflammatory myopathy","Dermatomyositis","Anti-synthetase syndrome","Autoimmune disease","Allogeneic CAR T","CD70","AlloCAR T","2026-07-29",{"date":245,"type":33},{"date":310,"type":33},"2025-11-13",{"date":312,"type":22},"2032-10",{"name":314,"class":40},"Allogene Therapeutics",15,{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":18,"minAge":323,"maxAge":324,"enrollmentInfo":325,"targetDuration":4,"studyType":23,"phases":327,"briefSummary":328,"conditions":329,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":338,"locationsCount":280},"100588903","phase-1-cd19-bcma-cart-cell-therapy-for-refractory-sle-ln-ssc-and-pss-pah-100588903","NCT06947460","CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH","CD19-BCMA CART Cell Therapy for Refractory Systemic Lupus Erythematosus Nephritis (SLE-LN), Systemic Sclerosis (SSc), and Primary Sjogren Syndrome Combined With Pulmonary Artery Hypertension (pSS-PAH): a Single-center, Open, Non-randomized, Single-arm Clinical Study","Inclusion Criteria 1. Refractory Lupus Nephritis（LN）: Patients who meet all the following requirements can be enrolled in the group.\n\nDefinition: Failure to achieve induction remission after 3 to 6 months of treatment with at least one immunosuppressive agent (including glucocorticoids, cyclophosphamide \\[CTX\\], tacrolimus, mycophenolate mofetil, and cyclosporine), accompanied by no reduction (or worsening) in proteinuria or persistent positive autoantibodies.\n\nDiagnostic criteria : According to the 2019 American College of Rheumatology (ACR) criteria, and confirmed by renal biopsy in accordance with the 2018 International Society of Nephrology (ISN)\u002FRenal Pathology Society (RPS) criteria (Appendix 3), were diagnosed with active, proliferative lupus nephritis (LN), including Class III or IV \\[excluding Class III (C), IV-S (C), and IV-G (C)\\], or combined Class III\u002FIV with Class V.\n\n1. Male or female, aged 10-65 years;\n2. Meeting the 2019 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) Classification Criteria for Systemic Lupus Erythematosus (Appendix 4);\n3. The ANA result is positive which means ANA titer≥ 1:80 (based on the equivalent detection results by Hep-2 immunofluorescence assay or enzyme immune assay), and\u002For according to the detection results from center laboratory, during the screening visit,the anti dsDNA serum antibody test is positive (based on ELISA assay, ≥30 IU\u002FmL);\n4. B cell CD19+ expression, and stop using immunosuppressant more than one week.\n5. The lymphocyte count in the subject's blood routine \\>0.5×109\u002FL, and no contraindications for cell collection;\n6. No serious allergic constitution;\n7. ECOG score: 0-2:\n8. Expected survival ≥90 days:\n\nSubjects and\u002For their guardian can understand and sign the informed consent form.\n\n2\\. SSc: Patients who meet all the following requirements can be enrolled in the group.\n\n1. Patients or their legal representatives sign the informed consent form;\n2. Male or female, aged 18-65 years.\n3. According to the SSc classification criteria proposed by American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR), chose the highest score under the same condition. If the score ≥9, it can be classified SSc. (Appendix 5)\n4. Satisfy a sufficient condition: the skin on the fingers of both hands is thickened and extend to the proximal end of metacarpophalangeal joint;\n5. The lymphocyte count in the subject's blood routine \\>0.5×109\u002FL, and no contraindications for cell collection.\n\n3\\. pSS-PAH: Patients who meet all the following requirements can be enrolled in the group.\n\n1. Patients or their legal representatives sign the informed consent form;\n2. Male or female, aged 18-65 years;\n3. Refractory connective tissue disease (PAH)patients:\n\n   a) Satisfy the 2002 AECG or 2016 ACR\u002F2016 EULAR classification criteria, can be diagnosed as pSS (Appendix 6); b) Confirmed by Right heart catheterization, satisfy the diagnose criteria of PAH: mPAP at rest ≥20mmHg; PAWP≤15mmHg; PVR at rest\\>2WUs.\n4. Low-risk patients whose PAH do not reach the risk stratification. The patients should meet: WHO cardiac function grading I-II; 6 minutes walking distance\\>440 m; BNP\\\u003C50ng\u002FL or NT-proBNP\\\u003C300ng\u002FL; RAP\\\u003C8mmHg and CI≥2.5 L·min-1·m-2;\n5. Subjects have received standard treatment in stable dose before first use of study drug, include: Glucocorticoids (prednisone 0-30mg\u002Fday, or other equivalent preparations) ≥4 weeks; Antimalarial drugs, single-agent immunosuppressants (MMF≤1.5g\u002Fday, AZP or 6-MP≤2mg\u002Fkg\u002Fday, MTX≤15mg\u002Fweek, Leflunomide ≤ 20mg\u002Fday) ≥12 weeks, and do not add or change in 24 weeks after drug treatment; Use PAH target drugs \\\u003C3 before drug treatment(PGAs, ETRA,PDE-5 inhibiter, GCCA), and stable at least 4 weeks, and do not add or change in 24 weeks after drug treatment;\n6. After clinician evaluate the disease condition of patients, they will allow using glucocorticoids no more than 10mg or other equivalent dose and stop all immunosuppressants (exclued hydroxychloroquine);\n7. Reproductive-aged female patients with negative blood human chorionic gonadotropin (HCG) test within 7 days before trial pre-conduct treatment; Any child-bearing male and female patients must agree to take effective contraceptive method during the process of study and within at least 1 year after cell infusion. Child-bearing patients refer that he or she has the biological ability to born alive baby and have normal sex life. Female patients without the ability of born: hysterectomy or ovariectomy, or medically confirmed ovarian failure, or medically confirmed postmenopausal (without pathological or biological reason, amenorrhea last for at least 12 months);\n8. Have appropriate organ function, the criteria are as follows:\n\n   a) AST≤3 times upper limit of normal (ULN); b) ALT ≤3 times ULN; c) T-Bil ≤2 times ULN, unless the patient has a record of Gilbert syndrome; Patients with Gilbert syndrome can be enrolled satisfied the condition of Bil≤3 times ULN and DBIl ≤1.5 times ULN; d) Must have the lowest level of lung reserve, oxygen saturation under non-oxygen inhalation state \\>95%; e) The lymphocyte count in the subject's blood routine \\>0.5×109\u002FL, and no contraindications for cell collection.\n\n4.AID Definition: Based on the reliable laboratory test, it is confirmed that one or more definite disease-related antibodies in serum are positive, laboratory results and clinical symptoms have reasonable association. Including systemic lupus erythematosus, sjogren's syndrome, systemic sclerosis, rheumatoid arthritis, connective tissue diseases, overlap syndrome, etc. At the same time exclude other etiology may cause similar symptoms and signs, infections, malignant tumors, metabolic diseases, primary organ failure, etc.\n\n1. Male or female, aged 10-65 years; Patients who do not meet the inclusive criteria of three groups above, meet any one below can be enrolled.\n2. ANA titer\\\u003C1:80 (based on the equivalent detection results by Hep-2 immunofluorescence assay or enzyme immune assay), and\u002For during the screening visit, by the detection results from center laboratory, anti dsDNA serum antibody test is negative (based on ELISA assay, \\\u003C30 IU\u002FmL);\n3. In conventional therapy, occur recurrent infections, leading to intolerance of conventional therapy, but no active infection, serious infection(tuberculosis) currently;\n4. Patients who cannot use drugs anymore, because of bone infarction, osteonecrosis, severe bone pain caused by long term use of drugs.\n5. Patients who cannot use drugs anymore, because of vision changes, retinopathy, fundus hemorrhage caused by long term use of drugs.\n6. Patients who cannot use drugs anymore, because of endocrine-related changes (premature closure of the femoral shaft, severe obesity, diabetes, impact on growth and development, etc.) caused by long term use of drugs.\n7. Severe toxicity of blood system (≥grade3; neutrophil\\\u003C1\\*10\\^9\u002FL,platelet\\\u003C50\\*10\\^9\u002FL,hemoglobin\\\u003C80g\u002FL);\n8. Abnormal liver function (ALT ≥3 times ULN; ALT≥3 times ULN; T-Bil ≥2 times ULN);\n9. After 3 months of regular treatment, there are still have disease progression (eg. urine protein index increased by 3 times);\n10. Previously received CAR-T therapies, there are still have disease progression.\n\nExclusion criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1\\. Refractory Lupus Nephritis (LN):\n\n1. Intracranial hypertension or disorder of consciousness;\n2. Symptomatic heart failure or severe arrhythmia;\n3. Symptoms of severe respiratory failure;\n4. Complicated with other types of malignant tumors;\n5. Diffuse intravascular coagulation;\n6. Suffering from septicemia or other uncontrollable infections;\n7. Patients with uncontrollable diabetes and other endocrine diseases;\n8. Severe mental disorders;\n9. Obvious and active intracranial lesions were detected by cranial magnetic resonance imaging (MRI);\n10. Have received organ transplantation (excluding bone marrow transplant);\n11. Reproductive-aged female patients with positive blood human chorionic gonadotropin (HCG) test;\n12. Positive screening for hepatitis (HBV and HCV included), HIV and syphilis;\n13. The subject is unable to undergo PBMC collection, nor are there cryopreserved PBMCs available for CAR-T cell manufacturing;\n14. eGFR CKD-EPI \\\u003C 30 ml\u002Fmin\u002F1.73m\\^2;\n15. Any active skin disease that may interfere with the assessment of systemic lupus erythematosus (SLE) research, including but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-SLE cutaneous manifestations (e.g., cutaneous vasculopathy, perivascular telangiectasia, sclerodactyly, rheumatoid nodules, erythema multiforme, leg ulcers), or drug-induced lupus;\n16. Previously received other CAR-T therapies except CD19-CART.\n\n2.SSc\n\n1. Other connective tissue disease: Rheumatoid Arthritis, System Lupus or Inflammatory Myopathies;\n2. Clinical manifestations can be explained by disease similar to SSc: hand joint lesions related to nephrogenic systemic fibrosis, generalized morphea, eosinophilic fasciitis, diabetic scleredema, scleromyxedema, erythromelalgia, porphyria, lichen sclerosus, graft-versus-host disease, diabetes mellitus, and other endocrine and metabolic diseases;\n3. Patients who have severe active central nervous system (CNS) lupus, including epileptic seizures, pyschosis, cerebrovascular accident or CNS vasculitis requiring treatment intervention within 60 days after baseline;\n4. Dialysis patients or Ccr \\\u003C30ml\u002Fmin;\n5. Pregnant or suckling period;\n6. Combined with active infection (eg. septicemia, bacteremia, fungemia, uncontrolled pulmonary infection, and active tuberculosis);\n7. Detection positive: HBsAg, HbeAg; HBe-Ab, HBc-Ab (the copy number of HBV-DNA is greater than the measurable low limit); HCV-Ab, HIV-Ab, TP-Ab;\n8. Patients have undergone big surgeries which evaluated by investigators as unsuitable for enrollment within 4 weeks before screening;\n9. Previously received other CAR-T therapies except CD19-CART.\n\n3.pSS-PAH\n\n1. PH caused by other reasons: Portal hypertension, hereditary hemorrhagic telangiectasia, etc.; congenital heart disease; suspected drugs and toxicants; pulmonary hypertension related to chronic hypoxic diseases: moderate or severe obstructive pulmonary disease: FEV1 \\\u003C 55%; moderate or severe restrictive pulmonary disease: TLC \\\u003C 60%; pulmonary hypertension due to chronic thromboembolic disease: pulmonary ventilation\u002Fperfusion imaging suggests moderate or high suspicion of pulmonary thromboembolism;\n2. Patients who have severe active central nervous system (CNS) lupus, including epileptic seizures, pyschosis, cerebrovascular accident or CNS vasculitis requiring treatment intervention within 60 days after baseline;\n3. Dialysis patients or Ccr \\\u003C30ml\u002Fmin;\n4. Pregnant or suckling period;\n5. Combined with active infection (eg. septicemia, bacteremia, fungemia, uncontrolled pulmonary infection, and active tuberculosis).\n6. Detection positive: HBsAg, HbeAg; HBe-Ab, HBc-Ab (the copy number of HBV-DNA is greater than the measurable low limit); HCV-Ab, HIV-Ab, TP-Ab;\n7. Patients have undergone big surgeries which evaluated by investigators as unsuitable for enrollment within 4 weeks before screening;\n8. Previously received other CAR-T therapies except CD19-CART.\n\n6\\) Detection positive: HBsAg, HbeAg; HBe-Ab, HBc-Ab (the copy number of HBV-DNA is greater than the measurable low limit); HCV-Ab, HIV-Ab, TP-Ab; 7) Patients have undergone big surgeries which evaluated by investigators as unsuitable for enrollment within 4 weeks before screening; 8) Previously received other CAR-T therapies except CD19-CART. 4. AID\n\n1. Intracranial hypertension or disorder of consciousness;\n2. Symptomatic heart failure or severe arrhythmia;\n3. Symptoms of severe respiratory failure;\n4. Complicated with other types of malignant tumors;\n5. Diffuse intravascular coagulation;\n6. Suffering from septicemia or other uncontrollable infections;\n7. Patients with uncontrollable diabetes and other endocrine diseases;\n8. Severe mental disorders;\n9. Obvious and active intracranial lesions were detected by cranial magnetic resonance imaging (MRI);\n10. Have received organ transplantation (excluding bone marrow transplant);\n11. Reproductive-aged female patients with positive blood human chorionic gonadotropin (HCG) test;\n12. Positive screening for hepatitis (HBV and HCV included), HIV and syphilis;\n13. The subject is unable to undergo PBMC collection, nor are there cryopreserved PBMCs available for CAR-T cell manufacturing;\n14. eGFR CKD-EPI \\\u003C 30 ml\u002Fmin\u002F1.73m\\^2.","10 Years","65 Years",{"count":326,"type":22},45,[167,53],"This is a single-center, open-label, non-randomized, single-arm clinical trial. Patients with refractory lupus neritis (SLE-LN), systemic sclerosis (SSc), primary Sjogren syndrome combined with pulmonary artery hypertension (pSS-PAH) and other autoimmune diseases (AID) receive CD19-BCMA CAR T cell therapy. Phase I (Dose-Escalation\u002FDose-De-escalation Phase)：The primary objective is to prospectively assess the safety of CD19-BCMA CAR T cell therapy in patients with SLE-LN, SSc, pSS-PAH and other autoimmune diseases (AID).Phase I (Dose-Escalation\u002FDose-De-escalation Phase)：Primary Endpoint: Safety, tolerability, and determination of the optimal biological dose (OBD) and the Phase II recommended dose (RP2D) in patients with SLE-LN, SSc, pSS-PAH, and other autoimmune diseases (AID).Phase II (Dose-Expansion Phase):Overall remission rate (ORR) \\[Time Frame: 90,180 Days\\]",[330,28,331,332],"Refractory Lupus Nephritis","Primary Sjogren's Syndrome Combined With Pulmonary Hypertension","Other Autoimmune Diseases (AID)",{"date":334,"type":33},"2026-07-30",{"date":336,"type":33},"2025-04-18",{"date":245,"type":22},{"name":339,"class":106},"Beijing GoBroad Hospital",{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":346,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":49,"enrollmentInfo":348,"targetDuration":4,"studyType":23,"phases":350,"briefSummary":351,"conditions":352,"keywords":353,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":364},"100615687","phase-1-a-study-of-azd0120-in-autoimmune-diseases-100615687","NCT07295847","A Study of AZD0120 in Autoimmune Diseases","A Phase 1b, Open-label, Multi-cohort Study of AZD0120, an Autologous CD19\u002FBCMA Targeting Chimeric Antigen Receptor T-cell, in Adults With Autoimmune Diseases","AURORA","Inclusion Criteria:\n\n* Capable of giving signed informed consent.\n* Adequate physiological function and reserve at screening.\n* Able to comply with recommended medication washout period.\n* Participants who are suitable for the study as determined by medical evaluation and at the discretion of the investigator.\n* Willingness to remain on\u002Fstart appropriate, highly effective methods of birth control or other acceptable criteria.\n\nExclusion Criteria:\n\n* BMI at screening \\\u003C 18 or \\> 35kg\u002Fm2.\n* Any prior CAR T exposure.\n* Unable or unwilling to remain within proximity (\\~2 hours travel time) of the administering investigational site for the first 28 days post study drug administration.\n* Received a bone marrow or solid organ transplant at any time or on an active transplant waiting list.\n* Received any investigational drug within ≥ 5 half-lives or 4 weeks, whichever is longer, prior to screening.\n* Has certain heart conditions that could make it unsafe or unsuitable to take part in the study.\n* Requirement for supplemental oxygen at rest (except at night for sleep apnea) or mechanical ventilation.\n* Uncontrolled hypertension (\\> 160\u002F100 mmHg) or symptomatic hypertension.\n* Any central nervous system disease that may impact participants safety in the investigator's opinion.\n* Other concurrent autoimmune or autoinflammatory disease. Certain autoimmune\u002Fautoinflammatory diseases may be included after discussion with the medical monitor.\n* Evidence of clinically significant bleeding or active bleeding conditions within 90 days before screening\n* History of malignancy or ongoing treatment for prior malignancy. Certain malignancies may be excepted.\n* Known genetic inborn error of immunity and\u002For primary immunodeficiency.\n* Active viral, bacterial, or fungal infection, or any ongoing infection that requires systemic antimicrobial therapy in the 4 weeks prior to screening.\n* Seropositive for HIV.\n* Active viral hepatitis are excluded.\n* Active syphilis, positive for Treponema pallidum antibody.\n* Vaccinated with live, attenuated vaccine within 4 weeks prior to apheresis or lymphodepletion.\n* Not up-to-date on vaccinations per local\u002Fnational health authority or institutional guidelines for immune-compromised individuals.\n* Known life threatening allergies, hypersensitivity, or intolerance to AZD0120 or its excipients, including dimethyl sulfoxide.\n* Contraindications or hypersensitivity to fludarabine and cyclophosphamide.\n* Major surgery, or has surgery planned during the study.\n* Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 1 year after receiving study treatment (whichever is later).\n* Plans to father a child while enrolled in this study or within 1 year after receiving study treatment (whichever is later).\n* Any issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to provide informed consent or any condition in the opinion of the investigator, participation would not be in the best interest of the participant.\n\nOther protocol-defined eligibility criteria may apply.",{"count":349,"type":22},27,[167],"This trial is a Phase 1b, open-label, multi-center, clinical study of AZD0120, a BCMA\u002FCD19 dual targeting CAR+ T-cell therapy, to evaluate the safety and tolerability in adult participants with systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM), or difficult-to-treat rheumatoid arthritis (D2T RA).",[28,127,128],[28,127,128,354,355,180],"CAR-T","BCMA",{"date":357,"type":33},"2026-07-28",{"date":359,"type":33},"2026-01-09",{"date":361,"type":22},"2028-02-22",{"name":363,"class":40},"AstraZeneca",22,{"id":366,"slug":367,"hasResults":12,"nctId":368,"briefTitle":369,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":18,"minAge":372,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":23,"phases":375,"briefSummary":376,"conditions":377,"keywords":379,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":86},"100330481","phase-2-subcutaneous-injection-of-sodium-thiosulfate-for-ectopic-calcifications-or-ossifications-a-pilot-study-100330481","NCT03582800","Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot Study","ITS-PILOT","Inclusion Criteria:\n\n* Patient presenting with:\n\n  * ectopic ossification secondary to iPPSD2 or\n  * ectopic calcification secondary to dermatomyositis or\n  * ectopic calcification secondary to systemic sclerosis\n* Patient aged 2 years or over\n* Indication of STS infusion validated by a multidisciplinary committee, based on the significant morbidity and\u002For functional impact of the targeted calcification\u002Fossification\n* Patient with no planned surgery of the calcifications\u002Fossifications for the twelve coming months\n* Women of childbearing potential on highly effective contraception (such as hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence)\n* Men with women of childbearing potential partners should use condoms during the whole treatment period and until 91 days after the last injection.\n* Informed consent signed by the patient \u002F parents\n* Patient affiliated to the social security system\n\nExclusion Criteria:\n\n* Allergy to STS or one of the excipients used\n* Contraindication to local injection of STS\n* Anticoagulant therapy\n* Pregnant, parturient or breastfeeding woman\n* Patient deprived of freedom by a court judgment or an administrative decision\n* Patient undergoing psychiatric care under coercion\n* Legally protected adult patients (guardianship \u002F curatorship)\n* Patient unable to give consent\n* Patient placed under judicial protection","6 Months",{"count":374,"type":22},40,[53],"Ectopic soft tissue calcifications or ossifications can complicate the course of numerous diseases; most of them are rare or very rare. Even if the clinical, radiological and pathological presentation of ectopic calcifications and ossifications are different, the same hypotheses are discussed considering their hypothetical pathophysiology. Indeed, high calcium phosphate product, local cellular lesions and abnormal transdifferentiation of mesenchymal cells are regularly evoked when pathophysiology of such calcifications or ossifications are discussed. Apart from several case reports that have not been confirmed so far, no medical treatments are available, leading to significant pain and impairment of quality of life for patients. Therefore, only surgical treatment can be proposed when the volume or the consequences of these calcifications\u002Fossifications become too important.\n\nSodium thiosulfate (STS) is currently used as a cyanide poisoning antagonist and a chemoprotectant against adverse effects of several chemotherapies such as Cisplatin. Numerous case reports and several studies have revealed the potential interest of STS in the treatment of uremic induced vascular or soft tissues calcifications. Recently, our group has developed an expertise in the use of STS for the treatment of ectopic soft tissue calcifications or ossifications. Considering these promising preliminary data, and their limits, we developed a strategy to treat soft tissue calcifications or ossifications based on a local administration of STS. The first results of this therapeutic strategy are highly promising and the local or systemic safety is satisfactory so far. These preliminary data also reported by others deserve to be confirmed in a prospective study.\n\nWe propose in this project to conduct a prospective open controlled phase II trial in order to assess the efficacy and the safety of intralesional administration of STS for the treatment of calcifications secondary to dermatomyositis or systemic sclerosis and ectopic ossifications secondary to pseudo-hypoparathyroidism 1a type (PHP1A\u002FiPPSD2) (inactivating parathyroid hormone \u002F parathyroid-hormone-related peptid (PTH\u002FPTHrP) signalling disorder).",[28,301,378],"iPPSD2",[380,381,382],"Sodium thiosulfate","Ectopic calcification","Ectopic Ossification","2026-07-17",{"date":385,"type":33},"2026-07-20",{"date":387,"type":33},"2020-01-06",{"date":389,"type":22},"2029-06-06",{"name":391,"class":106},"University Hospital, Limoges",{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":398,"eligibilityCriteria":399,"healthyVolunteers":262,"sex":18,"minAge":400,"maxAge":49,"enrollmentInfo":401,"targetDuration":4,"studyType":23,"phases":402,"briefSummary":404,"conditions":405,"keywords":4,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":413,"leadSponsor":415,"locationsCount":4},"100648010","extracellular-vesicle-dynamics-predicting-vascular-complications-and-treatment-response-in-systemic-sclerosis-100648010","NCT07717060","Extracellular Vesicle Dynamics Predicting Vascular Complications and Treatment Response in Systemic Sclerosis","Extracellular Vesicle Dynamics Across the Circulatory System as Predictors of Major Vascular Complications and Therapeutic Response in Systemic Sclerosis Patients","EVOLVE-SSc","Inclusion Criteria:\n\nMale and female patients aged 45-75 years Diagnosis of systemic sclerosis according to the 2013 ACR\u002FEULAR classification criteria High risk of pulmonary arterial hypertension based on the DETECT algorithm Stable treatment with vasoactive, vasodilator, and immunosuppressive therapies for at least 3 months prior to blood sampling\n\nExclusion Criteria:\n\nPrevious diagnosis of pulmonary arterial hypertension confirmed by right heart catheterization Interstitial lung involvement affecting more than 10% of the lung parenchyma Left-sided heart failure (NYHA class 3-4) Evidence of chronic thromboembolic pulmonary disease on contrast-enhanced CT scan Major contraindications to right heart catheterization or coronary angiography Inability to provide informed consent","45 Years",{"count":264,"type":22},[403],"NA","Systemic sclerosis is a multisystem autoimmune disease characterized by vascular dysfunction, immune dysregulation, and progressive tissue fibrosis. Cardiopulmonary complications and peripheral vascular involvement are the principal causes of disability and mortality.\n\nExtracellular vesicles (EVs) have emerged as key mediators of paracrine intercellular communication. Preclinical studies further suggest that EVs mediate long-range inter-organ communication through the circulation. However, the inability to directly track EV trafficking in vivo in humans has limited the understanding of their contribution to systemic inter-organ communication.\n\nThe investigators propose that systemic sclerosis provides a unique human model for investigating circulating EV-mediated inter-organ communication in a multisystem disease. The central hypothesis is that arteriovenous differences in the molecular and cellular characteristics of circulating EVs reflect their dynamic exchange between individual organs and the bloodstream, and that these differences are associated with disease severity. Comparison of EVs across the circulation, rather than relying exclusively on peripheral blood samples, enables a more direct assessment of organ-specific EV release and uptake.\n\nCharacterizing EV dynamics along the circulatory pathway has the potential to identify novel biomarkers and therapeutic targets for systemic sclerosis while providing fundamental insights into EV-mediated inter-organ communication in humans.",[28,406,407,408],"Pulmonary Arterial Hypertension","Digital Ulcers","Vascular Complications","2026-07-16",{"date":411,"type":33},"2026-07-21",{"date":151,"type":22},{"date":414,"type":22},"2028-09-01",{"name":416,"class":106},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":163,"enrollmentInfo":424,"targetDuration":4,"studyType":23,"phases":426,"briefSummary":428,"conditions":429,"keywords":433,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":437,"completionDateStruct":438,"leadSponsor":440,"locationsCount":280},"100640182","early-phase-1-cd19bcma-targeted-universal-car-t-cell-injection-for-the-treatment-of-autoimmune-diseases-100640182","NCT07596680","CD19\u002FBCMA-Targeted Universal CAR-T Cell Injection for the Treatment of Autoimmune Diseases","Clinical Study on the Safety, Efficacy and Pharmacokinetics of Universal CD19\u002FBCMA-Targeted CAR-T Cell Injection in Patients With Autoantibody-Mediated Autoimmune Diseases","Inclusion Criteria\n\n1. General Inclusion Criteria (All Patients)\n\n   1. Voluntarily provides written informed consent.\n   2. Age ≥18 and ≤70 years, any gender.\n   3. Adequate organ function:\n\n      * ALT and AST ≤3×ULN; total bilirubin ≤2×ULN (excluding Gilbert syndrome).\n      * Creatinine ≤1.5×ULN or creatinine clearance ≥40 mL\u002Fmin.\n      * Neutrophils ≥1×10⁹\u002FL; hemoglobin ≥60 g\u002FL; platelets ≥20×10⁹\u002FL; lymphocytes \\>0.3×10⁹\u002FL.\n      * INR ≤1.5×ULN or PT ≤1.5×ULN.\n      * Resting room-air SpO₂ ≥92%.\n      * LVEF ≥50% on echocardiogram.\n   4. Negative serum or urine pregnancy test for females of childbearing potential at screening.\n   5. Highly effective contraception required from 28 days before lymphodepletion until 12 months after RD06-05 infusion for females; effective barrier contraception required from lymphodepletion until 12 months after RD06-05 infusion for males, with no sperm donation during the study.\n2. For SLE Patients\n\n   1. Diagnosis of SLE per 2019 EULAR\u002FACR or 2012 SLICC criteria.\n   2. Active disease despite ≥2 months of stable (≥2 weeks) treatment with glucocorticoids plus immunosuppressants and\u002For biologics; prednisone ≥7.5 mg\u002Fday or equivalent.\n   3. Positive ANA, anti-dsDNA antibody, and\u002For anti-Smith antibody at screening.\n   4. SLEDAI-2K \\>6 and clinical SLEDAI-2K ≥4 at screening. Patients with lupus nephritis (proteinuria \\>0.5 g\u002F24h, UPCR \\>500 mg\u002Fg, or active urinary sediment) are exempt from clinical SLEDAI-2K requirement.\n   5. Physician Global Assessment (PGA) ≥1.0 (0-3 VAS) at screening.\n3. For SSc Patients\n\n   1. Diagnosis of SSc per 2013 ACR\u002FEULAR criteria.\n   2. Diffuse cutaneous SSc at screening.\n   3. Active disease defined by at least one of: new SSc within 2 years; new\u002Fworsening skin or thoracic\u002Fabdominal involvement within 6 months; worsening skin thickening (mRSS ≥2); tendon friction rubs within 3 months; worsening respiratory symptoms with FVC decline ≥5% predicted or DLCO decline ≥10% predicted; or ILD progression on HRCT compared to 12 months prior.\n   4. Refractory or relapsing disease after \\>6 months of conventional therapy including glucocorticoids, cyclophosphamide, immunosuppressants, and\u002For biologics.\n4. For AAV Patients\n\n   1. Diagnosis of ANCA-associated vasculitis (MPA, GPA, EGPA) per 2022 ACR\u002FEULAR criteria.\n   2. Positive MPO-ANCA or PR3-ANCA.\n   3. BVAS with at least 1 major item, 3 minor items, or 2 renal items.\n   4. Failure of standard of care: no remission after ≥4 months of glucocorticoids plus cyclophosphamide\u002Frituximab; relapse after prior remission; or persistent active disease despite ≥6 months of SOC.\n5. For IIM Patients\n\n   1. Diagnosis of IIM (DM, ASS, IMNM) per 2017 ACR\u002FEULAR criteria (probability ≥55%).\n   2. Active disease defined by ≥2 abnormal core measures, or active myositis on muscle MRI, or active inflammation on muscle biopsy within 16 weeks.\n   3. Positive myositis-specific autoantibodies.\n   4. Refractory or relapsing disease after ≥6 months of conventional therapy including glucocorticoids, immunosuppressants, and\u002For biologics.\n6. For pSS Patients\n\n   1. Diagnosis of primary Sjögren's syndrome per 2016 ACR\u002FEULAR criteria.\n   2. Positive anti-SSA\u002FRo antibody.\n   3. ESSDAI ≥6 at screening.\n   4. Refractory or relapsing disease after ≥6 months of conventional therapy including glucocorticoids, immunosuppressants, and\u002For biologics.\n\nExclusion Criteria:\n\n1. General Exclusion Criteria (All Patients):\n\n   1. Coexisting autoimmune disease confounding disease activity\u002Fsafety (stable ≥3 months may be eligible with approval).\n   2. Anti-CD20 mAb\u002FT-cell engager within 3 months; CD19\u002FBCMA-targeted therapy within 6 months (exception with CD19⁺ B-cell \\> LLN and approval).\n   3. Rapidly progressive glomerulonephritis (RPGN).\n   4. NYHA III\u002FIV heart failure; severe cardiac disease within 12 months.\n   5. Severe CNS disease impairing compliance\u002Fassessments.\n   6. Malignancy history (except cured non-melanoma skin cancer\u002Fcarcinoma in situ, disease-free ≥3 years).\n   7. Primary immunodeficiency.\n   8. Uncontrolled infection (uncomplicated UTI\u002Fupper respiratory infection permitted).\n   9. Positive HIV; positive HCV (except undetectable RNA); positive syphilis.\n   10. Positive HBsAg; positive HBcAb (except undetectable HBV DNA).\n   11. Positive EBV\u002FCMV DNA\u002FIgM at screening.\n   12. Active\u002Frecurrent tuberculosis.\n   13. Prior CAR-T or genetically modified immune cell therapy.\n   14. Live attenuated vaccine within 4 weeks before enrollment.\n   15. Hypersensitivity to cell therapy product components.\n   16. Tacrolimus hypersensitivity or ≥Grade 3 toxicity requiring hospitalization.\n   17. Other clinical trial participation within 30 days before screening.\n   18. Pregnant\u002Fbreastfeeding; childbearing potential unwilling to use effective contraception.\n   19. Any other ineligible condition (investigator judgment).\n2. Exclusion Criteria for SLE\n\n   1. Active\u002Funstable neuropsychiatric SLE requiring intervention within 90 days.\n   2. Anti-BAFF\u002FAPRIL therapy within required washout period; multiple NSAIDs within 14 days; inability to hold NSAIDs; intra-articular glucocorticoids within 6 weeks; immunosuppressants exceeding dose limits; hydroxychloroquine dose adjustment within 8 weeks; ACEI\u002FARB\u002FSGLT2i adjustment within 4 weeks.\n3. Exclusion Criteria for AAV\n\n   1. Alveolar hemorrhage requiring invasive ventilation beyond screening.\n   2. Dialysis\u002Fplasmapheresis within 12 weeks.\n   3. Renal transplantation history.\n   4. Cyclophosphamide within 12 weeks; immunosuppressant discontinuation required 1 week before lymphodepletion.\n   5. High-dose IV glucocorticoids within 4 weeks.\n   6. Oral glucocorticoids \\>60mg prednisone equivalent daily for \\>6 weeks.\n   7. Specific immunosuppressants\u002Fbiologics within 4 weeks.\n   8. Concomitant strong CYP3A4 inducers.\n4. Exclusion Criteria for IIM\n\n   1. Severe rhabdomyolysis or CK ≥120×ULN at screening.\n   2. FVC ≤50% predicted or DLCO ≤40% predicted at screening.\n5. Exclusion Criteria for SSc\n\n   1. Significant respiratory disease other than ILD.\n   2. FVC \\\u003C50% or DLCO \\\u003C40% predicted at screening\u002Fbaseline.\n   3. Lung transplantation listing\u002Fexpected within 12 months.\n   4. Scleroderma renal crisis within 6 months.\n   5. Scleroderma-like disorders.\n   6. Prior chlorambucil, bone marrow transplantation, or total lymphoid irradiation.\n6. Exclusion Criteria for pSS\n\n   1. Active fibromyalgia interfering with assessment\u002Frequiring medication adjustment (stable permitted).\n   2. Cyclophosphamide within 12 weeks; immunosuppressant discontinuation required 1 week before lymphodepletion.\n   3. High-dose glucocorticoids (≥60mg\u002Fday) within 4 weeks.",{"count":425,"type":22},30,[427],"EARLY_PHASE1","This is a single-arm, open-label, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with autoantibody-mediated autoimmune diseases. The enrolled population consists of patients with active autoimmune diseases, including systemic lupus erythematosus (SLE), systemic sclerosis (SSc), ANCA-associated vasculitis (AAV), idiopathic inflammatory myopathies (IIM), Sjögren's syndrome (SS), among others.\n\nThe CAR-T cell dose used in this study is 6×10⁶ CAR⁺ T cells\u002Fkg. Six subjects will be enrolled for each indication, with a total of 30 subjects to be enrolled.",[430,28,431,127,432],"SLE - Systemic Lupus Erythematosus","ANCA Associated Vasculitis","Sjögren Syndrome",[434],"CD19\u002FBCMA CAR-T","2026-07-15",{"date":409,"type":33},{"date":151,"type":22},{"date":439,"type":22},"2029-04-30",{"name":441,"class":40},"Nanjing Bioheng Biotech Co., Ltd.",{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":448,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":84,"enrollmentInfo":450,"targetDuration":4,"studyType":23,"phases":451,"briefSummary":452,"conditions":453,"keywords":455,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":463,"leadSponsor":465,"locationsCount":280},"100645858","early-phase-1-hyaluronidase-for-sclerodactyly-in-systemic-sclerosis-trial-100645858","NCT07697274","Hyaluronidase for Sclerodactyly in Systemic Sclerosis Trial","Digital Intradermal Hyaluronidase for Sclerodactyly in Systemic Sclerosis","HASSc","Inclusion Criteria:\n\n* Age ≥18 and \\\u003C60 years\n* Diagnosis of systemic sclerosis\n* Presence of sclerodactyly\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Known hypersensitivity to hyaluronidase\n* Pregnancy or breastfeeding\n* Unstable systemic disease\n* Recent changes in systemic immunomodulatory therapy\n* Conditions interfering with safe digital injections",{"count":74,"type":22},[427],"Translational studies have demonstrated reduced hyaluronidase activity in the skin of patients with systemic sclerosis. It is thought this may contribute to the progressive fibrosis seen in this disease. Several studies have demonstrated that exogenous hyaluronidase is very effective at improving systemic sclerosis associated microstomia. Therefore, this study aims to explore hyaluronidase for systemic sclerosis associated sclerodactyly.",[28,454],"Sclerodactyly",[456,457,458,303],"Hyaluronidase","Digital fibrosis","Hand function","2026-07-08",{"date":461,"type":33},"2026-07-13",{"date":151,"type":22},{"date":464,"type":22},"2027-11",{"name":466,"class":106},"Medical University of South Carolina",{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":473,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":475,"enrollmentInfo":476,"targetDuration":4,"studyType":23,"phases":478,"briefSummary":479,"conditions":480,"keywords":481,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":495},"100446843","phase-2-preventive-effect-of-clopidogrel-on-the-systemic-sclerosis-development-risk-100446843","NCT05098704","Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk","Phase II\u002FIII Double-blind Randomized Placebo-controlled Trial Assessing the Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk in Subjects With Specific Dysimmunity and Raynaud Phenomenon","PSSIT","Inclusion Criteria:\n\n* Patient over 18 years old, and less than 85 years old.\n* Patient with positive AAN (AAN ≥ 1\u002F160) with the following specificity: anti-Scl70 or anti-centromere or anti-RNApolIII, or any other auto-antibodies related to systemic sclerosis\n* Patient with RP reported by the subject and confirmed by the physician.\n* Patient affiliated to a health insurance system.\n* Patient who accepts to participate to the study and signs an inform consent form.\n\nExclusion Criteria:\n\n* Patient with an SSc diagnosis according to ACR\u002FEULAR 2013 criteria.\n* Patient with skin fibrosis at screening.\n* Patient with antiplatelet treatment at screening.\n* Patient with contraindications to clopidogrel.\n* Patient treated by immunosuppressive agent at screening.\n* Patient treated by anticoagulants at screening\n* Pregnant or breastfeeding women.\n* Women of childbearing age refusing effective contraception method during the study treatment (24 months).\n* Incompetent adults (i.e. Individuals under the protection of a conservator)","85 Years",{"count":477,"type":22},90,[53,25],"Systemic sclerosis (SSc) is a severe autoimmune disease associating dysimmunity, vasculopathy and fibrosis. No curative treatment is available. Pre-clinical abnormalities can be found such as specific autoantibodies. The association of Raynaud phenomenon and SSc-specific anti-nuclear antibodies is the hallmark of pre-scleroderma subjects, among who around 47% declare a complete disease after five years. The aim of this study is to assess in this particular population the preventive effect of an anti-platelet treatment.",[56,28],[62,482,483,484,485],"clopidogrel","platelet","prevention","primary care","2026-07-03",{"date":488,"type":33},"2026-07-07",{"date":490,"type":33},"2022-06-22",{"date":492,"type":22},"2032-06",{"name":494,"class":106},"University Hospital, Bordeaux",11,{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":502,"eligibilityCriteria":503,"healthyVolunteers":262,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":504,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":506,"conditions":507,"keywords":510,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":280},"100632588","immun4cure-cohort-of-autoimmune-diseases-100632588","NCT07515638","Immun4Cure Cohort of Autoimmune Diseases","Prospective Cohort Study of Clinical and Biological Data in Patients With Autoimmune Diseases (Immun4Cure Cohort)","Immun4Cure","Inclusion Criteria Participants:\n\nGroup 1: RA\n\n* Adults ≥18 years\n* Patient followed as part of their MAI in one of the departments participating in the study at UHM\n* Confirmed diagnosis according to international criteria :ACR\u002FEULAR 2010\n\nGroup 2: LES\n\n* Adults ≥18 years\n* Patient followed as part of their MAI in one of the departments participating in the study at UHM\n* Confirmed diagnosis according to international criteria :ACR\u002FEULAR 2019\n\nGroup 3: SSc\n\n* Adults ≥18 years\n* Patient followed as part of their MAI in one of the departments participating in the study at UHM\n* Confirmed diagnosis according to international criteria :ACR\u002FEULAR 2013\n\nGroup 4: Healthy Controls\n\n* Adults ≥18 years\n* No symptoms of autoimmune disease\n* No first-degree family history of autoimmune disease\n\nExclusion Criteria (all groupes):\n\n* Patients who have refused or are unable to give informed consent\n* Inability to follow the subject during the study period\n* Participation in another interventional study that includes an exclusion period that is still ongoing\n* Pregnant women\n* Not affiliated with a social security scheme\n* Patients without a national insurance number\n* Persons under judicial protection, guardianship or trusteeship\n* Persons deprived of their liberty",{"count":505,"type":22},500,"This prospective cohort study aims to constitute a 500-participant database and biobank including 450 adults with systemic autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis) and 50 healthy controls.",[128,508,28,509],"Systemic Lupus Erythematosus","Healthy Adult Volunteers",[303,511,512],"multi-omic profiling","immunology","2026-06-26",{"date":515,"type":33},"2026-06-30",{"date":517,"type":33},"2026-06-23",{"date":519,"type":22},"2034-06-23",{"name":521,"class":106},"University Hospital, Montpellier",{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":163,"enrollmentInfo":529,"targetDuration":4,"studyType":23,"phases":530,"briefSummary":531,"conditions":532,"keywords":537,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":544,"locationsCount":280},"100644891","phase-1-a-study-of-c-car168-in-the-treatment-of-autoimmune-diseases-refractory-to-standard-therapy-100644891","NCT07676266","A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy","An Exploratory Clinical Study of Anti-CD20\u002FB-cell Maturation Antigen (BCMA) Chimeric Antigen Receptor Autologous T Cell Product (C-CAR168) in the Treatment of Autoimmune Diseases Refractory to Standard Therapy","Inclusion Criteria:\n\n* 18 to 70 years old at the time of signing the Informed Consent Form (ICF).\n* Diagnosed as Multiple sclerosis (MS)\u002FNeuromyelitis Optica Spectrum Disorders (NMOSD)\u002FMyasthenia Gravis (MG)\u002FSystemic Lupus Erythematosus (SLE)\u002F Systemic Sclerosis (SSc)\u002F Immune-Mediated Necrotizing Myopathy (IMNM) according to recognized diagnostic criteria for at least 6 months.\n* Prior treatment failure with standard therapy.\n* Adequate bone marrow, coagulation, cardiopulmonary, liver and renal function.\n\nExclusion Criteria:\n\n* Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Treponema Pallidum (TP) positive, Cytomegalovirus (CMV) DNA positive, Epstein-Barr Virus (EBV) DNA positive.\n* Uncontrolled active infection.\n* Live vaccine injection within 4 weeks prior to signing the ICF.\n* Major organ transplantation history or bone marrow\u002Fhematopoietic stem cell transplantation history.\n* Severe cardiovascular diseases within the past 6 months prior to screening.\n* A history of ≥ Grade 2 bleeding within 4 weeks prior to screening, or requiring long-term anticoagulants treatment.\n* Inadequate washing time for previous treatment.\n* Previously treated with CAR-T cell products or genetically modified T cell therapies.\n* Pregnant or lactating women.\n* Severe central nervous system diseases or pathological changes.\n* Malignancy history within 5 years prior to signing the ICF.\n* Any contraindication to lumbar puncture for MS or NMOSD.",{"count":230,"type":22},[167],"This is an investigator-initiated, single-center, open-label study of C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, for the treatment of adult patients with autoimmune diseases refractory to standard therapy",[533,534,535,508,28,536],"Multiple Sclerosis (MS)","Myasthenia Gravis (MG)","Neuromyelitis Optica Spectrum Disorder","Immune-Mediated Necrotizing Myopathy",[538],"CD20\u002FBCMA-directed CAR-T cells","2026-06-24",{"date":515,"type":33},{"date":542,"type":22},"2026-07",{"date":227,"type":22},{"name":545,"class":106},"The Affiliated Hospital of Qingdao University",{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":552,"eligibilityCriteria":553,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":554,"targetDuration":556,"studyType":118,"phases":4,"briefSummary":557,"conditions":558,"keywords":559,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":561,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":280},"100480198","prospective-cohort-of-patients-with-systemic-sclerosis-at-brest-university-hospital-with-biobanking-100480198","NCT05532865","Prospective Cohort of Patients With Systemic Sclerosis at Brest University Hospital With Biobanking","Prospective Cohort of Patients With Systemic Sclerosis at Brest University Hospital and Constitution of a Biobank","SCLEROBREST","Inclusion Criteria:\n\n* Major patient with systemic sclerosis defined according to the EULAR 2013 criteria (see Appendix 1)\n* Patient evaluated within the framework of the reference center for rare autoimmune diseases of the CHU of Brest.\n* Patient affiliated to the social security system\n* Patient having signed a written informed consent.\n\nExclusion Criteria:\n\n* Minor\n* Patient under legal protection (guardianship, curatorship)\n* Refusal to participate\n* Patient unable to consent\n* Pregnant or breastfeeding woman\n* Hemoglobin (Hb) level \\\u003C 7g\u002Fdl",{"count":555,"type":22},100,"5 Years","This study corresponds to a monocentric prospective cohort of adult patients with systemic sclerosis.\n\nIt will allow the constitution of an organized collection of longitudinal clinical data as well as collection of biological samples, including blood samples, as well as stool sample and skin swab for microbiota analysis.",[28],[28,560],"Patient library",{"date":513,"type":33},{"date":563,"type":33},"2022-10-13",{"date":565,"type":22},"2032-10-13",{"name":567,"class":106},"University Hospital, Brest",{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":4,"eligibilityCriteria":574,"healthyVolunteers":262,"sex":18,"minAge":19,"maxAge":49,"enrollmentInfo":575,"targetDuration":4,"studyType":23,"phases":577,"briefSummary":578,"conditions":579,"keywords":580,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":588,"locationsCount":4},"100642293","phase-1-a-trial-in-healthy-adult-participants-and-adults-with-autoimmune-disease-to-test-how-hbm7020-is-tolerated-and-absorbed-in-the-body-100642293","NCT07649265","A Trial in Healthy Adult Participants and Adults With Autoimmune Disease to Test How HBM7020 is Tolerated and Absorbed in the Body","A Phase 1 Open-Label, Multicenter Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of HBM7020 in Healthy Adult Participants and Adults With Seropositive Autoimmune Disease","Key Inclusion Criteria for Healthy Participants (Part 1)\n\n1. Participants who are of non-childbearing potential or are using acceptable contraception.\n2. Body mass index (BMI) and body weight within an acceptable range.\n3. Good general health based on medical history, physical examination, electrocardiogram (ECG), and laboratory assessments.\n\nKey Disease-Agnostic Inclusion Criteria for Patient Participants (Part 1)\n\n1. BMI and body weight within an acceptable range.\n2. Adequate hematologic, renal, hepatic, immunologic, and lymphocyte parameters.\n\nKey Disease-Specific Inclusion Criteria for Patient Participants (Part 1)\n\n1. Confirmed autoimmune disease with appropriate supporting autoantibody findings.\n2. Stable background therapy prior to dosing.\n3. Active moderate to severe disease consistent with protocol-defined disease activity criteria for:\n\n   * Systemic lupus erythematosus (SLE)\n   * Systemic sclerosis (SSc)\n   * Rheumatoid arthritis (RA)\n   * Sjögren's disease (SjD)\n\nKey Inclusion Criteria for Rescreening Participants (Part 2)\n\n1. Meets Part 1 disease-agnostic inclusion criteria.\n2. Stable background autoimmune therapy prior to dosing.\n3. Ongoing active moderate to severe disease based on protocol-defined disease-specific criteria.\n\nKey Exclusion Criteria for Parts 1 and 2\n\n1. Pregnant or breastfeeding participants.\n2. Recent vaccination within protocol-defined timelines.\n3. Clinically significant medical history or abnormal physical examination findings.\n4. Clinically significant cardiovascular abnormalities, including blood pressure, heart rate, syncope, or ECG findings.\n5. Prior or recent therapies or conditions that may interfere with study participation or safety evaluations.\n6. Severe pulmonary, renal, or cardiac disease, or clinically significant pulmonary hypertension.",{"count":576,"type":22},63,[167],"This first-in-human study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of HBM7020. The study will enroll healthy participants at low doses, followed by participants with moderate to severe autoimmune diseases with predominant B-cell involvement. Eligible participants include patients with systemic lupus erythematosus (SLE), systemic sclerosis (SSc), Sjögren's disease (SjD), and rheumatoid arthritis (RA).",[128,508,28,269],[303],"2026-06-11",{"date":583,"type":33},"2026-06-16",{"date":585,"type":22},"2026-09-15",{"date":587,"type":22},"2028-11-20",{"name":589,"class":40},"Otsuka Pharmaceutical Development & Commercialization, Inc.",{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":594,"acronym":595,"eligibilityCriteria":596,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":597,"targetDuration":4,"studyType":23,"phases":598,"briefSummary":599,"conditions":600,"keywords":604,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":606,"lastUpdatePostDateStruct":607,"startDateStruct":609,"completionDateStruct":610,"leadSponsor":612,"locationsCount":280},"100452889","efficacy-of-a-personalized-rehabilitation-program-of-facial-involvement-in-systemic-sclerosis-100452889","NCT05177380","Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis","PREVISS","Inclusion Criteria:\n\n* Age ≥ 18 yo\n* Systemic sclerosis according to the 2013 ACR\u002FEULAR (American College of Rheumatology) classification criteria\n* Systemic sclerosis with facial involvement defined by a MHISS score \\> 6\n* Immunosuppressive and\u002For anti-fibrosis treatment stable for at least 1 month\n* Subject able to understand the objectives and risks of research and to give informed consent\n* Subject enrolment in the health insurance scheme\n\nExclusion Criteria:\n\n* Pregnancy\n* Previous participation in a rehabilitation program of facial involvement\n* Patient under legal protection\n* Impossibility to give clear information of subject",{"count":264,"type":22},[403],"Systemic sclerosis is a rare autoimmune disorder characterized by microangiopathy, activation of the immune system, and sclerosis of tissues including the skin. Facial involvement is frequent and disabling. It causes significant functional and aesthetic discomfort, and a major deterioration in quality of life. It results in a loss of suppleness of the skin and subcutaneous tissues, dysfunction of the temporomandibular joint, peribuccal rhagades, microstomia, and dry mouth causing difficulties in mouth opening, feeding, dental care, and weight loss.\n\nFacial involvement in systemic sclerosis can be assessed using the Mouth Handicap in Systemic Sclerosis (MHISS) score, a validated patient questionnaire assessing the functional and aesthetic consequences of systemic sclerosis on the face.\n\nAlthough common and disabling, facial involvement is underestimated and poorly managed. Immunosuppressive and\u002For anti-fibrosis drugs are not very effective. Facial rehabilitation could significantly improve the mouth handicap but facial rehabilitation is not currently performed in standard care in systemic sclerosis patients.\n\nThe aim of the study is to evaluate the efficacy of a personalized rehabilitation program vs standard care in facial involvement of systemic sclerosis patients.",[28,601,602,603],"Face","Facial Involvement","Rehabilitation",[601,605,603,182],"Facial involvement","2026-06-05",{"date":608,"type":33},"2026-06-08",{"date":563,"type":33},{"date":611,"type":22},"2029-12",{"name":613,"class":106},"University Hospital, Strasbourg, France",{"id":615,"slug":616,"hasResults":12,"nctId":617,"briefTitle":618,"officialTitle":618,"acronym":619,"eligibilityCriteria":620,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":621,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":623,"conditions":624,"keywords":629,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":638,"lastUpdatePostDateStruct":639,"startDateStruct":640,"completionDateStruct":642,"leadSponsor":644,"locationsCount":280},"100598885","eacvi-study-on-multimodality-cardiovascular-imaging-of-inflammatory-cardiovascular-diseases-100598885","NCT07077304","EACVI Study on Multimodality Cardiovascular Imaging of Inflammatory Cardiovascular Diseases","EACVI-INFLAME","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Ability to provide informed non-opposition\n3. Referred for a CMR and\u002For nuclear imaging exam\n\nAND a suspicion of one of the following ICARDs :\n\n1. Suspected Myocarditis (acute or chronic, and whatever the aetiologies)\n2. Suspected Myocardial Infarction with Non-Obstructive Coronary Arteries (MINOCA)\n3. Suspected Tako-Tsubo\n4. Suspected Pericarditis (acute or chronic, and whatever the aetiologies)\n5. Suspected Connective tissue disease with cardiovascular involvement:\n\n   * Systemic sclerosis\n   * Systemic lupus erythematosus\n   * Antiphospholipid syndrome\n   * Idiopathic inflammatory myopathies\n   * Rheumatoid arthritis, spondylarthritis\n6. Suspected Vasculitis with cardiovascular involvement:\n\n   * Small-vessel vasculitis (ANCA…)\n   * Large vessel vasculitis (Behcet disease, Takayasu…)\n7. Suspected Inflammatory disease with cardiovascular involvement:\n\n   * Sarcoidosis\n   * Still disease\n\nExclusion Criteria:\n\n1. Inability to provide non-opposition\n2. History of heart transplant",{"count":622,"type":22},5000,"Inflammatory Cardiovascular Diseases and Autoimmune Rheumatic Diseases (ICARDs) encompass cardiovascular involvement in connective tissue diseases, vasculitis, and primary inflammatory cardiac processes affecting all layers of the heart. ICARDs are associated with increased cardiovascular morbidity and mortality, independently of traditional risk factors, via multiple pathophysiological mechanisms.\n\nDiagnosis and prognosis are challenged by the heterogeneity of clinical presentations. Multimodality cardiovascular imaging - including cardiovascular magnetic resonance (CMR), transthoracic echocardiography, and positron emission tomography (PET) - plays a central role in detecting and characterizing inflammatory involvement, and may offer prognostic insights.\n\nGiven the limited data on the diagnostic and prognostic utility of these imaging modalities in ICARDs, the EACVI-INFLAME study aims to assess the prevalence of confirmed cardiovascular involvement in patients with suspected or established ICARDs undergoing CMR and\u002For cardiac PET in a multicentric international cohort.",[123,431,121,28,508,127,128,625,626,131,627,134,628],"Spondylarthritis","Behcet Disease","Sarcoidosis","Tako Tsubo Cardiomyopathy",[630,631,632,633,634,635,636,637],"Cardiovascular disease","Auto-immune disease","Auto-inflammatory disease","Rheumatic disease","CMR","PET","multimodality imaging","ICARD","2026-06-03",{"date":606,"type":33},{"date":641,"type":33},"2025-11-19",{"date":643,"type":22},"2028-10-30",{"name":155,"class":106},{"id":646,"slug":647,"hasResults":12,"nctId":648,"briefTitle":649,"officialTitle":649,"acronym":650,"eligibilityCriteria":651,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":652,"targetDuration":4,"studyType":23,"phases":654,"briefSummary":655,"conditions":656,"keywords":663,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":669,"lastUpdatePostDateStruct":670,"startDateStruct":672,"completionDateStruct":674,"leadSponsor":676,"locationsCount":280},"100388150","deployment-o-the-multidisciplinary-prospective-cohort-imminent-100388150","NCT04334031","Deployment o the Multidisciplinary Prospective Cohort Imminent","IMMINeNT","Inclusion Criteria:\n\n* Patient followed for their IMID in one of the departments of the Lille University Hospital participating in the study (dermatology, internal medicine, neurology, pneumology and rheumatology)\n* Social insured\n* Have the capacity to understand the study requirements, provide written informed consent, and comply with the study data collection procedures.\n\nExclusion Criteria:\n\n* Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of coverage by the social security system.\n* Pregnant or breastfeeding woman\n* Persons deprived of liberty\n* Protected minors or adults\n* Persons who have refused or are incapable of giving informed consent\n* Persons in Emergency Situations",{"count":653,"type":22},2200,[403],"Immune-mediated inflammatory diseases (IMIDs) most often affect young patients and have high impact on morbidity and mortality with a significant alteration in the quality of life of patients with professional, social and emotional repercussions.\n\nBeyond this burden, IMIDs share many common pathophysiological mechanisms and treatments, known as \"targeted therapies\". Despite progress in this field, much remains to be done in clinical, therapeutic and fundamental research to address the efficacy, resistance and side-effects of treatment.\n\nThese similarities between IMIDs have led the FHU IMMINeNT to propose the creation of a prospective, multidisciplinary clinical-biological database (IMMINeNT cohort), associated to a biobank, of patients with IMIDs. The main objectives of this database will be to identify new prognostic and therapeutic biomarkers in order to develop new therapeutic targets and biomarkers, to identify prognostic factors and determinants related to the activity, severity and quality of life of patients with IMIDs as well as to the response and tolerance to treatment.",[657,658,659,125,660,661,662,28,133],"Chronic Inflammatory Disease","Angioedema","Severe Asthma","Atopic Dermatitis","Psoriatic Arthritis","Multiple Sclerosis",[664,665,666,667,668],"Immune Mediated Inflammatory Diseases (IMIDs)","biomarker","cohort study","quality of life","disease severity","2026-04-28",{"date":671,"type":33},"2026-05-05",{"date":673,"type":33},"2020-07-20",{"date":675,"type":22},"2031-07-21",{"name":677,"class":106},"University Hospital, Lille",{"id":679,"slug":680,"hasResults":12,"nctId":681,"briefTitle":682,"officialTitle":682,"acronym":4,"eligibilityCriteria":683,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":163,"enrollmentInfo":684,"targetDuration":4,"studyType":23,"phases":686,"briefSummary":687,"conditions":688,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":689,"lastUpdatePostDateStruct":690,"startDateStruct":692,"completionDateStruct":694,"leadSponsor":696,"locationsCount":280},"100635912","exploratory-clinical-study-of-anti-cd19bcma-universal-car-t-cell-injection-for-the-treatment-of-refractory-autoimmune-diseases-100635912","NCT07558850","Exploratory Clinical Study of Anti-CD19\u002FBCMA Universal CAR-T Cell Injection for the Treatment of Refractory Autoimmune Diseases","Inclusion Criteria:\n\n* Common Inclusion Criteria\n\n  1. Voluntarily sign an informed consent form, understand the study, and be willing and capable of completing all trial procedures.\n  2. Aged 18 to 70 years, regardless of gender.\n  3. At screening, the number of peripheral blood CD19-positive B cells determined by flow cytometry \\> 5 cells\u002FμL.\n  4. For subjects previously treated with B-cell targeted therapy, peripheral blood B cell counts have returned to normal or above pre-treatment levels at the screening visit.\n  5. Complete blood counts within 7 days prior to lymphodepleting chemotherapy meet the following requirements in patients with Sjögren's disease (SjD):\n\n     Absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL Hemoglobin (Hb) ≥ 80 g\u002FL Platelet count (PLT) ≥ 50×10⁹\u002FL\n  6. Subjects have adequate hepatic, renal, pulmonary and cardiac function at screening visit, defined as:\n\n     Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN) Total bilirubin (TBIL) ≤ 1.5 × ULN; except for patients with Gilbert syndrome, whose TBIL must be ≤ 3.0 × ULN Renal function: estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin\u002F1.73m². Subjects with eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m² and\u002For receiving renal replacement therapy may be enrolled if the investigator assesses benefits outweigh risks and full informed consent is obtained from the subject or guardian.\n\n     Peripheral oxygen saturation (SpO₂) ≥ 92% under room air without oxygen supplementation; no clinically significant pleural effusion (excluding that related to the target indication).\n\n     Left ventricular ejection fraction (LVEF) ≥ 50%; no pericardial effusion confirmed by echocardiography (excluding indication-related effusion); no clinically significant abnormalities on electrocardiogram (ECG).\n  7. During the screening period, serum pregnancy test must be negative for fertile female subjects. Females who have undergone surgical sterilization or natural menopause for at least 2 years are considered non-fertile. Fertile female and male subjects must adopt highly effective contraceptive methods throughout the clinical study and for 1 year after the last study treatment. They shall also agree not to donate oocytes or sperm for assisted reproductive technology within 1 year following the final study treatment.\n\n     Specific Inclusion Criteria\n\n     Relapsed\u002FRefractory Rheumatoid Arthritis (RA)\n  8. Meet the 2010 ACR\u002FEULAR classification diagnostic criteria, diagnosed with moderate to severe active rheumatoid arthritis, with a confirmed RA diagnosis for ≥ 6 months.\n  9. Swollen joint count ≥ 6 (based on 66-joint assessment) and tender joint count ≥ 6 (based on 68-joint assessment) at screening.\n  10. C-reactive protein (CRP) ≥ 10 mg\u002FL or erythrocyte sedimentation rate (ESR) ≥ 28 mm\u002Fh at screening.\n  11. Definition of EULAR refractory rheumatoid arthritis:\n\n      Treatment failure: Patients received treatment in accordance with EULAR recommended guidelines, and failed to respond to ≥ 2 biological\u002Ftargeted synthetic disease-modifying antirheumatic drugs (b\u002FtsDMARDs) following failure of conventional synthetic DMARDs (csDMARDs).\n\n      ① Exclusions: Treatment access restricted to bDMARDs\u002FtsDMARDs due to socioeconomic factors.\n\n      ② If csDMARDs are contraindicated, treatment failure with ≥ 2 b\u002FtsDMARDs with distinct mechanisms of action also qualifies.\n\n      Both patients and physicians acknowledge persistent difficulties in managing RA symptoms.\n\n      Presence of at least one of the following five indicators suggestive of active or progressive disease:\n      1. Moderate or higher disease activity (DAS28-ESR \\> 3.2 or CDAI \\> 10);\n      2. Clinical signs and\u002For symptoms indicative of active disease;\n      3. Inability to taper glucocorticoids to ≤ 7.5 mg\u002Fday prednisone or equivalent dose;\n      4. Rapid radiographic progression (increase in modified van der Heijde Sharp score ≥ 5 points within 1 year);\n      5. Impaired quality of life secondary to RA, despite seemingly adequate disease control.\n\n      Dermatomyositis (DM)\n  12. Diagnosed with Dermatomyositis (DM) in accordance with the 2017 EULAR\u002FACR criteria for at least 24 weeks prior to informed consent (ICF) signing.\n  13. Meet the classification criteria for refractory DM, and satisfy criterion ① plus any one of criteria ②-⑤:① Insufficient response to glucocorticoids (prednisone 1-2 mg\u002Fkg\u002Fday or equivalent dose of other corticosteroids) combined or sequential treatment with at least two immunosuppressants, with glucocorticoid treatment lasting for no less than 3 months;② Rapid disease progression, and\u002For involvement of extrapulmonary organs including the heart and gastrointestinal tract, and\u002For significant interstitial lung disease;③ Calcification in subcutaneous, muscular and articular tissues;④ Recurrent rashes or cutaneous ulcers;⑤ Recurrent or persistent muscle weakness. MRI shows extensive diffuse muscle edema during the disease course, or CMAS score \\\u003C 48. At least two abnormal results among the five core parameters: Physician Global Assessment (PhGA) ≥ 2 cm, Patient Global Assessment (PtGA) ≥ 2 cm, Manual Muscle Test MDAAT ≥ 2, Health Assessment Questionnaire (HAQ) total score ≥ 0.25, muscle enzyme levels \\> 1.5 × upper limit of normal (ULN).\n  14. Patients with anti-synthetase syndrome and positive anti-synthetase antibodies meet DM criteria and may be enrolled directly.\n  15. Patients with immune-mediated necrotizing myopathy positive for SRP or HMGCR antibodies meet DM criteria and may be enrolled directly.\n\n      Systemic Lupus Erythematosus (SLE)\n  16. Diagnosed with adult systemic lupus erythematosus (SLE) in accordance with the 2019 EULAR\u002FACR SLE classification criteria for at least 12 weeks prior to signing the informed consent form (ICF).\n  17. Subjects with moderate to severe refractory SLE shall meet all of the following criteria:\n\n      Positive antinuclear antibody (ANA) with a titer \\>1:80 at screening visit; or anti-double stranded DNA antibody level above the laboratory normal reference range (excluding borderline values); or anti-Sm antibody level above the laboratory normal reference range.\n\n      BILAG score showing Grade A involvement in ≥1 organ system, or Grade B involvement in ≥2 organ systems at both screening and baseline visits.\n\n      SLEDAI-2000 score ≥ 8 at both screening and baseline visits. Insufficient clinical response following adequate standard-dose glucocorticoids, antimalarials, immunosuppressants, and at least one biological agent administered in combination or sequentially for ≥ 3 months prior to screening.\n  18. Subjects receiving hematopoietic growth factor supportive therapy, including erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF) and thrombopoietin (TPO), must have an interval of at least 2 weeks between the last dose of growth factor therapy and screening assessments.For subjects receiving blood product transfusions: platelet assessments at screening shall be separated by at least 1 week from the last platelet transfusion; hemoglobin assessments at screening shall be separated by at least 2 weeks from the last red blood cell transfusion.\n\n      Systemic Sclerosis (SSc)\n  19. Meet the 2013 ACR\u002FEULAR classification criteria for systemic sclerosis, with disease duration ≤ 60 months.\n  20. Positive for antinuclear antibody (ANA) or any SSc-specific autoantibody.\n  21. Modified Rodnan Skin Score (mRSS) ≥ 15 (full score: 51).\n  22. Meet the definition of refractory disease:\n\n      * Significant progressive involvement of skin and visceral organs; ② No obvious disease remission after more than 3 months of combined or sequential treatment with glucocorticoids and\u002For cyclophosphamide, plus one or more immunomodulatory agents including but not limited to antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, ciclosporin, and biological agents such as rituximab, belimumab, telitacicept.Alternatively, subjects meeting criteria for rapidly progressive disease with no response to conventional standard clinical therapy may be enrolled if the investigator determines that clinical benefits outweigh risks and full informed consent is obtained from the subject or legal guardian.\n\nExclusion Criteria:\n\n* Common Exclusion Criteria\n\n  1. History of malignant tumors (excluding cured and completely resected basal cell carcinoma, squamous cell skin carcinoma or cervical carcinoma in situ with a disease-free interval of at least 5 years post resection), or concurrent malignant tumors.\n  2. Complicated severe pulmonary diseases, including pulmonary hypertension graded ≥ Grade 3 per WHO functional classification, requirement for oxygen therapy via oxygen reservoir mask, non-invasive or invasive mechanical ventilation support at screening.\n  3. Known allergy, hypersensitivity, intolerance or contraindication to CD19\u002FBCMA CAR-NK cells or any investigational medicinal ingredients (including fludarabine, cyclophosphamide and tocilizumab), or history of severe anaphylactic reactions.\n  4. Evidence of severe active viral, bacterial infection or uncontrolled systemic fungal infection at screening or baseline visit.\n  5. Cardiac insufficiency classified as NYHA Class Ⅲ or Ⅳ according to New York Heart Association criteria (see Appendix).\n  6. Congenital heart disease prior to screening, history of acute myocardial infarction within 6 months, severe arrhythmia (including multifocal frequent supraventricular tachycardia, ventricular tachycardia, etc.), moderate to massive pericardial effusion, severe myocarditis; unstable vital signs requiring vasopressor support.\n  7. Active or uncontrolled infection requiring parenteral antimicrobial therapy at screening or baseline visit.\n  8. Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral HBV DNA level above upper limit of normal; positive HCV antibody with peripheral HCV RNA level above upper limit of normal; positive HIV antibody, positive syphilis serology, or positive cytomegalovirus (CMV) DNA.\n  9. History of severe herpes infection such as herpes encephalitis, ocular herpes or disseminated herpes; signs of herpes or varicella-zoster virus infection (particularly varicella and herpes zoster) within 12 weeks prior to screening.\n  10. Active tuberculosis, history of active tuberculosis, or negative interferon-gamma release assay for tuberculosis infection not achieved during screening period.\n  11. History of epilepsy or other active central nervous system disorders.\n  12. Subjects with acquired or congenital immunodeficiency diseases.\n  13. Any clinically significant cardiac, endocrine, hematological, hepatic, immune, metabolic, urinary, pulmonary, neurological, dermatological, psychiatric, renal disorders or major medical history that may interfere with KN3601 administration, as judged by the investigator.\n  14. Solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; acute graft-versus-host disease (GVHD) Grade ≥2 within 2 weeks prior to screening.\n  15. Administration of live vaccines within 4 weeks prior to screening.\n  16. Receipt of the following treatments within specified time windows before baseline visit:\n\n      B-cell depleting therapy within 26 weeks Anti-CD40 monoclonal antibody, belimumab, abatacept, anti-tumor necrosis factor-α biologics, immunoglobulin therapy or plasma exchange within 24 weeks JAK inhibitors or other kinase inhibitors within 12 weeks, unless explicitly permitted by the protocol Traditional Chinese medicines and proprietary Chinese medicines for Sjögren's disease within 4 weeks (including Tripterygium wilfordii, Tripterygium hypoglaucum, Tripterygium hypoglaucum root, Paeonia lactiflora, and preparations\u002Fsupplements containing the above ingredients) Prior treatments within 3 elimination half-lives, 4 weeks, or ongoing pharmacodynamic effect, whichever is longer Post prior B-cell depleting therapy with B lymphocyte count below lower limit of normal or baseline value, whichever is lower\n  17. Participation in other clinical trials within 3 months, excluding subjects confirmed not to receive investigational drugs or devices.\n  18. Any conditions that, in the investigator's opinion, may elevate subject risk or confound trial outcomes.\n\n      Specific Exclusion Criteria Relapsed\u002FRefractory Rheumatoid Arthritis (RA)\n  19. ACR functional class Grade 4 for rheumatoid arthritis. Dermatomyositis (DM)\n  20. Paraneoplastic myositis, defined as myositis diagnosed within 2 years following cancer diagnosis, or subjects categorized as high-risk for malignancy.\n  21. Subjects with overlap syndrome (excluding overlap with Sjögren's syndrome), connective tissue disease-associated DM other than primary DM, inclusion body myositis, polymyositis, or drug-induced myopathy.\n  22. Subjects with severe systemic musculoskeletal disorders other than DM, which interfere with adequate investigator assessment of disease activity.\n\n      Systemic Lupus Erythematosus (SLE)\n  23. Renal pathological diagnosis of Class V lupus nephritis (excluding Class III or IV lupus nephritis complicated with Class V lupus nephritis); active nephritis requiring treatment with protocol-prohibited medications, or requirement for hemodialysis.\n\n      Systemic Sclerosis (SSc)\n  24. Concurrent rheumatic autoimmune diseases other than SSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, mixed connective tissue disease, polymyositis and dermatomyositis, as determined by the investigator.Note: Subjects with fibromyalgia, secondary Sjögren's syndrome, and scleroderma-associated myopathy at screening will not be excluded.\n  25. Non-SSc cutaneous lesions that impair accurate investigator evaluation of disease activity.\n  26. History of scleroderma renal crisis occurring within 2 years prior to screening visit.",{"count":685,"type":22},72,[403],"A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19\u002FBCMA-UCAR-T cells in patients with autoimmune diseases.\n\n36-72 patients are planned to be enrolled in the dose-escalation trial.",[128,301,508,28],"2026-04-23",{"date":691,"type":33},"2026-04-30",{"date":693,"type":22},"2026-05-10",{"date":695,"type":22},"2029-01-10",{"name":697,"class":106},"The First Affiliated Hospital with Nanjing Medical University",{"id":699,"slug":700,"hasResults":12,"nctId":701,"briefTitle":702,"officialTitle":702,"acronym":4,"eligibilityCriteria":703,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":704,"targetDuration":4,"studyType":23,"phases":706,"briefSummary":707,"conditions":708,"keywords":710,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":712,"lastUpdatePostDateStruct":713,"startDateStruct":715,"completionDateStruct":717,"leadSponsor":719,"locationsCount":721},"100549464","phase-1-phase-iii-study-of-ad-plureceptor-plus-tafasitamab-cxix-and-lymphodepleting-chemotherapy-in-patients-with-autoimmune-disorders-100549464","NCT06434363","Phase I\u002FII Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders","Inclusion Criteria:\n\nSSc Specific Inclusion Criteria\n\nA. Diagnosis of SSc defined as follows:\n\ni) Fulfilling 2013 American College of Rheumatology (ACR)and European League Against Rheumatism classification (EULAR) criteria for SSc.46 ii) Antinuclear Antibody (ANA) by immunofluorescence positive at titer ≥ 1:80 at screening or prior to screening.\n\nB. SSc disease activity i) Diffuse SSc meeting the following criteria:\n\n(1) Disease duration ≤ 7 years (from onset of first non-Raynaud manifestation) AND (2) mRSS ≥ 15 at screening (Appendix 1) OR ii) Participants diagnosed with diffuse or limited cutaneous SSc AND presence of ILD changes on HRCT AND Disease duration ≤ 7 years (from onset of first non- Raynaud manifestation) AND either (1) or (2)\n\n1. Progressive ILD as defined by Raghu et al47 (≥ 2 of the following):\n\n   (a) worsening respiratory symptoms (b) physiological evidence of disease progression (≥ 1 of the following): (i) Absolute decline in FVC ≥ 5% predicted within 1 year of follow-up (ii) Absolute decline in DLCO (corrected for Hb) ≥ 10% predicted within 1 year of follow-up radiological evidence of disease progression (c) radiological evidence of disease progression (≥ 1 of the following):\n\n   (i) Increased extent or severity of traction bronchiectasis and bronchiolectasis.\n\n   (ii) New ground-glass opacity with traction bronchiectasis (iii) New fine reticulation (iv) Increased extent or increased coarseness of reticular abnormality.\n\n   (v) New or increased honeycombing (vi) Increased lobar volume loss\n2. FVC \\\u003C 80% predicted or extent of ILD changes on HRCT \\> 20%. C. Inadequate response to at least 1 of the following treatments used for at least 3 months: mycophenolate, cyclophosphamide, rituximab, and\u002For tocilizumab\n\nSLE Specific Inclusion Criteria\n\n1. A clinical diagnosis of SLE, based on the 2019 EULAR\u002F ACR classification criteria for adult SLE.\n2. Positive ANA titer ≥1:80 or positive anti-dsDNA antibody at screening or prior to screening.\n3. For LN subjects only: Active, biopsy-proven lupus nephritis (kidney biopsy should have been done within 1 year of study enrollment) class III or IV, with or without the presence of Class V, using the 2018 Revised International Society of Nephrology\u002FRenal Pathology Society criteria48.\n4. Diagnosed with active SLE. Subjects with either LN or without LN will be eligible if they meet the following criteria:\n\n   a. For LN subjects: urine protein-to-creatinine ratio (UPCR) ≥0.5 g\u002Fg on 2 first morning void urine samples during screening despite prior or current treatment with standard of care therapy for at least 12 weeks, including corticosteroids, MMF\u002Fmycophenolic acid (MPA), CY, calcineurin inhibitors, belimumab, and\u002For rituximab. Patients should have failed at least 2 standard of care immunosuppressive therapies tried for 3 months, b. For non-renal SLE subjects: SLEDAI-2K ≥8 and clinical SLEDAI-2K ≥6 (excluding headache, alopecia, mucosal ulcers, fever, and organic brain syndrome) or ≥ 1 major organ system with a BILAG A score (excluding musculoskeletal, mucocutaneous, and\u002For constitutional organ system) during screening despite prior or current treatment with standard of care therapy, including corticosteroids, rituximab or other B cell depleting agents, CY, MMF\u002FMPA, azathioprine, methotrexate, 6-mercaptopurine, sirolimus, tacrolimus, thalidomide, leflunomide, mizorbine, anifrolumab, and\u002For belimumab. Patients should have failed at least 2 standard of care immunosuppressive therapies tried for 3 months, or failed due to intolerance, or unable to obtain medication.\n5. If a subject is currently receiving:\n\n   1. A renin-angiotensin-aldosterone inhibitor, (including direct renin inhibitors, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and mineralocorticoid receptor blockers), the subject must be on a stable dose for at least 8 weeks prior to screening. A sodium-glucose cotransporter-2 (SGLT2) inhibitor, the subject must be on a stable dose for at least 8 weeks prior to screening.\n   2. Regarding oral corticosteroid, doses \\\u003C0.5 mg\u002Fkg prednisone equivalent at the time of enrollment are required. Steroid taper to ≤10 mg prednisone equivalent prior to lymphodepleting chemotherapy is recommended.\n\nChronic GVHD specific inclusion criteria\n\n1. The patient has a history of steroid resistant chronic graft versus host disease (SR- chronic GVHD) or is intolerant of or has unacceptable complications with steroids.\n\n   Definition of SR-chronic GVHD - Chronic GVHD that does not respond adequately to full-dose prednisone. Any of the following conditions would be considered SR-chronic GVHD:\n   * Progressive symptoms \u002F manifestations of chronic GVHD despite receiving prednisone 1 mg\u002Fkg\u002Fday (or equivalent) for two weeks\n   * Stable symptoms \u002F manifestations of chronic GVHD after four to six weeks of prednisone ≥0.5 mg\u002Fkg\u002Fday (or equivalent)\n   * Inability to taper prednisone to \\\u003C0.5 mg\u002Fkg\u002Fday (or equivalent) without worsening of symptoms \u002F manifestations of chronic GVHD\n2. Disease activity:\n\n   • Manifestations\u002Fsymptoms of chronic GVHD rated as moderate to severe on the NIH chronic GVHD global severity score.\n3. Manifestations\u002Fsymptoms of chronic GVHD that have not adequately responded or intolerant to both:\n\n   * Ruxolitinib\n   * Belumosudil.\n4. May be receiving adrenal replacement doses of corticosteroids\n\nInclusion Criteria: For SLE, SSc, and chronic GVHD\n\n1. Able to provide informed consent.\n2. Age ≥18 to ≤80 years.\n3. Adequate organ function i) Peripheral blood absolute neutrophil count (ANC) ≥ 1 × 109\u002FL, unless the neutropenia is deemed to be caused by the underlying autoimmune disease.\n\nii) Hemoglobin ≥ 8 g\u002Fdl, unless the anemia is deemed to be caused by the underlying autoimmune disease.\n\niii) Platelet count ≥ 50 × 109\u002FL without platelet transfusion support, unless the thrombocytopenia is deemed to be caused by the underlying autoimmune disease. No clinically significant active bleeding.\n\niv) Aspartate aminotransferase (AST) \u002F alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN) and total bilirubin ≤ 3 × ULN (or direct bilirubin ≤ 3 × ULN with documented Gilbert's syndrome).\n\nv) Oxygen saturation (SaO2) ≥ 92% on room air (as measured by forehead probes in SSc patients).\n\nvi) Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 45% as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.\n\nvii) Adequate renal function, defined as serum creatinine ≤ 2x ULN and estimated Glomerular Filtration Rate (eGFR using the CKD-EPI equation) ≥ 30 ml\u002Fmin\u002F1.73 m2 5. Recovery to ≤ Grade 1 or baseline of any non-hematological toxicities due to prior therapy.\n\n6\\. Negative pregnancy test in WOCBP. 7. All participants who are able to have children must practice effective birth control while on study and up to 3 months post completion of therapy. Acceptable forms of birth control for female patients include hormonal birth control, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence, for the length of the study. If the participant is a female and becomes pregnant or suspects pregnancy, she must immediately notify her doctor. If the participant becomes pregnant during this study, she will be taken off this study. Men who are able to have children must use effective birth control while on the study. If the male participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor. Participant is willing and able to adhere to the study visit schedule and other protocol requirements and willing to sign informed consent.\n\nExclusion Criteria:\n\nSSc specific exclusion criteria\n\n1. SSc related pulmonary arterial hypertension (PAH) requiring active treatment.\n2. Rapidly progressive SSc related lower GI (small and large intestines) involvement (requiring parenteral nutrition); active gastric antral vascular ectasia.\n3. Prior scleroderma renal crisis.\n4. Severe pulmonary dysfunction with a hemoglobin corrected DLC0 \\\u003C 40% or FVC \\\u003C 40% of predicted or O2 saturation \\\u003C 92% at rest without supplemental oxygen as measured by forehead oxygen pulse oximetry.\n\n   SLE specific Exclusion Criteria\n\n   Subjects are excluded from the study if any of the following criteria apply:\n5. For LN subjects only: Evidence of severe chronicity on kidney biopsy, defined as a modified National Institute of Health chronicity index score of 3+ for any of the following\n\n   individual biopsy features: total glomerulosclerosis score, fibrous crescents, tubular atrophy, or interstitial fibrosis.\n6. The presence of biopsy-proven kidney disease other than active lupus nephritis\n7. Severe pulmonary dysfunction with a hemoglobin corrected DLC0 \\\u003C 40% or FVC \\\u003C 40% of predicted or O2 saturation \\\u003C 92% at rest without supplemental oxygen as measured by forehead oxygen pulse oximetry.Active, severe cardiac manifestations of SLE, including constrictive pericarditis, hemodynamically significant pericardial effusions, and myocarditis at the time of screening.\n\n   Exclusion Criteria for Chronic GVHD\n8. Treatment with any immunosuppressive drug (except steroids) within 5 half lives prior to administration of lymphodepleting therapy.\n\n   Immunosuppressive Drug Five Half Lives Half Life of the Drug Axatilimab 23 days 108 hours Belumosudil 4 days 19 hours Cyclophosphamide 3 days 3-12 hours Ibrutinib 2 days 4-6 hours Ruxolitinib 2 days 5.8 hours Sirolimus 13 days 62 hours Tacrolimus 8 days 2.1-36 hours Tocilizumab 9 weeks 5-13 days\n9. Receiving any immunosuppressive medications that are not being used for management of chronic GVHD.\n10. Treatment with steroids ≥0.5 mg\u002Fkg prednisone daily or equivalent at the time of enrollment and \\>10 mg prednisone daily or equivalent at the time of lymphodepletion.\n11. Received rituximab within 6 months of lymphodepletion.\n\n    Exclusion Criteria for SLE, SSc, and chronic GVHD\n\n    Subjects are excluded from the study if any of the following medical conditions apply:\n12. Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the Investigator; or unwillingness or inability to follow the procedures required in the protocol.\n13. Active, clinically significant central nervous system pathology\n14. Prior history of malignancies or lymphoproliferative disease, following are allowed: Basal or squamous cell carcinoma of the skin, Carcinoma in situ of the cervix or breast or Smoldering Myeloma. History of malignancy that has been treated with a curative intent and is in remission may be allowed after discussion with PI.\n15. Active hepatitis C, active syphilis, any human immunodeficiency virus (HIV), human lymphocytic T-cell virus type 1 and\u002For type 2 (HTLV-1 and\u002For HTLV-2\n16. Uncontrolled systemic fungal, bacterial, viral, or other infection despite appropriate anti- infective treatment at screening or within 72 hours before LD chemotherapy, or 5 days before AD-PluReceptor administration.\n17. History of any one of the following cardiovascular conditions within the 6 months prior to screening: Class III or IV heart failure as defined by the New York Heart Association, myocardial infarction, unstable angina, or other clinically significant cardiac disease.\n18. Prior CAR T cell therapy, genetically modified T cell therapy.\n19. Treatment with cyclophosphamide within 3 days, tocilizumab within 9 weeks, and\u002For any other immunosuppressive drug (excluding steroids) within 5 half-lives prior to administration of lymphodepleting chemotherapy. Immunosuppressive medications are allowed if not being used for management of SLE, LN or SSc.\n20. Treatment with mycophenolate mofetil within 4 days prior to administration of lymphodepleting chemotherapy. For patients who will receive tafasitamab alone may continue mycophenolate mofetil throughout the study.\n21. History of anaphylactic or severe systemic reaction to FLU, CY, Tafasitamab, or any of their metabolites.\n22. Uncontrolled infection at screening.\n23. Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal (on TPN), pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections.\n24. Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures.",{"count":705,"type":22},47,[167,53],"The goal of Safety Lead-In is to confirm the safety of tafasitamab when given to patients with SSc, SLE, and LN.\n\nThe goal of Phase 1 is to find the recommended dose of AD-PluReceptor-NK cells in combination with tafasitamab and lymphodepleting chemotherapy that can be given to patients with the disease.\n\nThe goal of Phase 2 is to learn if the dose of AD-PluReceptor-NK cells found in Phase 1 in combination with tafasitamab and lymphodepleting chemotherapy can help to control the disease.",[709,28,508,125,172],"Autoimmune Disorders",[711],"CAR NK, CAR, Natural Killer, SSc, SLE, LN, GVHD, Chronic GVHD","2026-04-10",{"date":714,"type":33},"2026-04-15",{"date":716,"type":33},"2024-07-31",{"date":718,"type":22},"2030-12-31",{"name":720,"class":106},"M.D. Anderson Cancer Center",2]