[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sjogren-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sjogren-syndrome":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,48,86,132,161,194,221,253,275,304,321,344],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100644483","phase-2-safety-and-efficacy-of-topical-infliximab-in-autoimmune-dry-eye-disease-100644483",false,"NCT07671222","Safety and Efficacy of Topical Infliximab in Autoimmune Dry Eye Disease","Safety and Efficacy of Topical Infliximab Versus Topical Steroid in Autoimmune Dry Eye Disease: Randomized Controlled Trial.","INFLIXIDRY","Inclusion Criteria:\n\n* Adult patients (≥ 18 years).\n* Confirmed diagnosis of primary or secondary Sjögren's syndrome according to the 2016 ACR\u002FEULAR classification criteria.\n* On stable systemic immunomodulatory therapy (non-biologic) for at least 12 weeks, with no planned changes during the study (see section 14.1 if there are concerns about confounding variables).\n* Negative chest X-ray or Interferon-Gamma Release Assays (IGRA).\n* Diagnosis of severe dry eye, defined by meeting all of the following criteria in at least one eye at study entry:\n* OSS (SICCA 0-12) ≥ 6 in at least one eye.\n* OSDI ≥ 33 (severe symptoms).\n* Symptoms: OSDI score ≥ 33.\n* Signs: Ocular Staining Score (OSS, SICCA) ≥ 6.\n* Ability to understand and sign informed consent and to comply with study procedures and treatment administration.\n\nExclusion Criteria:\n\n* Current use of topical corticosteroids or topical immunomodulators (cyclosporine, lifitegrast, tacrolimus, autologous serum) within 30 days prior to enrollment.\n* Current or recent use (\\\u003C 3 months) of punctal plugs.\n* Active ocular infection (bacterial, viral, fungal) or recent history of herpetic keratitis.\n* Ocular or eyelid surgery within the past 6 months.\n* Use of contact lenses during the study period.\n* Known allergy or hypersensitivity to infliximab, murine proteins, or any component of the formulation (including CMC).\n* Coexisting ocular conditions that may interfere with dry eye evaluation (e.g., active ocular cicatricial pemphigoid, active ocular graft-versus-host disease, uncontrolled glaucoma, significant corneal dystrophy).\n* Systemic conditions considered contraindications to infliximab exposure, including: active systemic infection, untreated active or latent tuberculosis, history of demyelinating disease, moderate to severe congestive heart failure (NYHA Class III\u002FIV), or history of malignancy within the past 5 years.\n* Use of systemic biologic agents within the past 6 months (12 months for systemic anti-TNF-α therapy).\n* Pregnancy, breastfeeding, or intention to become pregnant during the study.\n* Participation in another clinical trial with an investigational drug within the past 30 days.\n* Ability to understand and sign informed consent and to comply with study procedures and treatment administration.","ALL","18 Years",{"count":20,"type":21},38,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Sjögren's syndrome is a condition in which the immune system attacks the body's moisture-producing glands. This often causes severe dry eye, leading to discomfort, irritation, blurred vision, and damage to the eye surface. Inflammation plays an important role in this process, and a protein called TNF-alpha is one of the key drivers.\n\nThis study will test a new eye drop containing infliximab, a medication that blocks TNF-alpha. The goal is to see whether this treatment can safely improve symptoms and signs of severe dry eye in patients with Sjögren's syndrome.",[27,28,29],"Sjogren Syndrome","Sjogren Syndrome With Keratoconjunctivitis","Dry Eye Disease (DED)",[31,32,33,34],"Dry eye disease","Sjogren syndrome","Sjogren disease","Autoimmune dry eye","NOT_YET_RECRUITING","2026-06-22",{"date":38,"type":39},"2026-06-26","ACTUAL",{"date":41,"type":21},"2026-12",{"date":43,"type":21},"2028-03",{"name":45,"class":46},"Instituto de Oftalmología Fundación Conde de Valenciana","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":85},"100348403","phase-1-testing-an-immunotherapy-anti-cancer-drug-nivolumab-for-advanced-cancers-in-patients-with-autoimmune-disorders-aim-nivo-100348403","NCT03816345","Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO","A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)","Inclusion Criteria:\n\n* Patients can have either histologically confirmed malignancy that is radiologically evaluable and metastatic or unresectable, or have a malignancy for which a PD-1\u002FPD-L1 inhibitor has been approved in the adjuvant setting, as well as the neoadjuvant or perioperative setting in which such treatment is considered standard of care or has been approved. Eligible tumor types include solid tumors and malignancies in which there is known evidence of clinical activity for single agent PD-1 or PD-L1 antibodies. Nivolumab or other PD1\u002FPD-L1 inhibitors are FDA-approved for the treatment of melanoma, non-small cell lung cancer (NSCLC), Merkel cell cancer, bladder cancer, renal cell carcinoma (RCC), gastric cancer, hepatocellular carcinoma (HCC), cervical cancer, head and neck cancer, Hodgkin lymphoma (HL), metastatic small cell lung cancer (SCLC), and any solid tumor with microsatellite instability (MSI)-high status confirmed. Patients with HL are eligible but must follow standard response criteria. Additional tumor types may be eligible on a case by case basis upon discussion with principal investigator (PI)\n\n  * Patients enrolling on the trial for adjuvant use will be restricted to those with histology for which a PD-1\u002FPD-L1 inhibitor has been approved in the adjuvant setting including but not limited to NSCLC, melanoma, RCC, cervical cancer, and bladder cancer\n  * Patients enrolled on the study can receive Nivolumab with other FDA-approved combinations according to the FDA package insert, including, but not limited to ipilimumab, cabozantinib or chemotherapy\n* Patients who have previously received other forms of immunotherapy (high-dose \\[HD\\] IL-2, IFN, CTLA-4) are allowed. Patients must not have received cytokine immunotherapy for at least 4 weeks before nivolumab administration. Patients who have received prior anti-CTLA4 will be allowed and the washout period is 6 weeks\n* Age \\>= 18 years; children are excluded from this study but may be eligible for future pediatric phase 1 combination trials\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Karnofsky \\>= 60)\n* Life expectancy of greater than 12 weeks\n* Leukocytes \\>= 1,000\u002FmcL\n* Absolute neutrophil count \\>= 500\u002FmcL\n* Platelets \\>= 50,000\u002FmcL\n* Total bilirubin =\\\u003C 2 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 5 x institutional ULN or =\\\u003C 8 x institutional ULN for patients with liver metastases or an autoimmune disease that is contributing to the elevation of these values\n* Creatinine ULN OR glomerular filtration rate (GFR) \\>= 30 mL\u002Fmin (if using the Cockcroft-Gault formula)\n* Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy if indicated\n* If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral load\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required for at least 4 weeks (or scheduled assessment after the first cycle of treatment), and a risk-benefit analysis (discussion) by the patient and the investigator favors participation in the clinical trial\n* The effects of nivolumab on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 5 months after the last dose of investigational product. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product\n\n  * Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin \\[HCG\\]) within 24 hours prior to the start of nivolumab. Women must not be breastfeeding. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception\n  * WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy), tubal ligation, or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU\u002FmL\n  * These durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days, and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 days\n  * Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately. Patients can resume treatment upon termination of a pregnancy or the completion of a successful pregnancy\n* Ability to understand and the willingness to sign a written informed consent document\n* Patients with more than one autoimmune disease are eligible. The treating physician would determine which autoimmune disease is dominant and the patient would be treated under that specific cohort (Please note: Patients with more than one autoimmune disease should receive assessments for all previously diagnosed autoimmune diseases. For example, a patient with psoriasis and IBD might be enrolled in the IBD cohort. Disease assessments for both psoriasis and IBD should be obtained, as per protocol. Case report forms \\[CRFs\\] for all relevant autoimmune diseases should be utilized. However, all additional cohort requirements will be considered optional and only the assessments from the assigned cohort will be considered mandatory)\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients with known SSc or DM according to updated classification criteria (Van den Hoogan et al., Arthritis Rheum 2013;65(11):2737-47; Lundberg et al., A\\&R in press). Overlap features are permitted, but patients must meet criteria for a \"primary diagnosis\" of DM or SSc\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients may be on any concurrent therapy for DM or SSc unless specifically excluded\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients must have a baseline computed tomography (CT) of the chest (within 6 months of study entry)\n* RA-SPECIFIC INCLUSION: Rheumatologist-diagnosed RA requiring prior treatment with disease-modifying antirheumatic drugs (DMARDs) before patient was diagnosed with current malignancy. We recommend, but do not require, documentation for meeting 2010 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria for RA\n* RA-SPECIFIC INCLUSION: Prednisone up to 10 mg\u002Fday will be allowed. Intraarticular steroids will be allowed for the treatment of new symptomatic joints\n* RA-SPECIFIC INCLUSION: Nonsteroidal anti-inflammatory drugs (NSAIDs) will be allowed\n* SLE-SPECIFIC INCLUSION: SLE diagnosed by a rheumatologist. The patient should meet the revised 1997 American College of Rheumatology (ACR) classification criteria for SLE, but this is not mandatory\n* ULCERATIVE COLITIS (UC)-SPECIFIC INCLUSION: Diagnosis of UC must be made by endoscopy with biopsies\n* UC-SPECIFIC INCLUSION: Complete colonoscopy with biopsies during study screening, within 8 weeks before initial nivolumab administration, or within 4 weeks after initial nivolumab administration\n* UC-SPECIFIC INCLUSION: Patients must test negative for hepatitis B (antigen \\[Ag\\] negative, antibody \\[core (c)Ab\\] negative, antibody \\[surface (s)Ab\\] positive or negative) and Mycobacterium tuberculosis (purified-protein- derivative \\[PPD\\] or enzyme-linked immunospot assay \\[ELISpot or T-spot\\]) or be on appropriate anti-microbial treatment for these infections\n* UC-SPECIFIC INCLUSION: Mild Disease Cohort: Patients must be in clinical remission, defined as a Mayo Clinic score (MCS) of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 either without medications, or treated with 5-ASA derivative, probiotic, or prior fecal transplant\n* UC-SPECIFIC INCLUSION: Moderate Disease Cohort: Patients must be in clinical remission, defined as a MCS of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 on 6-mercaptopurine, azathioprine, methotrexate, or rectal hydrocortisone, budesonide, or one of these medications in combination with any of the medications listed in the Mild cohort\n* UC-SPECIFIC INCLUSION: Severe Disease Cohort (A or B): Patients must either be A) in clinical remission, defined as a MCS of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 on a biologic therapy targeting tumor necrosis alpha (TNF-α) (infliximab, adalimumab, golimumab), α4β7 integrin (vedolizumab), or one of these biologic therapies in combination with any of the medications listed in the Mild or Moderate cohort, or B) have mild active disease defined as a MCS of 3-5 and no subscore higher than 2, and an endoscopic subscore of \\\u003C 2 on one of the medications or combination of medications defined for the Moderate or Mild cohort\n* CROHN'S DISEASE (CD)-SPECIFIC INCLUSION: Complete colonoscopy with biopsies during study screening, within 8 weeks before initial nivolumab administration, or within 4 weeks after initial nivolumab administration\n* CD-SPECIFIC INCLUSION: If patients have prior known disease in the stomach or small intestines, appropriate endoscopic evaluation (esophagogastroduodenoscopy\u002Fvideo capsule endoscopy) and\u002For imaging (computed tomography or magnetic resonance enterography) must also be current within 4 weeks prior to nivolumab administration\n* CD-SPECIFIC INCLUSION: Deep enteroscopy techniques, such as double balloon enteroscopy, will not be required\n* CD-SPECIFIC INCLUSION: Patients must test negative for hepatitis B (sAg negative, cAb negative, sAb positive or negative) and M. tuberculosis (PPD or ELISpot or T-spot) or be on appropriate anti-microbial treatment for these infections\n* CD-SPECIFIC INCLUSION: Mild Disease Cohort: Patients must be in clinical remission as defined by a Crohn's Disease Activity Index (CDAI) \\\u003C 150 either without treatment or on a 5-ASA derivative, probiotic, antibiotics, or following fecal transplant\n* CD-SPECIFIC INCLUSION: Moderate Disease Cohort: Patients must be in clinical remission as defined by a CDAI \\\u003C 150 on 6-mercaptopurine, azathioprine, methotrexate, rectal hydrocortisone, budesonide, or one of these medications in combination with any of the medications listed in the Mild cohort\n* CD-SPECIFIC INCLUSION: Severe Disease Cohort (A or B): Patients must either A) be in clinical remission as defined by a CDAI \\\u003C 150 on biologic therapy targeting TNF-α (infliximab, adalimumab, certolizumab pegol), IL-12\u002F23p40 (ustekinumab), α4β7 integrin (vedolizumab), or one of these biologic therapies in combination with any of the medications listed in the Mild or Moderate cohort, or B) have mild active disease as defined by a CDAI of 150 to 220 on one of medications or combination of medications defined for the Moderate or Mild cohort\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For other autoimmune diseases that cannot be classified, the eligibility criteria will be determined by the managing rheumatologist or other autoimmune disease specialist, based on the clinical judgement and current American College of Radiology (ACR) classification guidelines or other relevant guidelines, as per the disease category in question\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For giant cell arteritis (GCA), patients must have had positive temporal artery biopsy for GCA and abnormal erythrocyte sedimentation rate (ESR) at time of diagnosis\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For polymyalgia rheumatica (PMR), patients must have clinical diagnosis in addition to elevated inflammatory markers including (ESR, C reactive protein \\[CRP\\])\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: Patients can be in remission (with no glucocorticoids or immunosuppressive medications) or have low-moderate activity, which is defined as being on prednisone ≤ 10 mg or equivalent\n* MS-SPECIFIC INCLUSION: Patients must meet 2017 McDonald criteria for the diagnosis of MS (Thompson AJ, et al. Diagnosis of multiple sclerosis: 2017 revision of the McDonald criteria. Lancet Neurol. 17(2):162-173.)\n* MS-SPECIFIC INCLUSION: Patients with MS can be in remission and can have a history of being on immunomodulatory agents, but at the time of entry into the clinical trial, patients should be off any concurrent MS therapy for at least 2 weeks. Patients receiving concomitant interferon gamma (IFN-γ treatment) will be permitted in the study\n* SJS-SPECIFIC INCLUSION: SjS diagnosed by a rheumatologist or oral medicine provider. The patient should meet the American-European Consensus Criteria for Sjögren's Syndrome (Vitali, et al., 2002). If on treatment, the patient may only be on hydroxychloroquine and prednisone ≤ 10 mg or equivalent\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients with known PsO as diagnosed by a dermatologist or PsA by a rheumatologist and\u002For by Classification for Psoriatic Arthritis (CASPAR) criteria (Tillett et al., 2012)\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients must have stable disease as determined by the investigator with no change in systemic therapy and\u002For biologic therapy for at least 3 months, except for those on tumor necrosis factor (TNF) inhibitors. In the case of TNF inhibition, patients may have transitioned to an alternative biologic therapy with stable disease for at least 4 weeks. For PsA, no change in corticosteroid therapy for at least 1 month prior to baseline and dose must be 10 mg or less\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients may be on any concurrent therapy for PsO or PsA unless specifically excluded\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (AEs) due to agents administered more than 4 weeks earlier have not resolved or stabilized. Palliative (limited-field) radiation therapy (RT) is permitted (2 week washout from start of treatment), if all of the following criteria are met:\n\n  * Repeat imaging demonstrates no new sites of bone metastases\n  * The lesion being considered for palliative radiation is not a target lesion\n* Patients with prior therapy with an anti-PD-1 or anti-PD-L1\n* Patients with prior allogeneic hematologic transplant\n* Patients who are receiving any other anticancer investigational agents\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* UC-SPECIFIC EXCLUSION: Patients who have received ipilimumab treatment\n* UC-SPECIFIC EXCLUSION: Prior colectomy\n* UC-SPECIFIC EXCLUSION: Concurrent primary sclerosing cholangitis (PSC). Patients with PSC can be enrolled on the Other Autoimmune Diseases Cohorts\n* UC-SPECIFIC EXCLUSION: Patients on empiric immunosuppressive treatment without any clinical workup\n* CD-SPECIFIC EXCLUSION: Known untreated abscesses, untreated and symptomatic strictures, short gut physiology, or isolated jejunal disease\n* CD-SPECIFIC EXCLUSION: Patients who have received ipilimumab treatment\n* CD-SPECIFIC EXCLUSION: Patients on empiric immunosuppressive treatment without any clinical workup\n* MS-SPECIFIC EXCLUSION: Patients with MS cannot have medical contraindications to gadolinium-enhanced magnetic resonance imaging (MRI)",{"count":56,"type":21},300,[58],"PHASE1","This phase Ib trial studies the side effects of nivolumab and to see how well it works alone and in combination with other treatments, such as ipilimumab, cabozantinib, platinum containing therapy, and fluoropyrimidine, in treating patients with autoimmune disorders and cancer that has spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced), to other places in the body (metastatic) or cannot removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Cabozantinib is a type of tyrosine kinase inhibitor and a type of angiogenesis inhibitor. Chemotherapy drugs, such as platinum containing therapies and fluoropyrimidine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab alone and in combination with other treatments, including ipilimumab, cabozantinib, platinum containing therapy, or fluoropyrimidine, may be safe, tolerable, and\u002For effective in treating patients with autoimmune disorders and advanced, metastatic, or unresectable cancer.",[61,62,63,64,65,66,67,68,69,70,27,71,72,73],"Autoimmune Disease","Crohn Disease","Dermatomyositis","Hematopoietic and Lymphoid Cell Neoplasm","Inflammatory Bowel Disease","Malignant Solid Neoplasm","Multiple Sclerosis","Psoriasis","Psoriatic Arthritis","Rheumatoid Arthritis","Systemic Lupus Erythematosus","Systemic Scleroderma","Ulcerative Colitis","RECRUITING","2026-06-16",{"date":77,"type":39},"2026-06-17",{"date":79,"type":39},"2019-07-16",{"date":81,"type":21},"2028-03-30",{"name":83,"class":84},"National Cancer Institute (NCI)","NIH",52,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":106,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":85},"100592260","phase-2-allonk-an-allogeneic-non-genetically-modified-cord-blood-derived-nk-cell-therapy-in-combination-with-rituximab-studied-in-relapsing-forms-of-b-cell-dependent-rheumatologic-diseases-100592260","NCT06991114","AlloNK®, an Allogeneic Non-genetically Modified, Cord Blood-derived NK Cell Therapy, in Combination With Rituximab, Studied in Relapsing Forms of B-cell Dependent Rheumatologic Diseases.","An Open-label Phase 2a Study to Evaluate the Safety and Efficacy of AlloNK®, an Allogeneic Cord Blood-derived NK Cell Therapy, in Combination With Rituximab in Relapsing Forms of B-cell Dependent Rheumatologic Diseases","For Subjects with Refractory Rheumatoid Arthritis (RA):\n\n* Documented diagnosis of RA, meeting the 2010 ACR\u002FEULAR classification criteria.\n* Rheumatoid Factor (RF) or Anti Citrullinated Protein Antibody (ACPA) positive.\n* High-sensitivity C-reactive protein (hs-CRP) \\> 3 mg\u002FL or Erythrocyte Sedimentation Rate (ESR) \\> 28 mm\u002Fhr.\n* Have had prior treatment for a period of at least 12 weeks with a biologic disease modifying anti-rheumatic drug and were deemed refractory by the treating physician.\n* Minimum of six swollen joint counts (SJC) and six tender joint counts (TJC) according to joint assessment.\n\nFor subjects with Sjögren's Disease (SjD)\n\n* Prior diagnosis of Primary SjD as per 2016 ACR\u002FEULAR criteria with confirmatory diagnosis in the 24 weeks preceding screening.\n* Total Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) \\> 6.\n* Salivary Flow Rate \\> 0.1 mL\u002Fmin on stimulation.\n\nFor subjects with Idiopathic Inflammatory Myopathies (IIMs)\n\n* Presence of a positive autoantibody (ANA \\>1:80 or RNP or SSA\u002FSSB or other myositis specific autoantibodies.\n* Refractory IIM as defined by inadequate response\u002Fintolerance to at least 3 months of glucocorticoids and\u002For at least one other immunosuppressive.\n* Muscle biopsy or muscle MRI to confirm IIM diagnosis, where applicable, within 12 months prior to enrollment.\n\nFor Subjects with Systemic Sclerosis (SSc)\n\n* Diagnosis of SSc in accordance with the ACR\u002FEULAR 2013 classification.\n* Modified Rodnan skin score (mRSS) \\> 10.\n* Initial confirmatory diagnosis within 8 years of screening.\n* Refractory SSc as defined by inadequate response\u002Fintolerance to at least 3 months of glucocorticoids and\u002For at least one other immunosuppressive.",{"count":94,"type":21},90,[24],"A Basket Trial of Refractory Rheumatoid Arthritis (RA), Sjögren's Disease (SjD), Idiopathic Inflammatory Myopathies (IIMs) and Systemic Sclerosis (SSc) subjects to evaluate the safety and efficacy of AlloNK, a non-genetically modified allogeneic NK cell, in combination with rituximab.",[98,99,100,101,102,103,104,27,105],"Refractory Rheumatoid Arthritis (RA)","Idiopathic Inflammatory Myopathies (IIMs)","Systemic Sclerosis (SSc)","Rheumatoid Arthritis (RA","IIM","Myositis","Scleroderma","Sjogrens Disease",[107,108,109,110,111,112,113,114,115,116,117,118,119,120,121],"Refractory Rheumatoid Arthritis","AlloNK","Idiopathic Inflammatory Myopathies","Systemic Sclerosis","Sjögren's Disease","Refractory RA","Cell Therapy","Allogeneic NK Cells","Allogeneic Cell Therapy","non-genetically modified","rituximab","cord blood cells","ADCC enhancement","outpatient","community","2026-05-20",{"date":124,"type":39},"2026-05-22",{"date":126,"type":39},"2025-07-09",{"date":128,"type":21},"2029-01",{"name":130,"class":131},"Artiva Biotherapeutics, Inc.","INDUSTRY",{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":144,"conditions":145,"keywords":146,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":47},"100583344","fatigue-in-sjgrens-syndrome-3-therapeutic-strategies-100583344","NCT06875102","Fatigue in Sjögren's Syndrome: 3 Therapeutic Strategies","Fatigue in Sjögren's Syndrome: a Randomized Controlled Trial of Combined Non-pharmacological Therapeutic Strategies","FESSONA","Inclusion Criteria:\n\n* Patient affiliated or entitled to a social security scheme.\n* Age \\> 18 years.\n* Patient informed and having signed the information form and consent to participate in the study.\n* Patient with Sjögren's syndrome according to ACR\u002FEULAR 2016 or AECG 2002 criteria, usually followed up every year or more frequently\n* Fatigue present for ≥ 6 months, without obvious explanation and\u002For specific treatment to conduct (e.g., disease's flare, chronic infection), with a current FACIT-F score \\\u003C 34\n\nExclusion Criteria:\n\n* Pre-existing atrial fibrillation or severe cardiac conduction disorders,\n* Recent stroke or myocardial infarction (\\\u003C6 months),\n* Left ventricular ejection fraction \\\u003C40% or severe heart failure (New York Heart Association functional class III or IV)\n* Recurrent episodes of vasovagal syncope, or history of vagotomy\n* People with dermatological problems in the area where the stimulation electrodes are to be placed\n* Current episode of venous or arterial thrombosis\n* Pregnancy or breastfeeding\n* Patient under protective measures (legal protection, curatorship, guardianship)\n* Inability or refusal to understand and\u002For sign informed consent to participate in the study, or to perform follow-up examinations required under the study",{"count":141,"type":21},174,[143],"NA","Unexplained fatigue is a frequent (60-70%) chronic complaint in Sjögren's syndrome (SjS) with a clear unmet therapeutic need, despite the recommendation of adapted physical activity (APA) programs, which are effective and feasible, but only to some extent. Hence, other therapeutic approaches, such as Acupuncture (ACU) or transcutaneous vagal nerve stimulation (tVNS), have been evaluated during the past years, with varying degrees of success in alleviating fatigue.\n\nFESSONA has been designed as a randomized controlled monocentric trial, aiming at comparing the effects of 3 different programs on fatigue in SjS: APA alone, APA+ACU and APA+tVNS. Relevant controls will be included as well (sham ACU and simulated tVNS).\n\nMultiple fatigue and SjS-related features will be measured before (at inclusion) and after (week 12) the intervention, as well as at week 24 and 48, to evaluate the short- and long-term impact of each program. Tolerance and feasibility will also be evaluated.",[27],[147,148,149,150,151],"Sjögren's Syndrome","fatigue","acupuncture","adapted physical activity (APA)","transcutaneous vagal nerve stimulation (tVNS)","2026-03-26",{"date":154,"type":39},"2026-03-27",{"date":156,"type":39},"2026-03-24",{"date":158,"type":21},"2028-04",{"name":160,"class":46},"Centre Hospitalier Universitaire de Saint Etienne",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":169,"minAge":170,"maxAge":171,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":174,"briefSummary":176,"conditions":177,"keywords":180,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":47},"100604727","phase-4-treatment-of-vaginal-dryness-in-sjgrens-disease-with-co2-laser-versus-topical-promestriene-100604727","NCT07153276","TREATMENT OF VAGINAL DRYNESS IN SJÖGREN'S DISEASE WITH CO2-LASER VERSUS TOPICAL PROMESTRIENE","TREATMENT OF VAGINAL DRYNESS IN SJÖGREN'S DISEASE WITH CO2-LASER VERSUS TOPICAL PROMESTRIENE: A PROSPECTIVE RANDOMIZED STUDY","VaLS","Inclusion Criteria:\n\n* Diagnosis of SjD according to the American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria (2016).\n* Controlled systemic disease activity \\[EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)\\] \\\u003C 5 and without use of glucocorticoids or with a maximum dose of prednisone of 15 mg\u002Fday.\n* Present complaints of vaginal dryness upon study entry.\n* Agreeing to participate in the protocol according to the informed consent form signed before study inclusion.\n\nExclusion Criteria:\n\n* History of breast, uterine or ovarian neoplasia, history of thromboembolic events, heart, kidney or liver failure.\n* Other associated autoimmune rheumatic diseases, such as spondyloarthritis, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, dermatomyositis and mixed connective tissue disease.\n* Conditions that may mimic SjD, such as history of head and neck radiation therapy, acquired immunodeficiency syndrome, hepatitis B and C, sarcoidosis, IgG4-related disease, and graft-versus-host disease.","FEMALE","30 Years","65 Years",{"count":173,"type":21},60,[175],"PHASE4","Sjögren's disease (SjD) is a chronic, immune-mediated, systemic inflammatory disease characterized mainly by involvement of the salivary and lacrimal glands, causing symptoms of sicca syndrome. The disease predominantly affects women (9:1 to 20:1), with a peak incidence between 40 and 60 years of age. Symptoms of dryness include those resulting from vaginitis sicca, such as vulvovaginal irritation, dryness, pruritus, dyspareunia, polyuria, nocturia, dysuria, and urinary urgency\u002Fincontinence, which may begin before and worsen after menopause. These symptoms impact the sexual life and health-related quality of life of SjD patients. However, there are no specific recommendations for the management of vaginal dryness in this disease. Urogenital syndrome (UGS), a condition that affects women from the general population in the menopausal phase, is characterized by similar symptoms and can be treated with systemic or local hormone therapy (e.g., topical promestriene). Current data also demonstrate the efficacy and safety of vaginal fractional CO2 laser treatment for UGS. However, there are no studies on the efficacy of vaginal fractional CO2 laser and topical promestriene in the treatment of vaginal dryness in SjD.",[27,178,179],"Sjogren Disease","Primary Sjogren Syndrome",[32,181,182,183,184],"vaginal dryness","vaginitis sicca","vaginal fractional CO2 laser","promestriene","2026-03-02",{"date":187,"type":39},"2026-03-03",{"date":189,"type":39},"2026-02-27",{"date":191,"type":21},"2030-01-30",{"name":193,"class":46},"University of Sao Paulo General Hospital",{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":201,"enrollmentInfo":202,"targetDuration":4,"studyType":22,"phases":204,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":4},"100616096","early-phase-1-clinical-study-of-bct301-cell-injection-therapy-for-refractory-autoimmune-diseases-100616096","NCT07301164","Clinical Study of BCT301 Cell Injection Therapy for Refractory Autoimmune Diseases","A Study of BCT301 (Anti-CD19 Chemically Induced Pluripotent Stem Cell (CiPSC)-Derived CAR-iT Cells) Therapy for Refractory Autoimmune Diseases","Inclusion Criteria:\n\nGeneral Inclusion Criteria\n\n1. Voluntarily sign the informed consent form.\n2. Male or female, aged 18-80 years (inclusive), with a body weight ≥40 kg.\n3. Female participants of childbearing potential and male participants with female partners of childbearing potential must use medically approved contraceptive methods or practice abstinence during the treatment period and for at least 6 months after the end of the treatment. Female participants of childbearing potential must have a negative serum human chorionic gonadotropin (HCG) test within 7 days prior to enrollment and must not be breastfeeding.\n4. Participants currently receiving one or more of the following treatments at stable doses: glucocorticoids, antimalarials, immunosuppressants:\n\n   1. If the participant is receiving glucocorticoid therapy, the following conditions must be met: the maximum dose at screening and during the screening period is 30 mg\u002Fday of prednisone (or equivalent). The dose must have been stable for ≥7 days prior to screening, and adjustments during the screening period must not exceed 5 mg\u002Fday of prednisone (or equivalent);\n   2. If the participant is receiving antimalarials and\u002For conventional immunosuppressants: the treatment must have been initiated ≥12 weeks prior to screening. The dose must have been stable for ≥8 weeks prior to screening and remain stable during the screening period;\n   3. If biological agents (belimumab, telitacicept, rituximab, etc.) were used prior to the screening period, a washout period of at least 5 half-lives must be completed before screening.\n5. Peripheral blood B cells must show positive CD19 expression as detected by flow cytometry.\n\nDisease-Specific Inclusion Criteria\n\n1\\. Systemic Lupus Erythematosus (SLE)\n\n1. Meet the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) classification criteria for SLE.\n2. Have moderate to severe disease activity at screening, with a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2000) score \\>6.\n3. Have inadequate response to conventional therapy or experience disease relapse after remission. Conventional therapy includes glucocorticoids (at full or pulse doses), two or more immunosuppressants, or biologic agents for at least 6 months, including cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, leflunomide, methotrexate, belimumab, telitacicept, and rituximab.\n4. Have positive serological autoantibody tests: positive antinuclear antibodies (ANAs) and\u002For anti-ds-DNA antibodies and\u002For anti-Sm antibodies.\n\n2\\. Systemic Sclerosis (SSc)\n\n1. Meet the 2013 EULAR\u002FACR classification criteria for SSc.\n2. Fulfill either (a) or (b) below:\n\n   1. Inadequate response to conventional therapy or disease relapse after remission. Conventional therapy includes glucocorticoids (at full or pulse doses), two or more immunosuppressants, or biologic agents for at least 6 months, including cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, leflunomide, methotrexate, belimumab, telitacicept, and rituximab.\n   2. Disease progression: skin progression with a modified Rodnan Skin Score (mRSS) ≥10; and\u002For interstitial lung disease evidenced by ground-glass opacities on high-resolution computed tomography (HRCT); a decline in forced vital capacity (FVC) ≥10%, or a decline in FVC ≥5% accompanied by a decline in diffusing capacity for carbon monoxide (DLCO) ≥15%.\n3. Have positive SSc-related autoantibodies. 3. Antiphospholipid Syndrome (APS)\n\n1\\) Meet the 2006 Sydney criteria for primary antiphospholipid syndrome. 2) Have medium to high titers of antiphospholipid antibodies (lupus anticoagulant \\[LA\\], anti-β2-glycoprotein 1 \\[β2GP1\\] IgG\u002FIgM, or anti-cardiolipin \\[aCL\\] IgG\u002FIgM); 3) Fulfill either (a) or (b) below:\n\n1. Receiving standard treatment with warfarin or alternative vitamin K antagonists (maintaining target international normalized ratio \\[INR\\]), or standard therapeutic doses of low molecular weight heparin (LMWH), and\u002For glucocorticoids and immunosuppressants\u002Fbiologics (e.g., cyclophosphamide, cyclosporine, tacrolimus, rituximab, etc.).\n2. Meet all four criteria for catastrophic APS:\n\ni) Involvement of three or more organs, systems, and\u002For tissues; ii) Development of manifestations within one week; iii) Histopathological confirmation of small vessel occlusion in at least one organ or tissue; iv) Positive antiphospholipid antibodies (aPL).\n\n4\\. Inflammatory Myopathy (IM)\n\n1. Meet the 2017 EULAR\u002FACR classification criteria for inflammatory myopathy (including dermatomyositis, polymyositis, anti-synthetase syndrome, and immune-mediated necrotizing myopathy).\n2. Have positive myositis-specific autoantibodies.\n3. For participants with muscle involvement: a Manual Muscle Test-8 (MMT-8) score \\\u003C142, and at least two of the following five core abnormalities: Physician Global Assessment ≥2, Patient Global Assessment ≥2, or extramuscular disease activity score ≥2; Health Assessment Questionnaire (HAQ) total score ≥0.25; muscle enzyme levels ≥1.5 times the upper limit of normal; or MMT-8 ≥142 but with active interstitial lung disease (ground-glass opacities on HRCT).\n\n5\\. Sjögren's Syndrome (SS)\n\n1. Meet the 2016 ACR\u002FEULAR classification criteria for Sjögren's syndrome.\n2. Have a EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ≥5.\n3. Have positive anti-SSA\u002FRo antibodies.\n4. Have inadequate response to conventional therapy or disease relapse after remission. Conventional therapy includes glucocorticoids (at full or pulse doses), two or more immunosuppressants, or biologic agents for at least 6 months, including cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, leflunomide, methotrexate, belimumab, telitacicept, and rituximab.\n\n6\\. Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis (AAV)\n\n1. Meet the 2022 ACR\u002FEULAR classification criteria for ANCA-associated vasculitis (AAV), including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis.\n2. Have a history of or currently positive ANCA.\n3. Have a Birmingham Vasculitis Activity Score (BVAS) ≥15 (total score 63).\n4. Have inadequate response to conventional therapy or disease relapse after remission. Conventional therapy includes glucocorticoids (at full or pulse doses), two or more immunosuppressants, or biologic agents for at least 6 months, including cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, leflunomide, methotrexate, belimumab, telitacicept, and rituximab.\n\nExclusion Criteria:\n\nStudy participants who meet any of the following criteria will be excluded from the study:\n\n1. Any medical condition that, in the opinion of the investigator, would contraindicate participation in the study, such as a life-threatening illness.\n2. Decreased organ function reserve not attributable to the primary disease:\n\n   a) Neutrophil count \\\u003C1×10⁹\u002FL; lymphocyte count \\\u003C0.3×10⁹\u002FL; hemoglobin \\\u003C70 g\u002FL; platelet count \\\u003C50×10⁹\u002FL; b) Alanine aminotransferase (ALT) \\>3 × upper limit of normal (ULN); aspartate aminotransferase (AST) \\>3 × ULN; total bilirubin \\>2 × ULN; c) Creatinine clearance \\\u003C40 mL\u002Fmin; estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m²; or serum creatinine \\>2.5 mg\u002FdL; d) Left ventricular ejection fraction (LVEF) \\\u003C45% as measured by echocardiography; e) Oxygen saturation \\\u003C92% on room air.\n3. History of alcohol or substance abuse within the past 24 weeks.\n4. History of malignancy other than B-cell lymphoma.\n5. Presence of infections including human immunodeficiency virus (HIV), hypogammaglobulinemia, T-cell deficiency, syphilis, chronic hepatitis B or C, or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).\n6. Known active tuberculosis (TB) infection or active bacterial infection.\n7. History of myocardial infarction, coronary angioplasty or stenting, unstable angina, clinically significant arrhythmia, or other clinically significant cardiac disease within 6 months prior to screening.\n8. Symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to screening, except in cases of antiphospholipid syndrome (APS).\n9. History of severe allergic reaction to any component of cellular therapy or other immunotherapeutic agents.\n10. Prior organ transplant requiring ongoing immunosuppressive therapy.\n11. Concurrent participation in another clinical trial that may interfere with disease assessment or study treatment.\n12. Prior treatment with CD19- and\u002For BCMA-targeted therapy or any CAR-T cell product; except in cases where prior therapy is deemed to have clearly failed (e.g., no response, short duration of response, or disease progression) as assessed by the investigator, the current disease state warrants the study treatment, and there is no clear evidence that toxicity from prior therapy would compromise the safety of the current study.\n13. Severe psychiatric disorder or significant cognitive impairment.\n14. Pregnancy, lactation, or planned pregnancy.\n15. Any other condition that, in the judgment of the investigator, would make the participant unsuitable for enrollment in this clinical trial.","80 Years",{"count":203,"type":21},10,[205],"EARLY_PHASE1","This study primarily involves the use of BCT301, an anti-CD19 Chemically induced pluripotent stem cell (CiPSC)-derived CAR-iT cells, for the treatment of patients with refractory autoimmune diseases, aiming to evaluate its safety, tolerability, and dose-limiting toxicities(DLT), and to determine the recommended therapeutic dose for further investigation. Additionally, the study assesses the efficacy of BCT301 cell injection in refractory autoimmune diseases, as well as the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics in study participants.",[208,100,209,210,211,27],"System Lupus Erythematosus","Inflammatory Myositis","Antiphospholipid Syndrome","ANCA Associated Vasculitis","2025-12-09",{"date":214,"type":39},"2025-12-24",{"date":216,"type":21},"2025-12-11",{"date":218,"type":21},"2028-12-31",{"name":220,"class":46},"Peking University Third Hospital",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":229,"targetDuration":230,"studyType":231,"phases":4,"briefSummary":232,"conditions":233,"keywords":238,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":251,"locationsCount":47},"100612090","interferon-signature-in-anti-ctla-4-and-anti-pd-1pd-l1-treated-cancer-patients-compared-with-systemic-autoimmune-disease-patients-100612090","NCT07249060","Interferon Signature in Anti-CTLA-4 and Anti-PD-1\u002FPD-L1-Treated Cancer Patients Compared With Systemic Autoimmune Disease Patients","Interferon Signature in Cancer Patients Treated With Anti-CTLA-4 and Anti-PD-1\u002FPD-L1 Therapies: A Multicenter, Prospective, Observational Cohort Study Comparing Cancer Patients and Non-Cancer Patients With Systemic Autoimmune Diseases","INTER-AUTENTIC","ICI cohort:\n\nInclusion Criteria:\n\n* Initiation of treatment with a single ICI or dual ICI therapy in accordance with current clinical guidelines;\n* Patients who are treatment-naïve to ICIs; and\n* Age ≥18 years.\n\nExclusion Criteria:\n\n* Estimated mortality of less than 3 months from the start of treatment;\n* Current combination therapy with chemotherapy, tyrosine kinase inhibitors, or other tumor-specific treatments;\n* Contraindication to treatment with ICIs (documented hypersensitivity, severe active autoimmune disease, Eastern Cooperative Oncology Group \\[ECOG\\] ≥3);\n* Ongoing immunosuppressive therapy, including prednisone at doses \\>10 mg\u002Fday or equivalent.\n\nSAD cohort:\n\nInclusion Criteria:\n\n* Meeting classification criteria for Systemic Lupus Erythematosus (SLE) (ACR\u002FEULAR 2019), Primary Sjögren's Syndrome (pSS) (ACR\u002FEULAR 2016), Systemic Sclerosis (SSc) (ACR\u002FEULAR 2013), and\u002For Idiopathic Inflammatory Myopathy (IIM) (ACR\u002FEULAR 2017).\n* Age ≥18 years old.\n\nExclusion Criteria:\n\n* Estimated mortality less than 3 months from the start of follow-up.\n* Active immunosuppressive treatment, including prednisone at doses \\>10 mg\u002Fday or equivalent.\n* Recent diagnosis (\\\u003C1 year) of cancer, with the exception of non-melanoma skin cancer, or currently receiving active oncology-specific treatment.",{"count":56,"type":21},"48 Weeks","OBSERVATIONAL","This study aims to identify a way to predict the side effects that some people with cancer experience when receiving immunotherapy. These side effects, known as immune-related adverse events (irAEs), occur when the immune system mistakenly attacks healthy tissues, like certain autoimmune diseases. At present, clinicians lack reliable tests to determine who is most likely to develop these reactions. The goal of this study is to determine whether substances in the blood called interferons (IFNs) could serve as early warning markers.\n\nThe study will include 300 people with cancer who are about to begin immunotherapy. To provide a meaningful comparison, the investigators will also enroll 40 individuals with autoimmune diseases such as lupus. Understanding how IFN levels differ between these groups may help clarify whether IFN patterns in cancer patients resemble those seen in autoimmune disease.\n\nParticipants in both groups will be asked to provide small blood samples at predefined time points during their clinical care or treatment. Researchers will measure the levels of different IFN types in all samples to compare IFN levels between cancer patients and individuals with autoimmune diseases, and within the cancer group between patients who develop irAEs and those who do not. The long-term aim of the study is to develop a simple test that can help clinicians identify patients at higher risk of irAEs.\n\nImmune-related adverse events (irAEs) are a frequent complication in cancer patients treated with immune checkpoint inhibitors (ICIs), and they often resemble or exacerbate preexisting autoimmune diseases. Despite extensive research in the field, no validated predictive biomarkers of irAEs currently exist. Emerging evidence suggests that the IFN signature -long implicated in the pathogenesis of several systemic autoimmune diseases (SADs)- may also be upregulated in patients who develop ICI-induced irAEs, likely with substantial overlap among different IFN subtypes. Given these clinical and molecular similarities with SADs, it is plausible that IFN levels in peripheral blood carry predictive value for irAE risk, although the dominant IFN types in ICI-related toxicity remain unknown.\n\nThe INTER-AUTENTIC project aims to determine whether baseline IFN levels and their dynamic changes, measured in peripheral blood using a dedicated panel, can predict the onset of irAEs in cancer patients receiving ICIs. Supported by the Medical Oncology departments of six university hospitals in Northern Spain, this multicenter, observational, prospective cohort study has been underway since 2021. Biobank samples have been collected from ICI-treated patients before treatment initiation, at protocol-defined time points, and at the moment of irAE diagnosis (ICI cohort). The study seeks to identify the IFN subtypes with the most pronounced differential expression between patients with and without irAEs, and to evaluate whether IFN levels enhance the predictive performance of a model incorporating other clinical variables potentially associated with immune-mediated toxicity. A sample size of 300 cancer patients has been estimated for this analysis.\n\nIn addition, a second prospective cohort of 40 non-cancer patients with systemic lupus erythematosus, primary Sjögren's syndrome, systemic sclerosis, and\u002For idiopathic inflammatory myopathy (SAD cohort) will be included. Since IFNs play a well-established pathogenic role in these conditions, this cohort will allow characterization of the IFN signature at key follow-up points (baseline, remission, and disease flare) and comparison with the IFN profiles of ICI-treated patients, regardless of whether they develop irAEs.",[234,235,27,100,236,237],"Immune-Related Adverse Events","Lupus Erythematosus, Systemic","Inflammatory Myopathies","Solid Tumors",[239,240,241,242,243,244],"Immune Checkpoint Inhibitors","Adverse events","Biomarkers","Predictive","Prospective Studies","Immune System","2025-11-25",{"date":247,"type":39},"2025-12-03",{"date":249,"type":39},"2024-01-08",{"date":41,"type":21},{"name":252,"class":46},"Hospital Universitario Araba",{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":201,"enrollmentInfo":260,"targetDuration":4,"studyType":22,"phases":262,"briefSummary":263,"conditions":264,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":47},"100579726","phase-1-safety-and-efficacy-of-universal-cd19-targeting-car-t-cells-in-refractory-autoimmune-diseases-100579726","NCT06828042","Safety and Efficacy of Universal CD19-targeting CAR-γδT Cells in Refractory Autoimmune Diseases","A Single-center Clinical Study Evaluating the Safety and Efficacy of Universal CD19-targeting CAR-γδT Cells（QH103） in Refractory Autoimmune Diseases","Inclusion Criteria:\n\nCommon Inclusion Criteria:\n\n1. Age between 18-80 years (inclusive), male or female.\n2. Positive expression of CD19 on peripheral blood B cells by flow cytometry.\n3. Diagnosed with refractory autoimmune disease, defined as: Ineffectiveness of conventional treatment for more than 6 months, or Disease activity recurrence after remission. Definition of conventional treatment: Use of glucocorticoids and any of the following immunosuppressants or biologics: cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, rituximab, belimumab, telitacicept, etc.\n4. Currently receiving one or more standard therapies at a stable dose, including glucocorticoids, antimalarials, immunosuppressants, or biologics. If the subject is receiving glucocorticoids, the following conditions must be met: During screening and the screening period, the maximum dose of glucocorticoids is 30 mg\u002Fday prednisone (or an equivalent dose). The glucocorticoid dose must remain stable for ≥7 days before screening, and during the screening period, the dose adjustment must not exceed \\>5 mg\u002Fday prednisone (or an equivalent dose). If the subject is receiving antimalarials and\u002For conventional immunosuppressants: The treatment must have started ≥12 weeks before screening. The medication dose must remain stable for ≥8 weeks before screening and throughout the screening period. Before cell infusion, other immunosuppressants (excluding hydroxychloroquine), including belimumab, telitacicept, CD20 monoclonal antibodies, or other biologic immunosuppressants, must be discontinued for at least 5 half-lives.\n5. Female participants of childbearing potential and male participants with female partners of childbearing potential must use medically approved contraceptive methods or practice abstinence during the study treatment period and for at least 6 months after the study. Female participants of childbearing potential must have a negative serum HCG test within 7 days before enrollment and must not be breastfeeding.\n6. Willing to participate in the trial and sign the informed consent form.\n\nDisease-Specific Inclusion Criteria:\n\n1. Systemic Lupus Erythematosus (SLE):\n\n   * Meets the 2019 EULAR\u002FACR classification criteria for SLE.\n   * ANA titer ≥1:80, or positive for anti-dsDNA and\u002For anti-Sm antibodies.\n   * Disease activity score (SLEDAI-2000) ≥8.\n2. Sjögren's Syndrome:\n\n   * Meets the 2002 AECG criteria or the 2016 ACR\u002FEULAR classification criteria for primary Sjögren's syndrome.\n   * Disease activity score (ESSDAI) ≥5.\n   * Positive for anti-SSA\u002FRo antibodies.\n3. Systemic Sclerosis (SSc):\n\n   * Meets the 2013 EULAR\u002FACR classification criteria for systemic sclerosis.\n   * Classified by Leroy and Medsger as limited or diffuse cutaneous subsets.\n   * At screening, mRSS \\>10; and\u002For active interstitial lung disease (ILD), defined as: High-resolution computed tomography (HRCT) showing ground-glass opacities. Pulmonary function tests (FVC or DLCO) \\\u003C70% of predicted values.\n4. Idiopathic Inflammatory Myopathies (IIM):\n\n   * Meets the 2017 EULAR\u002FACR classification criteria for inflammatory myopathies (including dermatomyositis, polymyositis, antisynthetase syndrome, and necrotizing myopathy).\n   * For patients with muscle involvement: a. MMT-8 score \\\u003C142 and at least two abnormal findings among the following core measures: PhGA or PtGA scores ≥2. Extramuscular disease activity score ≥2. HAQ total score ≥0.25. Muscle enzyme levels ≥1.5 times the upper normal limit. b. Alternatively, MMT-8 ≥142 but with active ILD (HRCT showing ground-glass opacities).\n   * Positive for myositis-specific antibodies.\n5. ANCA-Associated Vasculitis (AAV):\n\n   * Meets the 2022 ACR\u002FEULAR diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, or eosinophilic granulomatosis with polyangiitis.\n   * Positive for ANCA antibodies (current or historical).\n   * Birmingham Vasculitis Activity Score (BVAS) ≥15 (out of 63), indicating active vasculitis.\n6. Refractory Antiphospholipid Syndrome (APS):\n\n   * Meets the 2023 ACR\u002FEULAR diagnostic criteria for antiphospholipid syndrome.\n   * Positive for medium-to-high titers of antiphospholipid antibodies (LA, anti-β2-GP1, or ACL IgG\u002FIgM), with at least two positive results within 3 months.\n   * Definition of refractory APS: Disease remains active or relapses after remission, despite 6 months of conventional therapy, including: Anticoagulants (warfarin or standard treatment with vitamin K antagonists maintaining target INR) or low-molecular-weight heparin at standard doses. Glucocorticoids and\u002For immunosuppressants.\n   * Catastrophic APS (CAPS): Must meet all four criteria: a. Involvement of three or more organs, systems, and\u002For tissues. b. Symptoms occurring within one week. c. Histological evidence of small vessel occlusion in at least one organ or tissue. d. Positive for antiphospholipid antibodies (aPL).\n\nNote: Meeting either criterion 3 or 4 is sufficient. Patients with thrombocytopenia may not require anticoagulant therapy.\n\nExclusion Criteria:\n\n1. History of severe drug allergies or allergic constitution.\n2. Presence or suspicion of uncontrolled or treatment-requiring fungal, bacterial, viral, or other infections.\n3. Central nervous system (CNS) diseases caused by autoimmune or non-autoimmune conditions, including epilepsy, psychiatric disorders, organic brain syndrome, cerebrovascular accidents, encephalitis, or CNS vasculitis.\n4. Dysfunction of major organs not meeting the following criteria (exceptions allowed if abnormalities are caused by autoimmune disease): a. Bone marrow function: White blood cell count ≥3×10⁹\u002FL. Neutrophil count ≥1×10⁹\u002FL (without GSF treatment within 2 weeks prior to testing). Hemoglobin ≥60 g\u002FL. Platelet count ≥50×10⁹\u002FL. b. Liver function: ALT ≤3×ULN (exceptions for ALT elevation caused by inflammatory myopathy). AST ≤3×ULN (exceptions for AST elevation caused by inflammatory myopathy). IBIL ≤1.5×ULN (exceptions for Gilbert's syndrome). Total bilirubin ≤3.0×ULN. c. Renal function: Creatinine clearance (CrCl) ≥30 mL\u002Fmin (calculated using the Cockcroft\u002FGault formula, exceptions for acute CrCl decline caused by the disease itself). d. Coagulation function: International normalized ratio (INR) ≤1.5×ULN. Prothrombin time (PT) ≤1.5×ULN. e. Cardiac function: Stable hemodynamics.\n5. Subjects with congenital immunoglobulin deficiencies.\n6. History of malignancy within the past five years.\n7. Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA levels exceeding the detection limit; positive hepatitis C virus (HCV) antibodies with detectable HCV RNA in peripheral blood; positive HIV antibodies; or positive syphilis test results.\n8. Subjects with psychiatric disorders or severe cognitive impairment.\n9. Participation in other clinical trials within 3 months prior to enrollment.\n10. Previous treatment with CAR-T therapy.\n11. History of severe adverse reactions to cyclophosphamide or fludarabine.\n12. Any other reason that the investigator determine that subjects cannot be included in this study.",{"count":261,"type":21},9,[58,24],"Autoimmune diseases refer to a common category of diseases caused by the immune system reacting to self-antigens, leading to tissue damage. Autoimmune diseases encompass a wide variety of conditions, such as systemic lupus erythematosus（SLE）, Sjögren's syndrome (SS), systemic sclerosis (SSc), inflammatory myopathies (IM), ANCA-associated vasculitis (AAV), and antiphospholipid syndrome (APS). They affect the quality of life, while in severe cases, they can be life-threatening. Additionally, they impose a heavy economic burden on society. Current treatments for autoimmune diseases include glucocorticoid, immunosuppressants, and biologics. B cell-driven humoral immune abnormalities are a central pathogenic mechanism in many autoimmune diseases. When autoreactive B cells are excessively activated, they produce large amounts of autoantibodies and immune complexes. These antibodies and immune complexes can cause damage to various tissues and organs, leading to the development of multiple autoimmune diseases. Therefore, targeting B cells to treat autoimmune diseases is an attractive therapeutic strategy.\n\nChimeric Antigen Receptor (CAR)-T cells targeting the B cell surface molecule CD19 have achieved significant clinical progress in acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma, with several CD19 CAR-T therapies approved for marketing worldwide. Increasingly, clinical studies are exploring the use of CD19 CAR-T cells for the treatment of autoimmune diseases, and their therapeutic efficacy has been demonstrated.\n\nIn this study, the investigators used γδ T cells as carrier cells to investigate the safety and efficacy of universal CAR-γδ T cells in the treatment of autoimmune diseases.",[265,100,27,266,236,210],"Systemic Lupus Erthematosus","ANCA Associated Vasculitis (AAV)","2025-08-14",{"date":269,"type":39},"2025-08-20",{"date":271,"type":39},"2025-07-01",{"date":273,"type":21},"2027-12-31",{"name":220,"class":46},{"id":276,"slug":277,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":171,"enrollmentInfo":282,"targetDuration":4,"studyType":22,"phases":284,"briefSummary":285,"conditions":286,"keywords":292,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":302,"locationsCount":47},"100577108","phase-2-bcma-cd19-car-t-therapy-for-refractory-autoimmune-diseases-100577108","NCT06794008","BCMA-CD19 CAR-T Therapy for Refractory Autoimmune Diseases","An Open, Single-Arm, Single-Center Clinical Study Assessing the Safety and Efficacy of BCMA-CD19 Targeted Chimeric Antigen Receptor T-Cell Therapy in Multiple Refractory Autoimmune Diseases","Inclusion Criteria:\n\n1. Age, 18-65 years old (inclusive), weight \\>=45kg, male and female;\n2. The diagnosis of each disease meets the following criteria:\n\nSystemic lupus erythematosus: 1997 ACR classification criteria or 2012 SLICC classification criteria Sjögren's syndrome: 2002 International Classification of Sjögren's Syndrome Inflammatory myopathies: 1977 Bohan Recommendation Systemic sclerosis: 1980 ACR classification criteria or 2013 ACR-EULAR classification criteria Behcet's disease: 1989 International Classification Criteria for Behcet's disease ANCA-associated vasculitis: 1990 ACR classification criteria IgG4-related disease: 2011 IgG4-RD composite diagnostic criteria Antiphospholipid syndrome: 2006 revision of the Sapporo APS classification criteria Acquired thrombotic thrombocytopenic purpura: consistent with a clinical diagnosis of TTP, including microscopic evidence of thrombocytopenia and red blood cell fragmentation (e.g., red blood cell fragmentation) 3. Multiple treatment regimens are ineffective or ineffective (including but not limited to high-dose glucocorticoids, adequate immunosuppressants and biologics) 4. Use of glucocorticoids (\\\u003C=1mg\u002Fkg\u002Fd prednisone or equivalent doses of other hormones), DMARDs (such as methotrexate, hydroxychloroquine, azathioprine, mycophenolate mofetil, leflunomide, cyclosporine, etc.) must be on stable treatment for 4 weeks before receiving the first study drug, and no increase in hormone dose and other immunosuppressants throughout the study.\n\n5\\. Subjects voluntarily participate in this study and voluntarily sign the informed consent form; 6. Subjects who have the possibility of having children or whose partners have the possibility of having children must agree to use effective contraception throughout the study period (but cannot use oral estrogen, use estrogen vaginal ring, etc.) 7. Additional enrollment criteria for different diseases (related to the degree of disease activity):\n\n1. Patients with Behcet's disease must be active patients who meet the following conditions, and the active phase is defined as the emergence of new symptoms or the deterioration of existing symptoms, and one of the following conditions must be met:\n\n   A. Organ involvement: involvement of any major organ (e.g., ocular lesions, vascular lesions, central nervous system, gastrointestinal system); B. 100% increase in the number of oral or genital ulcers \\>=compared to the onset of oral\u002Fgenital ulcers compared to the first day; or an increase in the number of oral or genital ulcers by 3; C. Canker disease is at least 12 months; D. History of several oral ulcers per month E. Arthritis: \\>=50% increase in the number of swollen joints, or 3 more swollen joints; F. Skin lesions (non-oral\u002Fgenital ulcers): \\>= physician overall lesion score increased by \\>=50% or by two points in the total score.\n2. Patients with active inflammatory myopathy need to meet the following additional conditions:\n\n   Active myositis as defined by the Baseline Freehand Muscle Strength Test (MMT-8) of no more than 125\u002F150 and at least 2 additional CSMs that meet the criteria specified below:\n\n   a) Visual Analogue Scale\\[VAS\\] of patient global activity ≥2 cm, b) physician's global disease activity ≥2 cm, c) Health Assessment Questionnaire (HAQ) Disability Index ≥ 0.25 d) Elevation of at least one muscle enzyme \\[including creatine kinase (CK), aldolase, lactate dehydrogenase (LDH), alanine aminotransferase (ALT), and aspartate aminotransferase (AST)\\] with a minimum level of 1.3 x upper limit of normal e) Global Extramuscular Disease Activity Score, with a minimum of 1.0 cm on a 10 cm VAS scale \\[This measure is a physician's comprehensive assessment based on the assessment of physique, skin, bone, gastrointestinal, lung, and cardiac activity scale activity scores using the Myositis Disease Activity Assessment Tool (MDAAT).\n\n   f) To ensure that we are able to recruit patients with active DM with severe rash who may not meet the MMT-8 criteria above, we recommend the use of additional inclusion criteria so that the International Myositis Assessment and Clinical Study (IMACS) Improved Definition (DOI) can be achieved: 1) MDAAT \\> on the 10 cm VAS scale 3 cm skin VAS score, and 2) at least 3 of the above 5 criteria.\n3. ANCA-associated vasculitis:\n\n   A. Comply with GPA\u002FMPA\u002FEGPA classification standards; B. Patients with severe vasculitis activity (meeting at least one of the following conditions);\n\n   a) Renal involvement is characterized by one of the following: i. Evidence of glomerulonephritis in any of the following situations: Renal biopsy shows focal necrotizing glomerulonephritis. Active urinary sediment characterized by glomerular hematuria and proteinuria ii. Patients with prior normal or no prior renal disease document, estimated glomerular filtration rate (eGFR) \\\u003C50 ml\u002Fmin\u002F1.73 m2, and prior chronic kidney disease (eGFR \\\u003C60 ml\u002Fmin\u002F1.73 m2) showed a reduction in eGFR of at least 25% compared with the previous one.\n\n   b) Pulmonary hemorrhage due to active vasculitis satisfies all three of the following: i. Chest X-ray or CT scan showing diffuse pulmonary infiltrates ii. Pulmonary infiltrates that cannot be explained by other causes (e.g., volume overload or pulmonary infection) iii. At least one of the following: Evidence of alveolar hemorrhage on bronchoscopy or bloody bronchoalveolar lavage Hemoptysis was observed Unexplained anemia (\\\u003C10 g\u002FdL) or decreased hemoglobin (\\>1 g\u002FdL) and less than 10g\u002FdL Increased carbon dioxide dispersion\n4. Additional Enrollment Criteria for Systemic Sclerosis:\n\n   Subjects are at high risk of fatal outcomes based on the following prognostic factors: Subjects must have the following \"a\" , and at least one of \"b\" or \"c\".\n\n   a) Diffuse cutaneous scleroderma with an mRSS score of \\>=16, validated by the same physician at 2 different times \\>= 1 day apart and separated by \\\u003C 28 days.\n\n   b) Presence of SSc-related lung disease with FVC \\\u003C 70% or 70% predicted DLCO \\\u003C after hemoglobin correction and evidence of alveolitis obtained by high-resolution chest CT scan or PAL.\n\n   c) History of SSc-related nephropathy, no disease activity before enrollment screening. A history of hypertensive renal crisis with scleroderma is included in this criterion and is defined as follows: i. History of new-onset hypertension based on any of the following (must be repeated and confirmed at least 2 hours apart within 3 days of the first event) with change from baseline SBP\\>=140 mmHg DBP\\>=90 mmHg SBP rose by \\>=30 mmHg compared to baseline DBP increased by \\>=20 mmHg compared to baseline AND ii. One of the following 5 characteristics Serum creatinine increased \\>= \\>50% from baseline proteinuria: \\>=2+; Creatinine ratio \\> upper limit of normal Thrombocytopenia: \\\u003C100, 000 plts\u002Fmm3 Hemolysis: increased by blood smear or reticulocyte count\n5. Additional enrollment criteria for systemic lupus erythematosus A. The SLEDAI score of the patient before enrollment \\>= 7 points B. Failure to receive the following treatments: oral prednisone \\>=20 mg\u002Fd; Cyclophosphamide 0.4 to 0.6 g\u002Fm2 once every two weeks for 6 months, or other immunosuppressants such as mycophenolate mofetil 2 g\u002Fday for 3 months without remission.\n6. Additional enrollment criteria for antiphospholipid syndrome A. Cardiolipin antibody, lupus anticoagulant factor, and anti-β2-glycoprotein 1 antibody were all positive before enrollment.\n\n   B. History of thromboembolism or morbid pregnancy confirmed by clear objective evidence.\n7. Sjögren's disease additional enrollment criteria A. Positive anti-Ro\u002FSSA antibody screen. B. ESSDAI\\>= 6 POINTS\n8. Additional enrollment criteria for IgG4-related diseases (confirmed: A+ B+C) A. Clinical examination showing the presence of characteristic diffuse\u002Flocal swelling or masses in a single or multiple organs.\n\nB. Blood tests show elevated serum IgG4 concentration (135 mg\u002Fdl). C. Histopathological examination shows significant lymphocytic and plasmacytic infiltration and fibrosis or IgG4+ plasmacyte infiltration (IgG4+\u002FIgG+ cell ratio \\>40% and \\>10 IgG4+ plasma cells\u002FHPF).\n\nExclusion Criteria:\n\n1. Use of rituximab or other monoclonal antibodies within 1.6 months.\n2. Received high-dose glucocorticoids (\\>1 mg\u002Fkg\u002Fd) within 1 month.\n3. Serious complications: including heart failure (\\>= NYHA Class III), renal insufficiency (creatinine clearance \\\u003C=30 ml\u002Fmin), hepatic insufficiency (serum ALT or AST greater than three times the upper limit of normal, or total bilirubin greater than the upper limit of normal)\n4. Other severe, progressive, or uncontrollable hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral diseases (including demyelinating diseases such as multiple sclerosis).\n5. Known allergies, hyperreactivity, or intolerance to IL-2 or its excipients.\n6. Have a serious infection (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, Epstein-Barr virus, tuberculosis infection), or hospitalization for infection, or use of intravenous antibiotics for treatment of infection 2 months prior to the first dose of treatment.\n7. Chest imaging showing malignancy or current activity within 3 months prior to the first use of study drug Abnormalities in sexually transmitted infections (including tuberculosis).\n8. Infection with HIV (HIV antibody-positive serology) or hepatitis C (Hep C antibody-positive serology).\n\nIf seropositive, it is advisable to consult a physician with expertise in the treatment of HIV or hepatitis C virus infection.\n\n10\\. Any known malignancy or history of malignancy within the past 5 years (with the exception of non-melanoma skin cancer, non-melanoma skin cancer with no signs of recurrence or surgically cured cervical tumor within 3 months prior to the use of the first investigational agent).\n\n11\\. Have an uncontrolled mental or emotional disorder, including a history of drug and alcohol abuse within the past 3 years, which may preclude the successful completion of the study.\n\n12\\. Received or anticipated receipt of any live viral or bacterial vaccine injection within 3 months prior to the first injection of study dose, during the study, or within 4 months after the last injection of study dose. Bacillus Calmette-Guérin vaccination within 12 months of screening.\n\n13\\. Pregnant, lactating women (WCBP) who are unwilling to use medically approved contraception during treatment and for 12 months after the end of treatment.\n\n14\\. Males whose partner is of childbearing potential but who are unwilling to use appropriate medically approved contraception during treatment and for 12 months after the end of treatment.\n\n15\\. Patients with inflammatory myopathies should additionally exclude: 3) Adolescent DM or PM, myositis overlaps with another connective tissue disease, cancer-associated myositis, inclusion body myositis, or any other non-immune-mediated myopathy.\n\n4\\) Severe muscle impairment is defined as a baseline global muscle impairment score of MDI (Myositis Injury Index) \\>=5cm on 10 cm VAS.\n\n16\\. ANCA-associated vasculitis requires additional exceptions: positive anti-GBM antibodies.",{"count":283,"type":21},50,[24],"The objective of this study is to evaluate the efficacy and safety of BCMA\u002FCD19 chimeric antigen receptor (CAR)-modified T cells in the treatment of autoimmune diseases.",[71,287,100,288,289,210,290,291,27],"Inflammatory Myopathy","ANCA-associated Vasculitis","IgG4-Related Diseases","Acquired Thrombotic Thrombocytopenic Purpura","Behcet Disease",[293,294,295],"CAR-T","CD19","BCMA","2025-04-01",{"date":298,"type":39},"2025-04-02",{"date":300,"type":39},"2024-12-26",{"date":273,"type":21},{"name":303,"class":46},"Peking University People's Hospital",{"id":305,"slug":306,"hasResults":11,"nctId":307,"briefTitle":308,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":201,"enrollmentInfo":310,"targetDuration":4,"studyType":22,"phases":311,"briefSummary":312,"conditions":313,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":320,"locationsCount":4},"100579235","phase-1-safety-and-efficacy-of-universal-car-t-cells-uwd-cd19-combined-with-immunosuppressants-in-the-treatment-of-refractory-autoimmune-diseases-100579235","NCT06821659","Safety and Efficacy of Universal CAR-T Cells (UWD-CD19) Combined with Immunosuppressants in the Treatment of Refractory Autoimmune Diseases","Inclusion Criteria:\n\n1. Age between 18-80 years (inclusive), male or female.\n2. \\>40kg.\n3. Diagnosed with refractory autoimmune disease, defined as: Ineffectiveness of conventional treatment for more than 6 months, or Disease activity recurrence after remission. Definition of conventional treatment: Use of glucocorticoids and any of the following immunosuppressants or biologics: cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, rituximab, belimumab, telitacicept, etc.\n4. Currently receiving one or more standard therapies at a stable dose, including glucocorticoids, antimalarials, immunosuppressants, or biologics. If the subject is receiving glucocorticoids, the following conditions must be met: During screening and the screening period, the maximum dose of glucocorticoids is 30 mg\u002Fday prednisone (or an equivalent dose). The glucocorticoid dose must remain stable for ≥7 days before screening, and during the screening period, the dose adjustment must not exceed \\>5 mg\u002Fday prednisone (or an equivalent dose). If the subject is receiving antimalarials and\u002For conventional immunosuppressants: The treatment must have started ≥12 weeks before screening. The medication dose must remain stable for ≥8 weeks before screening and throughout the screening period. Before cell infusion, other immunosuppressants (excluding hydroxychloroquine), including belimumab, telitacicept, CD20 monoclonal antibodies, or other biologic immunosuppressants, must be discontinued for at least 5 half-lives.\n5. Female participants of childbearing potential and male participants with female partners of childbearing potential must use medically approved contraceptive methods or practice abstinence during the study treatment period and for at least 6 months after the study. Female participants of childbearing potential must have a negative serum HCG test within 7 days before enrollment and must not be breastfeeding.\n6. Willing to participate in the trial and sign the informed consent form.\n\nDisease-Specific Inclusion Criteria:\n\nSystemic Lupus Erythematosus (SLE):\n\n1. Meets the 2019 EULAR\u002FACR classification criteria for SLE.\n2. ANA titer ≥1:80, or positive for anti-dsDNA and\u002For anti-Sm antibodies.\n3. Disease activity score (SLEDAI-2000) ≥8.\n\nSjögren's Syndrome:\n\n1. Meets the 2002 AECG criteria or the 2016 ACR\u002FEULAR classification criteria for primary Sjögren's syndrome.\n2. Disease activity score (ESSDAI) ≥5.\n3. Positive for anti-SSA\u002FRo antibodies.\n\nSystemic Sclerosis (SSc):\n\n1. Meets the 2013 EULAR\u002FACR classification criteria for systemic sclerosis.\n2. Classified by Leroy and Medsger as limited or diffuse cutaneous subsets.\n3. At screening, mRSS \\>10; and\u002For active interstitial lung disease (ILD), defined as: High-resolution computed tomography (HRCT) showing ground-glass opacities. Pulmonary function tests (FVC or DLCO) \\\u003C70% of predicted values.\n\nIdiopathic Inflammatory Myopathies (IIM):\n\n1. Meets the 2017 EULAR\u002FACR classification criteria for inflammatory myopathies (including dermatomyositis, polymyositis, antisynthetase syndrome, and necrotizing myopathy).\n2. For patients with muscle involvement: a. MMT-8 score \\\u003C142 and at least two abnormal findings among the following core measures: PhGA or PtGA scores ≥2. Extramuscular disease activity score ≥2. HAQ total score ≥0.25. Muscle enzyme levels ≥1.5 times the upper normal limit. b. Alternatively, MMT-8 ≥142 but with active ILD (HRCT showing ground-glass opacities).\n3. Positive for myositis-specific antibodies.\n\nANCA-Associated Vasculitis (AAV):\n\n1. Meets the 2022 ACR\u002FEULAR diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, or eosinophilic granulomatosis with polyangiitis.\n2. Positive for ANCA antibodies (current or historical).\n3. Birmingham Vasculitis Activity Score (BVAS) ≥15 (out of 63), indicating active vasculitis.\n\nExclusion Criteria:\n\n1. Subjects with a history of alcohol abuse or substance abuse within the past 24 weeks;\n2. Subjects with other psychiatric disorders such as schizophrenia or major depressive disorder;\n3. Subjects with a history of malignancies other than B-cell lymphoma;\n4. Subjects with overlapping diseases that affect the assessment of disease activity;\n5. Subjects with infections such as human immunodeficiency virus (HIV), hypogammaglobulinemia, T-cell deficiency virus infection, or chronic hepatitis B or C;\n6. Subjects with known active tuberculosis (TB) infection or bacterial infections;\n7. Subjects with a history of myocardial infarction, cardiac angioplasty or stent placement, unstable angina, active arrhythmia, or other clinically significant heart diseases within 6 months prior to screening;\n8. Subjects with a history of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to screening;\n9. Subjects with alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) levels ≥3×ULN, or bilirubin \\>1.5×ULN, excluding abnormalities caused by theautoimmune disease;\n10. Subjects with chronic kidney failure stage 4 or above, defined as an estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m² or serum creatinine \\>2.5 mg\u002FdL;\n11. At the screening visit, subjects with any of the following significant hematologic abnormalities caused by bone marrow suppression, excluding abnormalities due to the autoimmune disease:\n\n    1. Hemoglobin \\\u003C70 g\u002FL;\n    2. Absolute neutrophil count \\\u003C500\u002Fmm³;\n    3. Platelet count \\\u003C50,000\u002Fmm³;\n12. Subjects with a history of severe adverse reactions to cyclophosphamide or fludarabine;\n13. Subjects with a prior history of CAR-T therapy;\n14. Subjects who received live vaccines within 30 days prior to CAR-T cell infusion;\n15. Subjects deemed unsuitable for participation in the study by the investigator.",{"count":261,"type":21},[58,24],"Autoimmune diseases refer to a common category of diseases caused by the immune system reacting to self-antigens, leading to tissue damage. Autoimmune diseases encompass a wide variety of conditions, such as systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis, inflammatory myopathies, ANCA-associated vasculitis. Current treatments for autoimmune diseases include glucocorticoid, immunosuppressants, and biologics. B cell-driven humoral immune abnormalities are a central pathogenic mechanism in many autoimmune diseases. When autoreactive B cells are excessively activated, they produce large amounts of autoantibodies and immune complexes. These antibodies and immune complexes can cause damage to various tissues and organs, leading to the development of multiple autoimmune diseases. Therefore, targeting B cells to treat autoimmune diseases is an attractive therapeutic strategy. Clinical studies are exploring the use of CD19-targeting CAR-T cells for the treatment of autoimmune diseases, and their therapeutic efficacy has been demonstrated. In this study, we investigate the safety and efficacy of universal CD19-targeting CAR T cells in the treatment of autoimmune diseases.",[265,100,236,266,27],"2025-02-10",{"date":316,"type":39},"2025-02-12",{"date":318,"type":21},"2025-03-01",{"date":218,"type":21},{"name":220,"class":46},{"id":322,"slug":323,"hasResults":11,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":329,"targetDuration":4,"studyType":231,"phases":4,"briefSummary":331,"conditions":332,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":47},"100568368","ultrasonic-comparison-of-salivary-glands-in-autoimmune-diseases-cougar-100568368","NCT06680310","Ultrasonic COmparison of Salivary Glands in Autoimmune Diseases (COUGAR)","Prospective Multicenter Study of Ultrasound Evaluation of Salivary Glands in Patients with Sjögren's Disease Compared with Patients with Connective Tissue Diseases (lupus, Scleroderma, Rheumatoid Arthritis) and Healthy Subjects with Dry Syndromes","COUGAR","Inclusion Criteria:\n\n* Major patients\n* Patients fulfilling Sjogren criteria (2012 and 2016 American-European criteria) or Lupus according to ACR 2019 criteria or RA according to ACR\u002FEULAR 2010 criteria or scleroderma according to ACR-EULAR 2013 classification criteria or control patient (patient with dry syndrome felt without pre-cited autoimmune disease).\n\nExclusion Criteria:\n\n* Uncooperative patient who has refused to participate in the study.\n* Patients unable to understand the protocol, under guardianship or curatorship.\n* Patients not affiliated to the French Social Security system.",{"count":330,"type":21},501,"Prospective multicenter cross-sectional study evaluating ultrasound of the main salivary glands (2 parotid and 2 submandibular) in patients with Sjögren's disease compared with patients with other connective diseases (rheumatoid arthritis (RA), lupus, scleroderma) and control patients (patient with dry syndrome without the above-mentioned autoimmune disease).",[27,333,334,104,70],"Dry Syndrome","Lupus","2024-11-07",{"date":337,"type":39},"2024-11-08",{"date":339,"type":21},"2024-12-01",{"date":341,"type":21},"2025-12-01",{"name":343,"class":46},"University Hospital, Brest",{"id":345,"slug":346,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":350,"eligibilityCriteria":351,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":231,"phases":4,"briefSummary":354,"conditions":355,"keywords":357,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":47},"100565491","rare-autoimmune-self-management-programme-development-100565491","NCT06642870","Rare AutoImmune SElf-management Programme Development","Rare Autoimmune Self-management Programme Development","RAISE","Inclusion Criteria:\n\n1. Diagnosis of a rare rheumatic condition made by hospital doctor or secondary care: including lupus, systemic vasculitis, myositis, Sjogren syndrome (participant self-report)\n2. Ability to give informed consent (with translation support if needed)\n\nExclusion Criteria:\n\n\\-",{"count":353,"type":21},360,"The rare autoimmune rheumatic diseases (RAIRDs) are life-long multi-system diseases that are life or organ threatening. RAIRDs can impair quality of life similar to chronic diseases such as heart failure. The aim of the study is to explore content and structure of a support programme for people with RAIRDs in focus groups and survey meetings.",[265,356,209,100,266,27],"Systemic Vasculitis",[358,359,360],"Rare autoimmune rheumatic diseases","Self-management","Psychological support","2024-10-14",{"date":363,"type":39},"2024-10-15",{"date":365,"type":21},"2024-10",{"date":367,"type":21},"2026-04",{"name":369,"class":46},"University of the West of England"]