[{"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":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,70,0,25,[9,49,79,109,135,157,179,222,246,269,301,327,364,398,420,444,471,497,531,550,573,603,627,648,668],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100053518","early-phase-1-hyaluronidase-for-sclerodactyly-in-systemic-sclerosis-trial-100053518",false,"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","ALL","18 Years","60 Years",{"count":22,"type":23},10,"ESTIMATED","INTERVENTIONAL",[26],"EARLY_PHASE1","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.",[29,30],"Systemic Sclerosis","Sclerodactyly",[32,33,34,35],"Hyaluronidase","Digital fibrosis","Hand function","Autoimmune disease","NOT_YET_RECRUITING","2026-07-08",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":23},"2026-09-01",{"date":44,"type":23},"2027-11",{"name":46,"class":47},"Medical University of South Carolina","OTHER",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":48},"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",true,{"count":59,"type":23},500,"OBSERVATIONAL","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.",[63,64,29,65],"Rheumatoid Arthritis","Systemic Lupus Erythematosus","Healthy Adult Volunteers",[35,67,68],"multi-omic profiling","immunology","RECRUITING","2026-06-26",{"date":72,"type":40},"2026-06-30",{"date":74,"type":40},"2026-06-23",{"date":76,"type":23},"2034-06-23",{"name":78,"class":47},"University Hospital, Montpellier",{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":24,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":108},"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.","75 Years",{"count":89,"type":23},27,[91],"PHASE1","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).",[29,94,63],"Idiopathic Inflammatory Myopathies",[29,94,63,96,97,98],"CAR-T","BCMA","CD19",{"date":100,"type":40},"2026-06-29",{"date":102,"type":40},"2026-01-09",{"date":104,"type":23},"2028-02-22",{"name":106,"class":107},"AstraZeneca","INDUSTRY",18,{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":24,"phases":118,"briefSummary":119,"conditions":120,"keywords":125,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":48},"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.","70 Years",{"count":108,"type":23},[91],"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",[121,122,123,64,29,124],"Multiple Sclerosis (MS)","Myasthenia Gravis (MG)","Neuromyelitis Optica Spectrum Disorder","Immune-Mediated Necrotizing Myopathy",[126],"CD20\u002FBCMA-directed CAR-T cells","2026-06-24",{"date":72,"type":40},{"date":130,"type":23},"2026-07",{"date":132,"type":23},"2028-10",{"name":134,"class":47},"The Affiliated Hospital of Qingdao University",{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":143,"targetDuration":145,"studyType":60,"phases":4,"briefSummary":146,"conditions":147,"keywords":148,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":48},"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":144,"type":23},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.",[29],[29,149],"Patient library",{"date":70,"type":40},{"date":152,"type":40},"2022-10-13",{"date":154,"type":23},"2032-10-13",{"name":156,"class":47},"University Hospital, Brest",{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":24,"phases":167,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":178},"100631162","phase-3-a-study-to-test-whether-nerandomilast-helps-people-with-systemic-sclerosis-100631162","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.",{"count":166,"type":23},448,[168],"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.",[29],{"date":127,"type":40},{"date":173,"type":23},"2026-06-22",{"date":175,"type":23},"2030-03-17",{"name":177,"class":107},"Boehringer Ingelheim",233,{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":187,"enrollmentInfo":188,"targetDuration":4,"studyType":24,"phases":190,"briefSummary":191,"conditions":192,"keywords":195,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":221},"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 70 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 (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 (in addition to hydroxychloroquine \\[HCQ\\]).\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).\n3. Prior treatment with CD19 or CD70 targeted therapy or any prior engineered cell therapy (e.g., CAR T therapy).\n4. Clinically significant or unstable or uncontrolled acute or chronic disease (e.g., hypothyroidism and diabetes) not due to SLE\u002FIIM\u002FSSc.\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 enrollment.\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: 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 or expected need for renal replacement therapy within the next 12 months, 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 IIM classification, 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.","69 Years",{"count":189,"type":23},66,[91],"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).",[193,194,29],"Systemic Lupus Erythematosus (With and Without Nephritis)","Idiopathic Inflammatory Myopathy",[196,197,198,199,200,201,202,203,204,205,206,207,35,208,209,98,210,211],"Systemic lupus erythematosus","SLE","Lupus nephritis","LN","Idiopathic inflammatory myopathy","IIM","Myositis","Dermatomyositis","Anti-synthetase syndrome","Systemic sclerosis","Scleroderma","SSc","CAR T","Allogeneic CAR T","CD70","AlloCAR T","2026-06-17",{"date":214,"type":40},"2026-06-18",{"date":216,"type":40},"2025-11-13",{"date":218,"type":23},"2032-10",{"name":220,"class":107},"Allogene Therapeutics",14,{"id":223,"slug":224,"hasResults":12,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":12,"sex":18,"minAge":230,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":24,"phases":233,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":245},"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":232,"type":23},92,[168],"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",[29],"2026-06-12",{"date":238,"type":40},"2026-06-15",{"date":240,"type":23},"2026-08-29",{"date":242,"type":23},"2030-11-11",{"name":244,"class":107},"Juno Therapeutics, Inc., a Bristol-Myers Squibb Company",56,{"id":247,"slug":248,"hasResults":12,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":57,"sex":18,"minAge":19,"maxAge":87,"enrollmentInfo":253,"targetDuration":4,"studyType":24,"phases":255,"briefSummary":256,"conditions":257,"keywords":259,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"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":254,"type":23},63,[91],"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).",[63,64,29,258],"Sjögren's Disease",[35],"2026-06-11",{"date":262,"type":40},"2026-06-16",{"date":264,"type":23},"2026-09-15",{"date":266,"type":23},"2028-11-20",{"name":268,"class":107},"Otsuka Pharmaceutical Development & Commercialization, Inc.",{"id":270,"slug":271,"hasResults":12,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":116,"enrollmentInfo":276,"targetDuration":4,"studyType":24,"phases":278,"briefSummary":279,"conditions":280,"keywords":286,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":294,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":221},"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.",{"count":277,"type":23},80,[91],"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).",[281,282,283,29,284,202,285],"SLE (Systemic Lupus)","Lupus Erythematosus, Systemic","Lupus Nephritis","Inflammatory Myopathy, Idiopathic","Diffuse Cutaneous Systemic Sclerosis",[208,287,197,283,288,98,289,206,202,205,194,290,291,292,293],"Lupus","Allogeneic","Cell Therapy","Inflammatory Myopathy","Diffused Cutaneous Systemic Sclerosis","Gene Therapy","Autoimmune",{"date":238,"type":40},{"date":296,"type":40},"2025-03-10",{"date":298,"type":23},"2031-12-31",{"name":300,"class":107},"CRISPR Therapeutics",{"id":302,"slug":303,"hasResults":12,"nctId":304,"briefTitle":305,"officialTitle":305,"acronym":306,"eligibilityCriteria":307,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":308,"targetDuration":4,"studyType":24,"phases":310,"briefSummary":312,"conditions":313,"keywords":317,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":323,"leadSponsor":325,"locationsCount":48},"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":309,"type":23},60,[311],"NA","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.",[29,314,315,316],"Face","Facial Involvement","Rehabilitation",[314,318,316,205],"Facial involvement","2026-06-05",{"date":321,"type":40},"2026-06-08",{"date":152,"type":40},{"date":324,"type":23},"2029-12",{"name":326,"class":47},"University Hospital, Strasbourg, France",{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":336,"conditions":337,"keywords":347,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":48},"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":335,"type":23},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.",[338,339,340,29,64,94,63,341,342,343,344,345,346],"Myocarditis","ANCA Associated Vasculitis","Pericarditis","Spondylarthritis","Behcet Disease","Takayasu Arteritis","Sarcoidosis","Still Disease","Tako Tsubo Cardiomyopathy",[348,349,350,351,352,353,354,355],"Cardiovascular disease","Auto-immune disease","Auto-inflammatory disease","Rheumatic disease","CMR","PET","multimodality imaging","ICARD","2026-06-03",{"date":319,"type":40},{"date":359,"type":40},"2025-11-19",{"date":361,"type":23},"2028-10-30",{"name":363,"class":47},"Assistance Publique - Hôpitaux de Paris",{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":4,"eligibilityCriteria":370,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":87,"enrollmentInfo":371,"targetDuration":4,"studyType":24,"phases":373,"briefSummary":375,"conditions":376,"keywords":378,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":395,"locationsCount":397},"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":372,"type":23},240,[91,374],"PHASE2","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.",[29,94,377,63],"Antineutrophil Cytoplasmic Antibody-Associated Vasculitis",[98,379,288,380,381,382,383,289,384,385,206,202,386,29,94,387,388,63],"CAR","NKX019","Natural Killer Cells","Interleukin-15","IL-15","Immunotherapy","Adoptive cell therapy","AAV","Antineutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis","Ntrust-2","2026-06-02",{"date":391,"type":40},"2026-06-04",{"date":393,"type":40},"2024-11-04",{"date":132,"type":23},{"name":396,"class":107},"Nkarta, Inc.",17,{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":24,"phases":407,"briefSummary":408,"conditions":409,"keywords":410,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":413,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":419},"100506097","phase-1-a-study-of-cc-97540-cd-19-targeted-nex-t-car-t-cells-in-participants-with-severe-refractory-autoimmune-diseases-breakfree-1-100506097","NCT05869955","A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)","A Phase 1, Multicenter, Open-Label Study Of CC-97540 (BMS-986353), CD19-Targeted Nex-T Chimeric Antigen Receptor (CAR) T Cells, in Participants With Severe, Refractory Autoimmune Diseases: Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy, Systemic Sclerosis, or Rheumatoid Arthritis (Breakfree-1)","Inclusion Criteria\n\n\\- Diagnosis of Systemic Lupus Erythematosus (SLE) defined as follows:.\n\ni) Fulfilling the 2019 European League Against Rheumatism (EULAR) \u002F American College of Rheumatology (ACR) classification criteria of SLE.\n\nii) Presence of anti-dsDNA, anti-histone, anti-chromatin, anti-Ro (anti-SS-A), anti-La (anti-SS-B), or anti-Sm antibodies at screening.\n\n\\- SLE disease activity:.\n\ni) Active disease at screening, with recent ≥ 1 major organ system with a BILAG A score (excluding musculoskeletal, mucocutaneous, and\u002For constitutional organ system).\n\nii) Inadequate response to glucocorticoids and to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolic acid or its derivatives, belimumab, azathioprine, anifrolumab, methotrexate, rituximab, obinutuzumab, cyclosporin, tacrolimus or voclosporin.\n\n* Diagnosis of Idiopathic Inflammatory Myopathy (IIM) defined as follows:.\n\n  i) Fulfilling the 2017 EULAR\u002FACR classification criteria for probable or definite IIM.\n\nii) Participant diagnosed with the following IIM subgroups: dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS), and polymyositis (PM).\n\niii) Presence of at least 1 myositis specific antibody (MSA), associated antibody (MAA), or ANA at screening or prior to screening.\n\n* IIM disease activity:.\n\n  i) Severe\u002Fmoderate muscle AND\u002FOR skin involvement.\n\nii) Proof of activity as documented by:.\n\nA. An active myositis-associated rash OR.\n\nB. A recent muscle biopsy OR.\n\nC. An elevated CK \\> 3 times the upper limit of normal OR.\n\nD. Participants diagnosed IIM AND progressive Interstitial Lung Disease (ILD) on high-resolution computed tomography (HRCT)\n\niii) Inadequate response to glucocorticoids and at least 2 of the following treatments used for at least 3 months: azathioprine, methotrexate, cyclosporin A, tacrolimus, MMF, cyclophosphamide, IVIG, JAK inhibitors, and rituximab.\n\n* Diagnosis of Systemic Sclerosis (SSc) defined as follows:.\n\n  i) Fulfilling 2013 EULAR\u002FACR classification criteria for SSc.\n\nii) Antinuclear Antibody (ANA) positive at screening or prior to screening.\n\n\\- SSc disease activity:.\n\ni) Participants diagnosed with diffuse cutaneous SSc OR diffuse or limited cutaneous SSc AND progressive ILD, AND.\n\nii) Inadequate response to at least 1 of the following treatments used for at least 3 months: mycophenolate, cyclophosphamide, rituximab, nintedanib, azathioprine, tocilizumab, or intravenous immunoglobulins (IVIG).\n\n\\- Rheumatoid Arthritis (RA) disease activity:.\n\ni) Minimum of 3 SJC and 3 TJC on a 66\u002F68 joint count (SJC\u002FTJC).\n\nii) OR participants diagnosed with progressive ILD (interstitial lung disease).\n\niii) AND Inadequate disease response or intolerance to at least one conventional synthetic disease-modifying antirheumatic drug (DMARD) and as well as ≥ 2 DMARDs with different mechanisms of action from the categories biologic disease-modifying antirheumatic drug (bDMARDs) or targeted synthetic disease-modifying anti-rheumatic drug (tsDMARD) for a minimum of 3 months.\n\nA. Participants qualifying on progressive ILD may have exhausted the therapies above OR have demonstrated inadequate disease response or intolerance to at least one of the following treatments used for at least 3 months: mycophenolate, tocilizumab, cyclophosphamide, rituximab, azathioprine, nintedinib, pirfenidone.\n\nExclusion Criteria\n\n\\- Diagnosis of drug-induced SLE rather than idiopathic SLE.\n\n\\- Other systemic autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel disease, etc) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not excluded.\n\n* SLE overlap syndromes including, but not limited to, rheumatoid arthritis, scleroderma, and mixed connective tissue disease, are excluded.\n* Present or recent clinically significant CNS pathology, within 12 months.\n* IIM disease activity:.\n\n  i) Other forms of IIM: Inclusion Body Myositis, Amyopathic DM, any form of juvenile myositis.\n\nii) Myositis other than IIM, eg, drug-induced myositis and PM associated with HIV.\n\niii) Participants with severe muscle damage (Physician VAS for muscle damage in Myositis Damage Index \\> 7 cm on a 10 cm scale), permanent weakness due to a non-IIM cause (eg, stroke), or myositis with cardiac involvement.\n\n\\- SSc disease activity:.\n\ni) SSc related PAH requiring active treatment.\n\nii) Rapidly progressive SSc related lower GI (small and large intestines) involvement (requiring parenteral nutrition); active gastric antral vascular ectasia.\n\niii) Prior scleroderma renal crisis.\n\n\\- RA disease activity:.\n\ni) Prior history of or current inflammatory joint disease other than RA.\n\nii) Joint damage and\u002For deformity that may confound the investigator's ability to accurately assess disease activity.\n\n\\- Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":406,"type":23},270,[91],"The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).",[64,194,29,63],[411,412],"CC-97540","BMS-986353",{"date":356,"type":40},{"date":415,"type":40},"2023-09-13",{"date":417,"type":23},"2028-08-29",{"name":244,"class":107},54,{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":57,"sex":18,"minAge":19,"maxAge":87,"enrollmentInfo":427,"targetDuration":4,"studyType":24,"phases":428,"briefSummary":429,"conditions":430,"keywords":432,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":442,"locationsCount":48},"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.",{"count":309,"type":23},[91],"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.",[431,94,29,258],"Healthy",[433,202,206,434,201,435,207],"Myopathy","Autoimmune Diseases","SjD","2026-05-20",{"date":438,"type":40},"2026-05-22",{"date":440,"type":40},"2026-02-24",{"date":132,"type":23},{"name":443,"class":107},"Xencor, Inc.",{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":87,"enrollmentInfo":451,"targetDuration":4,"studyType":24,"phases":453,"briefSummary":454,"conditions":455,"keywords":456,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":22},"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, renal, 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.",{"count":452,"type":23},12,[91,374],"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",[29,206],[457,458,459,460,461],"CABA-201","autoimmune disease","anti-CD19 CAR-T therapy","systemic sclerosis","scleroderma","2026-05-13",{"date":464,"type":40},"2026-05-14",{"date":466,"type":40},"2024-07-02",{"date":468,"type":23},"2029-07",{"name":470,"class":107},"Cabaletta Bio",{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":116,"enrollmentInfo":478,"targetDuration":4,"studyType":24,"phases":480,"briefSummary":481,"conditions":482,"keywords":485,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":496},"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":479,"type":23},30,[26],"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.",[483,29,339,94,484],"SLE - Systemic Lupus Erythematosus","Sjögren Syndrome",[486],"CD19\u002FBCMA CAR-T","2026-05-12",{"date":489,"type":40},"2026-05-19",{"date":491,"type":23},"2026-04-30",{"date":493,"type":23},"2029-04-30",{"name":495,"class":107},"Nanjing Bioheng Biotech Co., Ltd.",2,{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":501,"acronym":502,"eligibilityCriteria":503,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":504,"targetDuration":4,"studyType":24,"phases":506,"briefSummary":507,"conditions":508,"keywords":516,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":48},"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":505,"type":23},2200,[311],"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.",[509,510,511,287,512,513,514,29,515],"Chronic Inflammatory Disease","Angioedema","Severe Asthma","Atopic Dermatitis","Psoriatic Arthritis","Multiple Sclerosis","Behçet Disease",[517,518,519,520,521],"Immune Mediated Inflammatory Diseases (IMIDs)","biomarker","cohort study","quality of life","disease severity","2026-04-28",{"date":524,"type":40},"2026-05-05",{"date":526,"type":40},"2020-07-20",{"date":528,"type":23},"2031-07-21",{"name":530,"class":47},"University Hospital, Lille",{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":535,"acronym":4,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":116,"enrollmentInfo":537,"targetDuration":4,"studyType":24,"phases":539,"briefSummary":540,"conditions":541,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":48},"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":538,"type":23},72,[311],"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.",[63,203,64,29],"2026-04-23",{"date":491,"type":40},{"date":545,"type":23},"2026-05-10",{"date":547,"type":23},"2029-01-10",{"name":549,"class":47},"The First Affiliated Hospital with Nanjing Medical University",{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":554,"acronym":4,"eligibilityCriteria":555,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":556,"targetDuration":4,"studyType":24,"phases":558,"briefSummary":559,"conditions":560,"keywords":562,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":496},"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":557,"type":23},47,[91,374],"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.",[561,29,64,287,283],"Autoimmune Disorders",[563],"CAR NK, CAR, Natural Killer, SSc, SLE, LN, GVHD, Chronic GVHD","2026-04-10",{"date":566,"type":40},"2026-04-15",{"date":568,"type":40},"2024-07-31",{"date":570,"type":23},"2030-12-31",{"name":572,"class":47},"M.D. Anderson Cancer Center",{"id":574,"slug":575,"hasResults":12,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":579,"eligibilityCriteria":580,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":581,"enrollmentInfo":582,"targetDuration":4,"studyType":24,"phases":584,"briefSummary":585,"conditions":586,"keywords":588,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":48},"100538919","phase-3-study-of-the-efficacy-of-nintedanibtocilizumab-in-patients-with-systemic-sclerosis-and-interstitial-lung-disease-100538919","NCT06297096","Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease","Multicentre Clinical Trial Evaluating the Safety and Efficacy of the Combination of Nintedanib+Tocilizumab Compared to Standard Treatment in Patients With Systemic Sclerosis and Interstitial Lung Disease. Analysis With Theranostic Approach","NINTOC-TU","Inclusion Criteria:\n\n1. Men or women aged 18-74 at the date of signing the informed consent.\n2. Written informed consent in accordance with the International Harmonization Guidelines Harmonized Tripartite: Guidelines for Good Clinical Practice (ICH-GCP) and local regulations signed before any study procedure.\n3. Documented diagnosis of systemic sclerosis according to the criteria of the American College of Rheumatology (ACR) and The European Alliance of Associations for Rheumatology (former name - European League Against Rheumatism) - EULAR, meeting the criteria of active disease \\[patients with limited and diffused SSc)\\] and with an overall disease duration of less than or equal to (≤ 72 months).\n4. Patients with interstitial lung disease (ILD) confirmed by HRCT (min. 10% lung involvement).\n5. Evaluation of skin induration with the modified Rodnan skin score (mRSS) from 10 to 45 units inclusive.\n6. Patients treated with conventional drugs such as mycophenolate mofetil, methotrexate; should be on stable doses for ≥ 8 weeks before and including the screening visit (W0).\n7. Patients may be treated with standard therapy, but no new therapy or withdrawal of therapy within 8 weeks before the first screening visit (W0).\n8. Patients taking oral glucocorticosteroids (GCS) should be on a stable dose of ≤ 10 mg\u002Fday prednisone or equivalent for at least 8 weeks before the baseline visit.\n9. Patients of childbearing potential should agree to abstain from sexual activity or use a highly effective method of contraception throughout the study and for at least 3 months after the last dose of medicinal products.\n\nExclusion Criteria:\n\n1. Patients not fully capable of giving informed consent.\n2. Pregnant or breastfeeding women.\n3. Major surgery within 8 weeks before screening (W0A).\n4. Rheumatic disease other than systemic sclerosis (systemic lupus erythematosus, rheumatoid arthritis, mixed connective tissue disease). Diagnosis of secondary Sjögren's syndrome is acceptable.\n5. Active diverticulitis and severe enteritis.\n6. Untreated lipid disorders (Initiation of treatment and modification of the lipid profile enable re-screening for examination after 8 weeks from the start of hypolipidemic treatment).\n7. Immunization with a live or attenuated vaccine within 4 weeks before scheduled treatment.\n8. Known hypersensitivity to human, humanized or murine monoclonal antibodies and hypersensitivity to peanut, soya.\n9. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels greater than 1.5 times the upper limit of normal (ULN). If normalized, the patient may be considered for re-screening.\n10. Bilirubin \\>1.5 x ULN.\n11. Creatinine clearance \\\u003C30 ml\u002Fmin.\n12. Significant pulmonary hypertension (PH).\n13. Airway obstruction (forced expiratory volume before bronchodilation in 1 second (FEV1)\u002FFVC \\\u003C0.7) and other clinically significant pulmonary abnormalities.\n14. Cardiovascular diseases with heart failure NYHA III\u002FIV.\n15. More than 4 digital ulcers or a history of severe digital necrosis requiring hospitalization or severe other digital ulcers.\n16. Bleeding risk (such as bleeding tendency, fibrinolysis, full dose of anticoagulants, high dose of antiplatelet therapy, history of central nervous system (CNS) bleeding events in the last year. (INR) \\>2, prothrombin time (PT) and partial thromboplastin (PTT) \\> 1.5 x ULN) and history of a thrombotic event within the last year, history of thrombosis still requiring full therapeutic anticoagulant therapy, fibrinolysis or high-dose antiplatelet therapy \\> 150 mg ASA per day.\n17. History of stroke, or myocardial infarction within 6 months before screening.\n18. Prior treatment with pirfenidone or nintedanib if a minimum of 6 months had not been completed before enrolling the patient in the NINTOC-TU study.\n19. Plasmapheresis and\u002For plasma exchange within the last 12 weeks before screening and use of immunoglobulins within the last 12 weeks and treatment with tocilizumab, treatments targeting B cell depletion, biologics (e.g. tumor necrosis factor antagonists), tyrosine kinase inhibitors, current treatment with alkylating agents (chlorambucil), autologous bone marrow transplantation, thalidomide, antithymocyte globulin, extracorporeal photopheresis.\n20. Treatment with prednisone \\>10 mg\u002Fday, azathioprine, hydroxychloroquine, colchicine, D-penicillamine, sulfasalazine if within 8 weeks before W0. Cyclophosphamide within \\\u003C 8 weeks of randomization visit (W 1). Rituximab within 6 months of visit (randomization W1).\n21. Unstable (fluctuating) background therapy with mycophenolate mofetil or methotrexate in the last 8 weeks.\n22. Patients with chronic liver disease (Child-Pugh A, B, C hepatic impairment).\n23. Active or significant history of infection, including treatment with intravenous antibiotics within the last 4 weeks or oral antibiotics within 2 weeks before screening. Including active confirmed tuberculosis or latent tuberculosis without chemoprophylaxis following applicable local recommendations. Active infection with HBV, HCV, Herpes-Zoster virus in the last 12 months. Human Immunodeficiency Virus (HIV) infection.\n24. A positive result of the SARS-CoV-2 PCR test during the \"0\" visit is an exclusion criterion, while a history of infection more than 4 weeks before the screening tests and confirmed by a negative SARS-CoV-2 PCR test is not an exclusion criterion.\n25. Active or history of malignancy, except for excised\u002Fcured local basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ.\n26. Active or past drug or alcohol abuse.\n27. The inability to understand and comply with the requirements of the protocol (lack of compliance) excludes from participation in the study.","74 Years",{"count":583,"type":23},86,[168],"The study includes adult patients with systemic sclerosis (SSc) with interstitial lung disease (ILD) to evaluate the efficacy and safety of nintedanib plus tocilizumab combination therapy compared to standard therapy (methotrexate, mycophenolate mofetil) for 56 weeks.",[29,587],"Interstitial Lung Disease",[460,589,590,591,592],"ILD","tocilizumab","nintedanib","combination therapy","2026-04-07",{"date":595,"type":40},"2026-04-08",{"date":597,"type":40},"2025-07-01",{"date":599,"type":23},"2028-03-30",{"name":601,"class":602},"National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland","NETWORK",{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":4,"eligibilityCriteria":609,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":610,"targetDuration":4,"studyType":24,"phases":612,"briefSummary":613,"conditions":614,"keywords":615,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":617,"lastUpdatePostDateStruct":618,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":624,"locationsCount":626},"100596609","phase-2-a-study-of-nemolizumab-for-the-treatment-of-adults-with-systemic-sclerosis-100596609","NCT07047690","A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis","A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study of Nemolizumab in Adult Patients With Systemic Sclerosis","Inclusion Criteria:\n\n1. Participant must be 18 years of age or older, at the time of signing the Informed Consent Form.\n2. Classification of systemic sclerosis (SSc) as defined by the 2013 American College of Rheumatology \\[ACR\\]\u002FEuropean League Against Rheumatism \\[EULAR\\] criteria.\n3. Modified Rodnan Skin Score.\n\n   1. Diffuse cutaneous systemic sclerosis (DcSSc) participants and modified Rodnan Skin Score (mRSS) of greater than equal to (\\>=)12 and less than (\\\u003C)30 at both screening and baseline\n   2. Limited cutaneous systemic sclerosis (LcSSc) participants with mRSS \\>=8 at both screening and baseline. LcSSc participants with positive anti-centromere at screening are excluded.\n4. Disease duration in DcSSc participants \\\u003C= 5 years from screening and LcSSc participants \\\u003C=2 years from screening is defined as the time from the first non-Raynaud's phenomenon manifestation of SSc.\n5. Participants are permitted to receive the following background therapies stable for at least 3 months prior to baseline, including any combination of the following:\n\n   1. Nintedanib (\\\u003C150mg twice daily) and\u002For\n   2. One of the following:\n\n      1. Methotrexate (MTX) (\\\u003C25mg weekly) or\n      2. Mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or mycophenolic acid (MPA) (\\\u003C3000mg daily MMF, \\\u003C2160mg daily for MPS or MPA) NOTE: MTX should not be used in combination with MMF\u002FMPS\u002FMPA\n6. Participants with evidence for active or progressive disease.\n7. Men (whose female partner can become pregnant) and women of childbearing potential will be required to use effective means of contraception or commit to true abstinence, when this is in line with preferred and usual lifestyle of the participant, during the study and for at least 12 weeks after receiving the last study treatment.\n8. Female participants of non-childbearing potential\n9. Signed informed consent\n\nExclusion Criteria:\n\n1. Anti-centromere antibody positive at screening for participants with LcSSc.\n2. Anti-RNA polymerase 3 antibody positive for participants with a disease duration \\>18months.\n3. Creatinine clearance \\\u003C30 milli liter per minute \\[ml\u002Fmin\\] (calculated by Cockcroft-Gault formula).\n4. Positive serology results (hepatitis B surface antigen \\[HBsAg\\] or hepatitis B core antibody \\[HbcAb\\], hepatitis C \\[HCV\\] antibody with positive confirmatory test for hepatitis C virus \\[HCV\\] antibody with positive HCV RNA, or human immunodeficiency virus \\[HIV\\] antibody).\n5. FVC \\\u003C50% of predicted normal value, and DLCO \\\u003C40% of predicted normal value (corrected for Hb) at screening and baseline.\n6. Known diagnosis of clinically significant respiratory disorders other than ILD, including severe chronic obstructive pulmonary disease, severe asthma, recent (within 3 months) severe respiratory infections or history of recurrent respiratory infections, smoking, and any other respiratory condition that, in the opinion of the investigator, could interfere with the study or pose a risk to the participant.\n7. Currently listed and\u002For anticipated to be listed for lung transplantation within the next 12 months.\n8. Cardiovascular disease with clinically significant arrhythmia requiring therapy, congestive heart failure (New York Heart Association Class III-IV functional capacity), unstable angina, uncontrolled hypertension, Cor pulmonale, or symptomatic pericardial effusion.\n9. History of myocardial infarction in the last 6 months prior to screening.\n10. Pulmonary hypertension WHO Functional Class III or higher (as defined by WHO 2009) requiring treatment.\n11. Clinical signs of severe malabsorption in the opinion of the investigator or needing parenteral nutrition.\n12. History of scleroderma renal crisis (SRC) 6 months prior to screening.\n13. Participants with underlying chronic liver disease (Child Pugh A, B, C hepatic impairment).\n14. Body weight of \\\u003C30.0 kilogram (Kg) at screening or BL\n15. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed, or unwilling to use appropriate contraception measures during the study period\n16. Previous treatment with nemolizumab\n17. Participants with the primary diagnosis of a rheumatic autoimmune disease other than SSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, polymyositis, dermatomyositis, systemic vasculitis, Sjogren's syndrome, anti-synthetase syndrome, or mixed CTD, as determined by the investigator with consultation of the medical monitors\n18. Systemic sclerosis-like illness including but not limited to localized scleroderma (morphea), eosinophilic fasciitis, sclerodermoid graft-versus-host disease, fibro mucinous conditions (scleredema, scleromyxedema), scleroderma-like conditions that are associated with environmental chemical and drug exposure (e.g., toxic rapeseed oil, vinyl chloride, bleomycin, gadolinium-based contrast agents \\[nephrogenic systemic fibrosis\\], or due to metabolic disease)\n19. History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, e.g., monoclonal antibody) or to any of the study treatment excipient\n20. Known active bacterial, viral, fungal, or any major episode of infection requiring hospitalization or treatment with IV antibiotics or antivirals within 4 weeks prior to screening, or oral antibiotics within 2 weeks prior to screening. Participants may be rescreened once the infection has resolved.\n21. History of a primary immunodeficiency\n22. History of Bone Morrow Transplantation. Chimeric Antigen Receptor (CAR)-T Cell Therapy or any other genetically engineering cells\n23. History of lymphoproliferative disease or history of malignancy of any organ system within the last 5 years, except for (1) basal cell carcinoma, squamous cell carcinoma in situ (Bowen's disease), or carcinomas in situ of the cervix that have been treated and have no evidence of recurrence in the last 12 weeks before the BL visit, or (2) actinic keratoses that have been treated\n24. History of alcohol or substance abuse dependence or any condition that, in the investigator's opinion makes the participant unreliable to following instructions and complete the study\n25. In the opinion of the investigator, the participant has any medical condition, including clinically significant pulmonary abnormalities, or psychological condition,or clinically significant laboratory abnormalities that could pose undue risk to the participant, prevent study completion or adversely affect the validity or interpretability of the study measurements or interfere with the study assessments, or impede the participant's ability to complete the study.\n26. Participant has not adhered to the restrictions in select treatments prior to screening or is not expected to be compliant with restrictions during the study",{"count":611,"type":23},162,[374],"The main purpose of the study is to investigate the efficacy on cutaneous thickness and the safety of Nemolizumab in adult patients with systemic sclerosis after a 52-week treatment period and to select the optimal dose for this target population.",[29],[616,285,587],"Limited Cutaneous Systemic Sclerosis","2026-03-26",{"date":619,"type":40},"2026-03-31",{"date":621,"type":40},"2026-02-20",{"date":623,"type":23},"2028-07-23",{"name":625,"class":107},"Galderma R&D",3,{"id":628,"slug":629,"hasResults":12,"nctId":630,"briefTitle":631,"officialTitle":632,"acronym":4,"eligibilityCriteria":633,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":634,"enrollmentInfo":635,"targetDuration":4,"studyType":24,"phases":636,"briefSummary":637,"conditions":638,"keywords":639,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":641,"startDateStruct":643,"completionDateStruct":645,"leadSponsor":646,"locationsCount":48},"100350534","phase-2-belimumab-and-rituximab-combination-therapy-for-the-treatment-of-diffuse-cutaneous-systemic-sclerosis-100350534","NCT03844061","Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis","A Randomized, Double-Blind, Placebo-Controlled Study of Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis","Inclusion Criteria:\n\n1. Age greater than or equal to eighteen years and less than or equal to 80.\n2. Classification of systemic sclerosis (SSc), as defined using the 2013 American College of Rheumatology\u002FEuropean Union League Against Rheumatism classification of SSc.\n3. Diagnosis of dcSSc, as defined by LeRoy and Medsger.\n4. Disease duration of less than or equal to 3 years as defined by the date of onset of the first non-Raynaud's symptom.\n5. A modified Rodnan Skin Score (mRSS) of \\> 14\n\nExclusion Criteria:\n\n1. Inability to render informed consent in accordance with institutional guidelines.\n2. Disease duration of greater than 3 years.\n3. Patients with mixed connective tissue disease or \"overlap\" unless the dominant features of the illness are diffuse systemic sclerosis.\n4. Limited scleroderma.\n5. Systemic sclerosis-like illness associated with environmental or ingested agents such as toxic rapeseed oil, vinyl chloride, or bleomycin.\n6. The use of other anti-fibrotic agents including colchicine, D-penicillamine, or tyrosine kinase inhibitors (nilotinib, imatinib, dasatinib) in the month prior to enrollment.\n7. Use in the prior month of corticosteroids at doses exceeding the equivalent of prednisone 10 mg daily. Use of corticosteroid at \\\u003C 10 mg of prednisone can continue during the course of the study.\n8. Concurrent serious medical condition which in the opinion of the investigator makes the patient inappropriate for this study such as uncontrollable CHF, arrhythmia, severe pulmonary or systemic hypertension, severe GI involvement, hepatic impairment, serum creatinine of greater than 2.0, active infection, severe diabetes, unstable atherosclerotic cardiovascular disease, malignancy, HIV, or severe peripheral vascular disease.\n9. A positive pregnancy test at entry into this study. Men and women with reproductive potential will be required to use effective means of contraception through the course of the study, such as (1) surgical sterilization (such as a tubal ligation or hysterectomy), (2) double-barrier methods (such as a condom and occlusive cap (diaphragm or cervical\u002Fvault caps) plus spermicidal agent (foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository)(3) an intrauterine device (IUD) or intrauterine system (IUS) (4) estrogenic vaginal ring (5) percutaneous contraceptive patches, or (6) implants of levonorgestrel or etonogestrel. Approved hormonal contraceptives (such as birth control pills, patches, implants or injections) may interact with and reduce the effectiveness of MMF so women receiving MMF who are using oral contraceptives for birth control should employ an additional method (e.g. barrier method). Contraceptive measures such as Plan B (TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use.\n10. Women not willing to use effective birth control for the duration of the study\n11. Breastfeeding.\n12. Participation in another clinical research study involving the evaluation of another investigational drug within ninety days of entry into this study.\n13. The presence of severe lung disease as defined by a diffusion capacity of less than 30% of predicted or requiring supplemental oxygen and forced vital capacity (FVC) of less than 45% of predicted.\n14. Grade 3 hypogammaglobulinemia\n15. Have a significant IgG deficiency (IgG level \\\u003C 400 mg\u002FdL)\n16. Have an IgA deficiency (IgA level \\\u003C 10 mg\u002FdL)\n17. Have a historically positive HIV test or test positive at screening for HIV\n18. Neutrophils \\\u003C1.5X10E9\u002FL\n19. Hepatitis status:\n\n    1. Serologic evidence of current or past Hepatitis B (HB) infection based on the results of testing for HBsAg and HBcAb as follows:\n\n1\\. Patients positive for HBsAg or HBcAb are excluded b) Positive test for Hepatitis C antibody 20. Known active bacterial, viral, fungal, mycobacterial, or other infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening, or oral antibiotics within 2 weeks prior to screening 21. Infection history:\n\n1. Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria)\n2. Hospitalization for treatment of infection within 60 days of Day 0.\n3. Use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, anti-fungals, or anti-parasitic agents) within 60 days of Day 0 22. Suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes zoster and atypical mycobacteria) 23. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications 24. Prior use of Belimumab, Rituximab, or other B-Cell depleting therapies ever 25. The use of other biologics including TNF inhibitors, abatacept, or tocilizumab within the washout period below for each particular drug:\n\n   Tocilizumab - 1 month for patients on 2mg\u002Fkg or 4 mg\u002Fkg. 2 months for patients on 8mg\u002Fkg.\n\n   Cyclophosphamide (oral or IV) - 3 months. Abatacept - 2.5 months. TNF Inhibitors : Etanercept - 1 mo, Infliximab - 2 mo, Adalimumab - 2.5 mo. Any biologic investigational agent (e.g., abetimus sodium, anti CD40L antibody, BG9588\u002F IDEC 131) - 365 days prior to belimumab.\n\n   Any non-biologic investigational agent - 30 days prior to belimumab.\n\n   26\\. Have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months and\u002For any suicidal ideation in the last 2 months or who in the investigator's judgment, pose a significant suicide risk.\n\n   27\\. Current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Day 0.\n\n   28\\. History of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies 29. Live vaccines within 30 days prior to baseline 30. Have a history of malignant neoplasm within the last 5 years with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the uterine cervix treated locally and with no evidence of metastatic disease for 3 years 31. Have a history of a primary immunodeficiency 32. Have any other clinically significant abnormal laboratory value in the opinion of the investigator 33. Have any intercurrent significant medical or psychiatric illness that the investigator considers would make the candidate unsuitable for the study 34. Non English speakers","80 Years",{"count":479,"type":23},[374],"This is a 52 week, single center, randomized, double-blind, placebo-controlled study.\n\nAfter patients maintain a stable dose of Mycophenolate Mofetil (MMF) for at least 1 month, they will be randomized to treatment with either Belimumab \\& Rituximab or placebo.Patients in both groups will be on background MMF for the entirety of the study. Belimumab will be administered subcutaneously and Rituximab intravenously. Placebo injections and infusions will be of normal saline. Randomization will be done in a 2:1 manner to favor the treatment group. It is hypothesized that that Rituximab and Belimumab combination therapy with Mycophenolate Mofetil background therapy will improve fibrosis in SSc skin when compared to treatment with placebo and Mycophenolate Mofetil in a group of patients with early dcSSc.",[29],[29],"2026-03-25",{"date":642,"type":40},"2026-03-27",{"date":644,"type":40},"2019-07-29",{"date":72,"type":23},{"name":647,"class":47},"Hospital for Special Surgery, New York",{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":652,"acronym":4,"eligibilityCriteria":653,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":116,"enrollmentInfo":654,"targetDuration":4,"studyType":24,"phases":656,"briefSummary":657,"conditions":658,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":660,"lastUpdatePostDateStruct":661,"startDateStruct":663,"completionDateStruct":665,"leadSponsor":667,"locationsCount":48},"100558245","early-phase-1-clinical-study-on-targeted-cd19-or-cd19-bcma-car-t-therapy-for-autoimmune-diseases-100558245","NCT06548607","Clinical Study on Targeted CD19 or CD19-BCMA CAR-T Therapy for Autoimmune Diseases","Inclusion Criteria:\n\n1. The subjects voluntarily participated in the study and signed the informed consent form.\n2. Age ≥18 years old and ≤70 years old, both sexes.\n3. Organ function and laboratory tests:\n\n   1. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN), total bilirubin (TBIL) ≤2×ULN (except Gilbert's syndrome).\n   2. Renal function: creatinine ≤1.5×ULN or creatinine clearance ≥40 ml\u002Fmin.\n   3. Blood routine: neutrophil count ≥1×10\\^9\u002FL, hemoglobin ≥60g\u002FL, platelet count ≥20×10\\^9\u002FL, lymphocyte count \\>0.3×10\\^9\u002FL.\n   4. Coagulation: international normalized ratio (INR) ≤ 1.5×ULN, or prothrombin time (PT) ≤ 1.5×ULN.\n   5. Oxygen saturation (SpO2) ≥92% at rest in room air.\n   6. Left ventricular ejection fraction (LVEF) ≥50% on echocardiography.\n4. Negative serum or urine pregnancy test results in female subjects of childbearing potential at screening.\n5. Women of childbearing potential must agree to use a highly effective method of contraception for at least 28 days before initiation of elution and up to 12 months after CAR-T reinfusion. Men of childbearing potential had to agree to the use of an effective barrier method of contraception from the initiation of lymphoidectomy until 12 months after reinfusion of CAR-T and had to refrain from donating semen or sperm throughout the trial.\n\nSLE Patient Inclusion Criteria:\n\n1. A definitive diagnosis of SLE according to the 2019 European League Against Rheumatism (EULAR) \u002F American College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria.\n2. Positive antinuclear antibodies (ANA) at screening, and\u002For positive anti-double-stranded DNA (anti-dsDNA) antibodies, and\u002For positive anti-Smith antibodies.\n3. A SLEDAI-2K score \\>6 at screening, and a 'clinical' SLEDAI-2K score ≥4.\n\nSSc Patient Inclusion Criteria:\n\n1. Diagnosed with SSc according to the 2013 ACR\u002FEULAR classification criteria.\n2. Diagnosed with diffuse cutaneous SSc at screening, with a disease duration ≤6 years.\n\nAAV Patient Inclusion Criteria:\n\n1. Meeting the diagnostic criteria for ANCA-associated vasculitis established by the 2022 ACR\u002FEULAR, including Microscopic Polyangiitis (MPA), Granulomatosis with Polyangiitis (GPA), and Eosinophilic Granulomatosis with Polyangiitis (EGPA).\n2. Positive testing for ANCA-associated antibodies 3 months before screening or at screening (specifically, positive anti-myeloperoxidase antibodies, MPO-ANCA, or positive anti-proteinase 3 antibodies, PR3-ANCA).\n\nIIM Patients Inclusion Criteria:\n\n1. Diagnosed with IIM according to the 2017 ACR\u002FEULAR classification criteria (including probable or definite diagnosis, i.e., probability ≥55%), including subtypes such as Dermatomyositis (DM), Anti-Synthetase Syndrome (ASS), and Immune-Mediated Necrotizing Myopathy (IMNM).\n2. Patients in the active phase, defined as those with at least 2 of the following six core set measures being abnormal: decreased muscle strength (MMT-8 \\\u003C142), Physician Global Assessment (PhGA, 10cm VAS) ≥2cm, Patient Global Assessment (PtGA, 10cm VAS) ≥2cm, Extramuscular Disease Activity Total Score (assessed using the MDAAT scoring tool) ≥2cm, Health Assessment Questionnaire (HAQ) ≥0.25, and Creatine Kinase (CK) muscle enzyme levels ≥1.5×ULN\n\nSjögren's Syndrome (SS) Patient Inclusion Criteria:\n\n1. Diagnosed with primary Sjögren's Syndrome according to the 2016 ACR\u002FEULAR classification criteria.\n2. Positive for anti-SSA\u002FRo antibodies detected 3 months before screening or at screening.\n3. A score of ≥5 on the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) at screening.\n\nExclusion Criteria:\n\n1. SLE Patients: Those with uncontrolled lupus crisis within the 8 weeks prior to screening, including rapidly progressive lupus nephritis, severe neuropsychiatric lupus, severe hemolytic anemia, severe immune thrombocytopenia, agranulocytosis, severe cardiac damage, severe lupus pneumonia, severe lupus hepatitis, and severe vasculitis, as assessed by the investigator as unsuitable to participate in this study.\n2. IIM Patients: Presence of severe rhabdomyolysis or CK levels ≥120×ULN at screening.\n3. Patients with severe asthma or Chronic Obstructive Pulmonary Disease (COPD) are eligible. Patients with mild or moderate asthma or COPD who are receiving stable treatment can also be enrolled.\n4. There has been an active infection requiring systemic treatment within 2 weeks prior to the urethral irrigation, such as infectious pneumonia, tuberculosis, etc.\n5. Positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive for hepatitis C virus (HCV) antibody with detectable HCV RNA in peripheral blood; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis antibody.\n6. Pregnant or breastfeeding women.\n7. Any condition that, in the investigator's opinion, may affect study participation, pose a safety risk to the patient, or potentially confound the interpretation of study results.",{"count":655,"type":23},20,[26],"This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CD19 or CD19-BCMA CAR-T in patients with active SLE, SSc, AAV, IIM and pSS.",[281,29,339,94,659,434],"Sjogren's Syndrome","2026-03-04",{"date":662,"type":40},"2026-03-06",{"date":664,"type":40},"2024-09-14",{"date":666,"type":23},"2027-12-31",{"name":495,"class":107},{"id":669,"slug":670,"hasResults":12,"nctId":671,"briefTitle":672,"officialTitle":673,"acronym":4,"eligibilityCriteria":674,"healthyVolunteers":12,"sex":18,"minAge":675,"maxAge":676,"enrollmentInfo":677,"targetDuration":4,"studyType":24,"phases":679,"briefSummary":680,"conditions":681,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":684,"lastUpdatePostDateStruct":685,"startDateStruct":687,"completionDateStruct":689,"leadSponsor":690,"locationsCount":48},"100588904","phase-1-umbilical-cord-blood-cd19-bcma-cart-cell-therapy-for-sle-ln-ssc-andpss-pah-100588904","NCT06947473","Umbilical Cord Blood CD19-BCMA CART Cell Therapy for SLE-LN, SSc, andpSS PAH.","Single Center, Open Label, Non Randomized, Single Arm Clinical Study of Cord Blood CD19-BCMA CART Cell Therapy for Refractory Lupus Nephritis (SLE-LN), Systemic Sclerosis (SSc), and Primary Sjogren's Syndrome With Pulmonary Hypertension (pSS PAH)","Inclusion Criteria:\n\n* 1\\. Refractory lupus nephritis (LN):\n\nAccording to the 2019 American College of Rheumatology (ACR) criteria and the 2018 International Society of Nephrology (ISN)\u002FSociety of Nephrology (RPS) criteria (see Appendix 3), confirmed by renal tissue biopsy as active, proliferative lupus nephritis, type III or IV \\[excluding type III (C), IV-S (C), and IV-G (C)\\], or type III\u002FIV combined with type V. Biopsy must be performed within 6 months prior to the screening visit or during the screening period.\n\n1. Male or female patients aged 3-65 years old;\n2. Systemic lupus erythematosus that meets the 2019 American College of Rheumatology (ACR)\u002FEuropean Union of Rheumatology Associations (EULAR) classification criteria (see Annex 5);\n3. The result of the anti nuclear antibody (ANA) test is clearly positive, that is, the ANA titer is ≥ 1:80 (equivalent test result based on Hep-2 immunofluorescence detection method or enzyme immunoassay method), and\u002For at the screening visit, the anti dsDNA serum antibody test is positive (≥ 30 IU\u002FmL based on ELISA detection method) according to the test results of the research center laboratory.\n4. B cell CD19+expression and discontinuation of immunosuppressive agents for more than 1 week;\n5. No severe allergic constitution;\n6. Physical condition score (ECOG) 0-2 points;\n7. Expected survival period ≥ 90 days;\n8. The subjects and\u002For their guardians are able to understand and willing to sign a written informed consent form; 2. Systemic sclerosis (SSc):\n\n\u003C!-- -->\n\n1. The selected patient or their legal representative voluntarily signs the informed consent form.\n2. Age range: 6-65 years old (including 6 and 65 years old), gender is not limited.\n3. According to the SSc classification criteria proposed by the American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) in 2013, the highest score under the same item, ≥ 9 points, can be classified as SSc (Attachment 6).\n4. Or if one sufficient condition is met, that is, the skin of both fingers thickens and extends to the proximal end of the metacarpophalangeal joint, it can be directly classified as SSc.\n\n3\\. Primary Sjogren's syndrome with pulmonary hypertension (pSS PAH):\n\n(1) The selected patients or their legal representatives voluntarily sign informed consent.\n\n(2) Age range: 18-65 years old (including 18 and 65 years old), gender is not limited.\n\n(3) Patients with refractory connective tissue disease (pulmonary arterial hypertension):\n\n1. Diagnosed with primary Sjogren's syndrome according to the 2002 AECG classification criteria or the 2016 ACR\u002FEULAR classification criteria\n2. Confirmed by right heart catheterization to meet the diagnostic criteria for PAH (as defined in the 2022 ESC\u002FERS guidelines for the diagnosis and treatment of pulmonary arterial hypertension):\n\n   * Resting mean pulmonary artery pressure (mPAP) ≥ 20mmHg;\n\n     * Pulmonary artery wedge pressure (PAWP) ≤ 15mmHg;\n\n       ③ Resting pulmonary vascular resistance (PVR)\\>2WU; (4) PAH did not reach the risk stratification of low-risk group patients. Low risk patients need to meet: ① WHO heart function classification I-II; ② 6-minute walking distance (6MWD)\\>440 meters; ③ BNP\\\u003C50ng\u002FL， Or NT proBNP\\\u003C300ng\u002FL; ④ Right atrial pressure (RAP)\\\u003C8mmHg and cardiac index (CI) ≥ 2.5 L · min-1 · m-2.\n\n       (5) Prior to the first administration of the investigational drug, a stable dose of standard treatment was received, including corticosteroids (prednisone 0-30mg\u002Fday, or equivalent other formulations) for at least 4 weeks; Antimalarial drugs and monotherapy immunosuppressants (allowed immunosuppressants are limited to: mycophenolate mofetil or mycophenolate mofetil ≤ 1.5g\u002Fday, azathioprine or 6-mercaptopurine ≤ 2mg\u002Fkg\u002Fday, methotrexate ≤ 15mg\u002Fweek, leflunomide ≤ 20mg\u002Fday) should be used for at least 12 weeks, and should not be increased or replaced within 24 weeks after drug treatment. Prior to drug treatment, use PAH targeted drugs of less than three types (including prostaglandin analogs, endothelin receptor antagonists, PDE-5 inhibitors, and guanylate cyclase agonists), which have been stable for at least 4 weeks and have not been increased or replaced within 24 weeks after drug treatment.\n\n       (6) Clinicians assess the patient's condition and allow the use of corticosteroids at a dose not exceeding 10mg prednisone or its equivalent during the study period, and allow the discontinuation of all immunosuppressants (excluding hydroxychloroquine).\n\n       (7) Women of childbearing age have a negative blood pregnancy test within 7 days prior to the pre-treatment treatment; Any male and female patient with fertility must agree to use an effective contraceptive method throughout the entire study process and for at least one year through the infusion of cell injection. The patient's fertility refers to their biological ability to give birth to live infants and have normal sexual activity. Female patients who are infertile (i.e. meet at least one of the following criteria): have undergone hysterectomy or bilateral oophorectomy, or have been medically confirmed to have ovarian failure, or have been medically confirmed to be postmenopausal (with at least 12 consecutive months of amenorrhea without pathological or physiological reasons).\n\n       (8) Having appropriate organ function, it must meet the following standards: Aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) ≤ 3 times ULN; Total serum bilirubin ≤ 2 times ULN, unless the patient has a record of Gilbert syndrome; Bilirubin ≤ 3.0 times ULN and direct bilirubin Gilbert syndrome patients with hemoglobin ≤ 1.5 times ULN can be included; There must be a minimum level of lung reserve, with oxygen saturation greater than 95% in non oxygenated state.\n\nExclusion Criteria:\n\n* 1\\. Refractory lupus nephritis (LN):\n\n  1\\) Intracranial hypertension or cerebral consciousness disorders; 2) Symptomatic heart failure or severe arrhythmia; 3) Symptoms of severe respiratory failure; 4) Accompanied by other types of malignant tumors; 5) Diffuse intravascular coagulation; 6) Suffering from sepsis or other difficult to control infections; 7) Have uncontrollable diabetes and other endocrine diseases; 8) Serious mental disorder; 9) Head MRI examination shows obvious lesions in the skull; 10) Received organ transplantation (excluding bone marrow transplantation); 11) Female patients (those with fertility) have a positive HCG test in their blood; 12) Hepatitis (including hepatitis B and C), AIDS and syphilis screening positive persons; 13）eGFR CKD-EPI \\\u003C 30 ml\u002Fmin\u002F1.73m\\^2； 14) Any active skin disease that may interfere with the evaluation of systemic lupus erythematosus research,Including but not limited to psoriasis, dermatomyositis, systemic sclerosis, and non systemic diseases Skin manifestations of lupus erythematosus (such as skin vascular disease, pericapillary dilation)Zhang, fingertip sclerosis, rheumatoid nodules, erythema multiforme, leg ulcers)Or drug-induced lupus.\n\n  15\\) Subjects who were not successfully matched during the screening period; 16) Previously received CART treatment other than CD19-CART. 2. Primary Sjogren's syndrome with pulmonary hypertension (pSS PAH):\n\n  1\\) PH caused by other reasons: portal hypertension, hereditary hemorrhagic telangiectasia, etc; Congenital heart disease; Suspicious drugs and toxins; Chronic hypoxic disease-related pulmonary hypertension: moderate or severe obstructive pulmonary disease: FEV1\\\u003C55%； Moderate or severe restrictive lung disease: TLC\\\u003C60%； Chronic thromboembolic disease pulmonary hypertension: Pulmonary ventilation\u002Fperfusion imaging suggests moderate to high suspicion of pulmonary thromboembolism; 2) Suffering from severe active central nervous system (CNS) lupus, including seizures, psychosis, cerebrovascular accidents, or CNS vasculitis requiring therapeutic intervention within 60 days after baseline; 3) Dialysis patients or creatinine clearance rate less than 30mL\u002Fmin; 4) Pregnancy or breastfeeding; 5) Merge active infections (such as sepsis, bacteremia, mycosis, uncontrolled pulmonary infections, and active tuberculosis); 6) Hepatitis B surface antigen (HBsAg) and\u002For hepatitis B e antigen (HBeAg) are positive; Hepatitis B e antibody (HBe Ab) and\u002For hepatitis B core antibody (HBc Ab) are positive, and the number of HBV-DNA copies is greater than the measurable lower limit; Hepatitis C (HCV) antibody positive; Positive for human immunodeficiency virus (HIV) antibodies; Individuals who test positive for syphilis antibody (TP Ab); 7) Having undergone major surgeries evaluated by researchers as unsuitable for inclusion within the previous 4 weeks prior to screening; 8) Subjects who were not successfully matched during the screening period; 9) Previously received CART treatment other than CD19-CART. 3.Systemic sclerosis (SSc)：\n\n  1\\) Overlapping connective tissue diseases; Rheumatoid arthritis, systemic lupus erythematosus, or inflammatory myopathy 2) The clinical manifestations can be explained by similar diseases of SSc, such as nephrogenic systemic fibrosis, generalized scleroplakia, eosinophilic fasciitis, diabetes scleroma, scleromyedema, erythematous acrodynia, porphyria, sclerotic lichen, graft-versus-host disease, diabetes and other endocrine diseases related hand joint diseases.\n\n  3\\) Suffering from severe active central nervous system (CNS) lupus, including seizures, psychosis, cerebrovascular accidents, or CNS vasculitis requiring therapeutic intervention within 60 days after baseline; 4) Dialysis patients or creatinine clearance rate less than 30mL\u002Fmin; 5) Pregnancy or breastfeeding; 6) Merge active infections (such as sepsis, bacteremia, mycosis, uncontrolled pulmonary infections, and active tuberculosis); 7) Hepatitis B surface antigen (HBsAg) and\u002For hepatitis B e antigen (HBeAg) are positive; Hepatitis B e antibody (HBe Ab) and\u002For hepatitis B core antibody (HBc Ab) are positive, and the number of HBV-DNA copies is greater than the measurable lower limit; Hepatitis C (HCV) antibody positive; Positive for human immunodeficiency virus (HIV) antibodies; Individuals who test positive for syphilis antibody (TP Ab); 8) Having undergone major surgeries evaluated by researchers as unsuitable for inclusion within the previous 4 weeks prior to screening; 9) Subjects who were not successfully matched during the screening period; 10) Previously received CART treatment other than CD19-CART.","6 Years","65 Years",{"count":678,"type":23},45,[91,374],"This is a single-center, open-label, non-randomized, single-arm clinical trial. Patients with refractory lupus neritis (SLE-LN), systemic sclerosis (SSc), and primary Sjogren syndrome combined with pulmonary artery hypertension (pSS-PAH receive umbilical cord blood CD19-BCMA CAR T cell therapy. The primary objective is to prospectively assess the safety of umbilical cord blood CD19BCMA CAR T cell therapy in patients with refractory lupus nephritis (SLE-LN), systemic sclerosis (SSc), and primaryjogren syndrome combined with pulmonary artery hypertension. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days after theusion of umbilical cord blood CD19-BCMA CAR T cells. It is anticipated that 45-54 participants will be recruited.",[682,29,683],"Refractory Lupus Nephritis","Primary Sjogren's Syndrome Combined With Pulmonary Hypertension","2026-03-01",{"date":686,"type":40},"2026-03-03",{"date":688,"type":23},"2026-03-18",{"date":666,"type":23},{"name":691,"class":47},"Beijing GoBroad Hospital"]