[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"iim\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:iim":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,64,92,136],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":35,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":63},"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",false,"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.","ALL","18 Years",{"count":19,"type":20},90,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","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.",[26,27,28,29,30,31,32,33,34],"Refractory Rheumatoid Arthritis (RA)","Idiopathic Inflammatory Myopathies (IIMs)","Systemic Sclerosis (SSc)","Rheumatoid Arthritis (RA","IIM","Myositis","Scleroderma","Sjogren Syndrome","Sjogrens Disease",[36,37,38,39,40,41,42,43,44,45,46,47,48,49,50],"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","RECRUITING","2026-05-20",{"date":54,"type":55},"2026-05-22","ACTUAL",{"date":57,"type":55},"2025-07-09",{"date":59,"type":20},"2029-01",{"name":61,"class":62},"Artiva Biotherapeutics, Inc.","INDUSTRY",52,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100575717","early-phase-1-clinical-study-on-targeted-cd19bcma-car-t-therapy-for-autoimmune-diseases-100575717","NCT06775912","Clinical Study on Targeted CD19\u002FBCMA 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 ≥1×109\u002FL, hemoglobin ≥60g\u002FL, platelet count ≥20×109\u002FL, lymphocyte count \\>0.3×109\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 RD06-04 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 RD06-04 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.","70 Years",{"count":72,"type":20},18,[74],"EARLY_PHASE1","This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with active SLE, SSc, AAV, IIM, NMOSD, MS, MG",[77,39,30,78,79,80,81],"SLE","NMOSD","MS","MG","ANCA Associated Vasculitis (AAV)","2026-01-30",{"date":84,"type":55},"2026-02-02",{"date":86,"type":55},"2025-01-03",{"date":88,"type":20},"2027-06-01",{"name":90,"class":62},"Nanjing Bioheng Biotech Co., Ltd.",1,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":100,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":103,"phases":4,"briefSummary":104,"conditions":105,"keywords":116,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":91},"100621706","mihra---patient-rooted-insights-for-shaping-myositis-science-prisms-100621706","NCT07374107","MIHRA - Patient-Rooted Insights for Shaping Myositis Science (PRISMS)","MIHRA - Patient-Rooted Insights for Shaping Myositis Science (PRISMS) - A Qualitative Study of Patient-voiced Research Priorities Across Rare Myositis Diseases","MIHRA-PRISMS","Inclusion Criteria:\n\n* Ability to provide informed consent\n* Have a clinician diagnosis of an idiopathic inflammatory myopathy or be a care partner or parent of a person living with an idiopathic inflammatory myopathy.\n* Participants who may have signed up through the MIHRA Patient Contact Registry https:\u002F\u002Fmihrafoundation.org\u002Fmihra-programs\u002Fmihra-patient-contact-registry\u002F\n\nExclusion Criteria:\n\n* Under the age of 7 years old\n* Do not have a diagnosis of an inflammatory myopathy","7 Years",{"count":102,"type":20},700,"OBSERVATIONAL","Myositis diseases are each rare diseases. As in other rare diseases, people living with myositis diseases face physical and psychosocial challenges that may not be recognized in current research priorities. The PRISMS study is a global investigation that collects patient perspectives through (mostly online) methods of open-ended questions, community forums and survey to identify the most pressing research concerns as identified by patients. Findings will be analyzed to create a patient-voiced set of research priorities that can guide the direction of research and help inform funding decisions across myositis diseases.\n\nPotential participants can express interest via https:\u002F\u002Fmihrafoundation.org\u002Fmihra-programs\u002Fmihra-patient-contact-registry\u002F",[106,30,31,107,108,109,110,111,112,113,114,115],"IBM","Inflammatory Myopathy","Dermatomyositis","Dermatomyositis, Juvenile","Anti-synthetase Syndrome","Immune-Mediated Necrotizing Myopathy","Polymyositis","Inclusion Body Myositis","Juvenile Myositis","Juvenile Dermatomyositis",[117,118,119,120,121,122,123,124,125],"myositis","rare diseases","patient priorities","patient engagement","patient initiated","patient research partners","qualitative research","mixed methods research","research priorities","2026-01-20",{"date":128,"type":55},"2026-01-28",{"date":130,"type":55},"2025-06-25",{"date":132,"type":20},"2030-12",{"name":134,"class":135},"Myositis International Health & Research Collaborative Alliance Foundation","OTHER",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":143,"enrollmentInfo":144,"targetDuration":4,"studyType":21,"phases":146,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":91},"100608580","early-phase-1-a-study-of-anti-cd19bcma-universal-car-t-cell-therapy-rd06-05-in-patients-with-autoimmune-diseases-100608580","NCT07203404","A Study of Anti-CD19\u002FBCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.","A Clinical Study of the Safety, Efficacy, and Cell Pharmacokinetics of Anti-CD19\u002FBCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent.\n2. Aged ≥18 years and ≤75 years.\n3. Adequate organ function defined as:\n\n   1. Bone marrow function: Defined as absolute neutrophil count (ANC) ≥1500\u002FμL, absolute lymphocyte count (ALC) ≥100\u002FμL, hemoglobin (Hb) ≥80 g\u002FL, and platelet count (PLT) ≥50,000\u002FμL. Transfusions and growth factors must not have been used within 7 days prior to screening to meet these criteria.\n   2. Liver function: Defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × upper limit of normal (ULN), and total bilirubin \\\u003C1.5 × ULN (or \\\u003C3.0 × ULN for subjects with Gilbert's syndrome).\n   3. Coagulation function: Defined as international normalized ratio (INR) or partial thromboplastin time (PTT) ≤1.5 × ULN.\n   4. Pulmonary function: Defined as dyspnea ≤ Grade 1 per CTCAE and oxygen saturation (SpO₂) ≥92% on room air (by pulse oximetry).\n4. Female subjects of childbearing potential must have a negative serum or urine pregnancy test. Females who are surgically sterile or postmenopausal for at least 2 years are considered not of childbearing potential.\n5. From the time of signing the informed consent form until 6 months after the completion of RD06-05 infusion, female subjects of childbearing potential and male subjects with partners of childbearing potential must use highly effective methods of contraception.\n\nInclusion Criteria for Subjects with Anti-GBM Disease:\n\nDiagnosis of anti-GBM disease according to the 2012 Chapel Hill Consensus Conference definitions, meeting both of the following criteria:\n\n1. Positive for anti-GBM antibody (based on historical or screening test results);\n2. Evidence of renal involvement at screening, defined as:\n\n   1. Presence of active, pathologically confirmed anti-GBM disease (renal biopsy must have been performed within 1 year prior to the screening visit or during the screening period); and\n   2. Accompanied by proteinuria and hematuria.\n\nInclusion Criteria for Subjects with SLE\u002FLN:\n\n1. Diagnosis of SLE according to the 2019 European Alliance of Associations for Rheumatology (EULAR)\u002FAmerican College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria.\n2. Positive for antinuclear antibody (ANA), and\u002For anti-double-stranded DNA (anti-dsDNA) antibody, and\u002For anti-Smith (anti-Sm) antibody at screening.\n3. SLEDAI-2K score \\> 6 points at screening.\n\nInclusion Criteria for Subjects with AAV\u002FAAGN:\n\n1. Diagnosis of microscopic polyangiitis (MPA) or granulomatosis with polyangiitis (GPA) according to the 2022 ACR\u002FEULAR classification criteria for ANCA-associated vasculitis.\n2. Positive for anti-myeloperoxidase (MPO-ANCA) antibody or anti-proteinase 3 (PR3-ANCA) antibody at screening or based on historical testing.\n3. For AAV without renal involvement: A Birmingham Vasculitis Activity Score (BVAS) version 3 score of ≥3 at screening, indicating active vasculitis.\n\nInclusion Criteria for Subjects with MN:\n\n1. Diagnosis of primary (idiopathic) membranous nephropathy confirmed by renal biopsy pathology (the renal biopsy must have been performed within 2 years prior to screening or during the screening period).\n2. Meeting the criteria for high-risk or relapsed\u002Frefractory membranous nephropathy:\n\nHigh-risk patients, defined as meeting any of the following criteria:\n\n1. Normal eGFR with urine protein \\>3.5g\u002F24h, a reduction of \\\u003C50% in urine protein after 6 months of ACEI\u002FARB treatment, and serum albumin \\\u003C25 g\u002FL or anti-PLA2R antibody \\>50 RU\u002FmL;\n2. eGFR \\\u003C60 mL\u002Fmin\u002F1.73m² and\u002For urine protein \\>8g\u002F24h for more than 6 months.\n\nRefractory\u002FRelapsed patients:\n\nRefractory patients are defined as those resistant to prior immunosuppressive therapy (persistent urine protein ≥3.5g\u002F24h with a \\\u003C50% reduction from baseline).\n\nRelapsed patients are defined as those who achieved complete or partial remission with prior immunosuppressive therapy but subsequently developed recurrent urine protein ≥3.5g\u002F24h.\n\nInclusion Criteria for Subjects with SSC:\n\n1. Diagnosis of systemic sclerosis (SSc) according to the 2013 American College of Rheumatology (ACR)\u002FEuropean Alliance of Associations for Rheumatology (EULAR) classification criteria.\n2. Diagnosis of diffuse cutaneous SSc at screening.\n\nInclusion Criteria for Subjects with IIM:\n\n1.Diagnosis of idiopathic inflammatory myopathy (IIM) according to the 2017 ACR\u002FEULAR classification criteria (including probable or definite diagnosis, corresponding to a probability score of ≥55%). The subtypes include dermatomyositis (DM), anti-synthetase syndrome (ASS), and immune-mediated necrotizing myopathy (IMNM).\n\nExclusion Criteria:\n\n1. Subjects with SLE\u002FLN:\n\n   1. Severe active central nervous system (CNS) lupus, including psychosis, seizures, lupus headache, or other signs\u002Fsymptoms associated with neuropsychiatric lupus, as assessed by a qualified specialist during screening.\n   2. Drug-induced or secondary lupus.\n2. Subjects with AAV\u002FAAGN:\n\n   1. Drug-induced or secondary AAV\u002FAAGN.\n   2. Presence of alveolar hemorrhage requiring invasive ventilatory support at screening.\n3. Subjects with Anti-GBM Disease:\n\n   1. Anuria for more than 7 days.\n   2. Dialysis dependence for more than 30 days.\n   3. Ongoing moderate or severe pulmonary hemorrhage (or cessation within the past two weeks) defined as pulmonary hemorrhage requiring assisted ventilation, supplemental oxygen, or blood transfusion.\n   4. Symptomatic congestive heart failure (NYHA Class 2-4) requiring prescription medication or clinically significant cardiogenic peripheral edema.\n4. Subjects with MN:\n\n   Secondary membranous nephropathy.\n5. Subjects with IIM:\n\n   Presence of severe rhabdomyolysis or CK level ≥120 × ULN at screening.\n6. Subjects with SSc:\n\n   1. History of scleroderma renal crisis within 1 year prior to screening.\n   2. History of cardiac tamponade within 6 months prior to screening.\n   3. Active infection of digital ulcers within 3 months prior to screening.\n   4. Presence of digital gangrene at screening.","75 Years",{"count":145,"type":20},84,[74],"An Exploratory, Single-Arm, Open-Label, Dose-Escalation Study of the Safety, Tolerability, PK, PD, and Efficacy of Anti-CD19\u002FBCMA Universal CAR-T Therapy RD06-05 in Autoimmune Diseases (including SLE\u002FLN, AAV\u002FAAGN, Anti-GBM, MN, SSc, and IIM).",[77,149,150,151,152,153,154,30],"LN","ANCA Associated Vasculitis","ANCA-Associated Glomerulonephritis","Anti-GBM Disease","MN","SSc","2025-09-23",{"date":157,"type":55},"2025-10-02",{"date":159,"type":55},"2025-07-24",{"date":161,"type":20},"2028-07-23",{"name":90,"class":62}]