[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myasthenia-gravis-mg\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myasthenia-gravis-mg":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,42,74,100,129,155,175,200,236,256,277,305],{"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":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100645049","sexual-and-urinary-dysfunctions-in-generalized-myasthenia-100645049",false,"NCT07677852","Sexual and Urinary Dysfunctions in Generalized Myasthenia","Sexual and Urinary Dysfunctions in Generalized Myasthenia: Impact on Quality of Life - the MYAOUS Study","MYAOUS","Inclusion Criteria:\n\n1. Minimum age of 18 years at the time the informed consent form is obtained.\n2. Confirmed diagnosis of generalized autoimmune myasthenia gravis, including at least two of the following:\n\n   1. Typical clinical features assessed by a physician specializing in myasthenia gravis\n   2. A decrease of ≥ 10% during repeated nerve stimulation (3-5 Hz) or increased irregularity on a single-fiber electromyogram\n   3. A positive edrophonium test or response to anticholinesterase agents\n   4. Serum anti-AChR or anti-MuSK antibodies.\n3. Enrolled in or covered by a social security program in accordance with current regulations governing research involving human subjects.\n\nExclusion Criteria:\n\n1. Pregnant (at the time of enrollment)\n2. Postpartum \\\u003C 6 months\n3. Severe cognitive impairment or under legal guardianship, making it impossible to understand or complete self-administered questionnaires.","ALL","18 Years",{"count":20,"type":21},150,"ESTIMATED","OBSERVATIONAL","Myasthenia gravis is an autoimmune disease caused by specific autoantibodies that disrupt the function of the neuromuscular junction. It manifests as excessive fatigue of the skeletal muscles during physical exertion and affects 15,000 people in France. Initial symptoms are most often ocular (ptosis, diplopia) but can later spread throughout the body, potentially leading in some cases to respiratory failure and\u002For swallowing difficulties (myasthenic crisis) or even death. This condition is currently being managed more effectively through treatment, and the invisible symptoms (sexual dysfunction, sphincter dysfunction, psychological impact, etc.) may ultimately be more debilitating than the initial symptoms, which are often controlled by maintenance and\u002For symptomatic treatments. The impact of myasthenia gravis on intimate life remains a taboo subject and is poorly understood by both the medical community and patients. In the literature, only a single article from 2021 addresses sexual dysfunction in patients with myasthenia gravis. Urinary disorders in myasthenia gravis are frequently reported but have also been little studied.\n\nA national survey, conducted using an online questionnaire distributed by patient associations, shed light on the disease's impact on patients' intimate lives. In this study of 190 patients, 46 of them responded to the question about sexual function, and one in two patients reported sexual complaints; in 46% of cases, this disorder significantly impacted the patients' daily lives. In particular, a decrease in the frequency of sexual intercourse with a partner was noted in 55% of cases, as well as a decrease in sexual desire in 51% of cases.\n\nSexual dysfunction is very common and underreported in many chronic neurological diseases. The Sexual Complaints Screener (SCS W\u002FM) questionnaires for women and men in English have very recently been validated in French (Questionnaires de Plaintes Sexuelles, QPS F\u002FH).\n\nIt now have a 10-item self-administered questionnaire that assesses the full range of sexual disorders and their impact.\n\nIn conclusion, while the visible symptoms of myasthenia gravis are widely recognized, the invisible symptoms-such as genitourinary and sphincter disorders-remain largely unrecognized and underdiagnosed. It is therefore essential to conduct systematic screening in order to best guide our patients and thereby improve their quality of life.",[25],"Myasthenia Gravis (MG)",[27,28],"genitourinary and sphincter disorders","Myasthenia gravis","NOT_YET_RECRUITING","2026-06-26",{"date":32,"type":33},"2026-07-01","ACTUAL",{"date":35,"type":21},"2026-07-30",{"date":37,"type":21},"2030-07-30",{"name":39,"class":40},"Centre Hospitalier Universitaire de Nice","OTHER",2,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":62,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100644891","phase-1-a-study-of-c-car168-in-the-treatment-of-autoimmune-diseases-refractory-to-standard-therapy-100644891","NCT07676266","A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy","An Exploratory Clinical Study of Anti-CD20\u002FB-cell Maturation Antigen (BCMA) Chimeric Antigen Receptor Autologous T Cell Product (C-CAR168) in the Treatment of Autoimmune Diseases Refractory to Standard Therapy","Inclusion Criteria:\n\n* 18 to 70 years old at the time of signing the Informed Consent Form (ICF).\n* Diagnosed as Multiple sclerosis (MS)\u002FNeuromyelitis Optica Spectrum Disorders (NMOSD)\u002FMyasthenia Gravis (MG)\u002FSystemic Lupus Erythematosus (SLE)\u002F Systemic Sclerosis (SSc)\u002F Immune-Mediated Necrotizing Myopathy (IMNM) according to recognized diagnostic criteria for at least 6 months.\n* Prior treatment failure with standard therapy.\n* Adequate bone marrow, coagulation, cardiopulmonary, liver and renal function.\n\nExclusion Criteria:\n\n* Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Treponema Pallidum (TP) positive, Cytomegalovirus (CMV) DNA positive, Epstein-Barr Virus (EBV) DNA positive.\n* Uncontrolled active infection.\n* Live vaccine injection within 4 weeks prior to signing the ICF.\n* Major organ transplantation history or bone marrow\u002Fhematopoietic stem cell transplantation history.\n* Severe cardiovascular diseases within the past 6 months prior to screening.\n* A history of ≥ Grade 2 bleeding within 4 weeks prior to screening, or requiring long-term anticoagulants treatment.\n* Inadequate washing time for previous treatment.\n* Previously treated with CAR-T cell products or genetically modified T cell therapies.\n* Pregnant or lactating women.\n* Severe central nervous system diseases or pathological changes.\n* Malignancy history within 5 years prior to signing the ICF.\n* Any contraindication to lumbar puncture for MS or NMOSD.","70 Years",{"count":51,"type":21},18,"INTERVENTIONAL",[54],"PHASE1","This is an investigator-initiated, single-center, open-label study of C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, for the treatment of adult patients with autoimmune diseases refractory to standard therapy",[57,25,58,59,60,61],"Multiple Sclerosis (MS)","Neuromyelitis Optica Spectrum Disorder","Systemic Lupus Erythematosus","Systemic Sclerosis","Immune-Mediated Necrotizing Myopathy",[63],"CD20\u002FBCMA-directed CAR-T cells","2026-06-24",{"date":66,"type":33},"2026-06-30",{"date":68,"type":21},"2026-07",{"date":70,"type":21},"2028-10",{"name":72,"class":40},"The Affiliated Hospital of Qingdao University",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":52,"phases":84,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":95,"leadSponsor":97,"locationsCount":4},"100644739","phase-2-adapt-forward-2---isa2---a-study-to-evaluate-the-safety-tolerability-and-efficacy-of-empasiprubart-iv-monotherapy-in-participants-with-achr-ab-seropositive-generalized-myasthenia-gravis-100644739","NCT07673627","ADAPT Forward 2 - ISA2 - a Study to Evaluate the Safety, Tolerability and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis","ISA2 to Master Protocol ARGX-999-2-MG-2000 - an Exploratory, Phase 2a, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis","ADAPT Forward2","Inclusion Criteria:\n\n* Is seropositive for anti-acetylcholine receptor antibodies (AChR-Ab).\n* Has confirmed diagnosis of gMG and is Myasthenia Gravis Foundation of America (MGFA) Class II, III, IVa, or IVb.\n* Has documented immunization against encapsulated bacterial pathogens (Neisseria meningitidis and Streptococcus pneumoniae) within 5 years before ISA screening or will complete immunization at least 14 days before the first IMP administration.\n\nExclusion Criteria:\n\n* Clinical diagnosis of systemic lupus erythematosus (SLE).\n* Is receiving concurrent complement inhibitors (eg, eculizumab, zilucoplan, ravulizumab, or others). Participants who received zilucoplan or eculizumab \\>2 months or ravulizumab \\>6 months before baseline are allowed to participate.\n* Has received an FcRn antagonist, including efgartigimod, within 4 weeks before baseline.\n* Had prior empasiprubart exposure.",{"count":83,"type":21},40,[85],"PHASE2","This study is part of the ADAPT Forward platform study (NCT07294170). ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis. The goal is to find the best therapeutic approach to reduce patients' side effects and improve their quality of life.\n\nThe aim of this ISA2 is to investigate the effects of empasiprubart in participants with AChR-Ab seropositive generalized myasthenia gravis (gMG).\n\nThe ADAPT Forward master protocol is registered on https:\u002F\u002Fclinicaltrials.gov\u002Fstudy\u002FNCT07294170",[88,25,89,90],"AChR-Ab Seropositive Generalized Myasthenia Gravis","MG - Myasthenia Gravis","gMG","2026-06-23",{"date":93,"type":33},"2026-06-29",{"date":93,"type":21},{"date":96,"type":21},"2028-04",{"name":98,"class":99},"argenx","INDUSTRY",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":52,"phases":111,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":73},"100637500","a-study-to-evaluate-mtm-h-001-injection-in-adult-patients-with-b-cell-related-autoimmune-diseases-100637500","NCT07593911","A Study to Evaluate MTM-H-001 Injection in Adult Patients With B-Cell-Related Autoimmune Diseases","An Open-Label, Single-Arm, Dose-Escalation and Expansion Basket Study Evaluating the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Efficacy of MTM-H-001 in Patients With B-Cell-Related Autoimmune Diseases (ArchAid-002)","ArchAid-002","Inclusion Criteria:\n\n* Key inclusion criteria include：\n\n  1. Male or female, aged 18 - 75 years old (inclusive);\n  2. The participant or his\u002Fher legally acceptable representative gives consent to this clinical study participation and signs an Informed Consent Form (ICF) indicating their understanding of the objectives and procedures of the clinical study and willingness to participate in the study;\n  3. Confirmed diagnosis of the target autoimmune disease per international classification criteria;\n  4. Adequate organ function to tolerate treatment;\n  5. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and agree to use at least one effective contraceptive method throughout the study and within 6 months after the last treatment cycle.\n\nExclusion Criteria:\n\n* Key exclusion criteria include:\n\n  1. Active, severe, uncontrolled infection;\n  2. Pregnancy or breastfeeding women;\n  3. History of malignancy within the protocol-defined period, except adequately treated low-risk cancers;\n  4. Any condition that, in the investigator's opinion, would compromise safety, compliance, or interpretability of study data.","75 Years",{"count":110,"type":21},75,[112],"NA","This is an investigator-initiated, open-label, single-arm, dose-escalation and dose-expansion study to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of MTM-H-001 in adult participants with B-cell-related autoimmune diseases.",[115,116,117,25,118,119],"Systemic Lupus Erthematosus (SLE)","Lupus Nephritis (LN)","Multiple Sclerosis","IgG4-Related Diseases","Rheumatoid Arthritis (RA)","2026-05-12",{"date":122,"type":33},"2026-05-18",{"date":124,"type":21},"2026-06",{"date":126,"type":21},"2031-06",{"name":128,"class":40},"Beijing GoBroad Hospital",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":108,"enrollmentInfo":136,"targetDuration":4,"studyType":52,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":73},"100633423","phase-1-safety-and-pharmacodynamics-of-qh103-cell-injection-in-the-treatment-of-patients-with-relapsedrefractory-antibody-mediated-neurological-autoimmune-diseases-100633423","NCT07526493","Safety and Pharmacodynamics of QH103 Cell Injection in the Treatment of Patients With Relapsed\u002FRefractory Antibody-Mediated Neurological Autoimmune Diseases.","An Open-Label Clinical Study to Evaluate the Safety and Pharmacodynamics of QH103 Cell Injection in the Treatment of Patients With Relapsed\u002FRefractory Antibody-Mediated Neurological Autoimmune Diseases.","Common Inclusion Criteria:\n\n1. Aged 18-75 years (inclusive), any gender.\n2. Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or practice abstinence during the study treatment period and for at least 6 months after the end of the study treatment. Female subjects of childbearing potential must have a negative serum HCG test within 7 days before study enrollment and must not be breastfeeding.\n3. The subject's expected survival, as judged by the investigator, is ≥12 weeks.\n4. Voluntarily participate in this trial and sign the informed consent form.\n\nDisease-Specific Inclusion Criteria:\n\n1、Multiple Sclerosis (MS): Clinically confirmed as progressive MS (including Primary Progressive PPMS or Secondary Progressive SPMS) or Relapsing-Remitting MS (RMS) according to the revised 2017 McDonald criteria. Disability status at screening must meet an EDSS score of 2-7 (inclusive) .For participants with RMS, despite standardized use of DMTs, they must have documented evidence meeting one of the following conditions prior to signing the informed consent:\n\n1. Two relapses were recorded within the first 2 years of screening;\n2. One recurrence was recorded within the first year prior to screening;\n3. Select the results of Gd-enhanced MRI scans that were positive within the previous year (if there is no record of a positive Gd-enhanced scan in the previous year, the results of the screening MRI scan can be used).\n\n2、Neuromyelitis Optica Spectrum Disorder (NMOSD): Participants with AQP4 antibody-positive NMOSD meeting the 2015 IPND NMOSD diagnostic criteria, and meeting one of the following:\n\n1. Treatment with at least one immunosuppressant for over 1 year, or intolerance to immunosuppressant treatment, with suboptimal symptom control.\n2. At least 2 documented relapses within the last 12 months, or 3 documented relapses within the last 24 months with at least 1 relapse occurring within the 12 months prior to screening.\n\n3、Autoimmune Encephalitis (AE): Participants with a clinical diagnosis of Autoimmune Encephalitis based on the 2016 International Diagnostic Criteria, meeting all of the following requirements:\n\n1. Positive for at least one relevant autoantibody;\n2. Inadequate symptom control with or intolerance to previous standardized treatment with glucocorticoids and at least one immunosuppressant\u002Fimmunomodulator (including CD20 monoclonal antibody);\n3. An episode of autoimmune encephalitis within 3 months prior to signing the informed consent form;\n4. Disability status at screening meeting a modified Rankin Scale (mRS) score ≥ 2 or a CASE score ≥ 4 .\n\n4、Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): Participants diagnosed with antibody-positive CIDP according to the 2021 EAN\u002FPNS diagnostic criteria, with an INCAT Disability Scale total score between 2 and 9, and meeting one of the following:\n\n1. Inadequate symptom control despite standardized use of at least one first-line therapy (corticosteroids, intravenous immunoglobulin, or plasma exchange) for over 3 months;\n2. Intolerance to corticosteroids, intravenous immunoglobulin, and plasma exchange due to side effects or other reasons.\n\n5、Myasthenia Gravis (MG): Participants diagnosed with antibody-positive MGFA Class II-IV Myasthenia Gravis according to the 2020 MGFA diagnostic criteria, with a Myasthenia Gravis Activities of Daily Living (MG-ADL) profile (Appendix 6) total score ≥ 6, and meeting one of the following:\n\n1. Standardized treatment with at least one immunosuppressant for over 1 year, with one of the following indicating inadequate control: (1) persistent weakness affecting daily life, (2) worsening MG symptoms and\u002For crisis episodes despite standard treatment, or (3) intolerance to immunosuppressant therapy;\n2. Requiring maintenance therapy with plasma exchange or intravenous immunoglobulin.\n\n6、Anti-Myelin Oligodendrocyte Glycoprotein Immunoglobulin G Antibody----- - Associated Disease (MOGAD): Participants with a clinical diagnosis of MOGAD based on the 2023 International MOGAD Diagnostic Criteria, meeting all of the following:\n\n1. Positive for MOG autoantibody via cell-based assay (CBA);\n2. Disability status at screening meeting a modified Rankin Scale (mRS) score ≥ 2.\n3. Inadequate symptom control with or intolerance to previous standardized treatment with glucocorticoids and at least one immunosuppressant \u002F immunomodulator (including CD20 monoclonal antibody).\n\n7、Idiopathic Inflammatory Myopathies (IIM): Patients clinically diagnosed with refractory, antibody-positive Idiopathic Inflammatory Myopathy (IIM) based on the 2017 European Alliance of Associations for Rheumatology\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria. At screening, at least one muscle enzyme (CK, AST, ALT, ALD, LDH) must be ≥1.5 times the upper limit of normal (ULN); OR the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) for dermatomyositis must be ≥6 (Appendix 7); OR there must be evidence of active myositis within the last 6 months from at least one of the following: MRI, electromyography, or muscle biopsy. The patient must test positive for at least one myositis-specific antibody (MSA), myositis-associated antibody (MAA), or antinuclear antibody (ANA). Additionally, they must meet one of the following criteria:\n\n1. Treatment with corticosteroids for at least 1 month, combined with standardized use of at least one immunosuppressant\u002Fimmunomodulator (e.g., azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, tacrolimus, cyclophosphamide, leflunomide, intravenous immunoglobulin, etc.) for over 3 months, resulting in inadequate symptom control.\n2. Intolerance to the aforementioned conventional treatment regimens due to side effects or other reasons.\n\nExclusion Criteria:\n\n1. History of severe drug allergy or allergic diathesis.\n2. Presence of or suspected uncontrolled or treatment-requiring fungal, bacterial, viral, or other infections.\n3. Organ function that does not meet the following requirements (except for abnormalities caused by the autoimmune disease itself):\n\n   1. Bone Marrow Function: White blood cell count ≥1×10⁹\u002FL; absolute neutrophil count ≥1×10⁹\u002FL (no treatment with colony-stimulating factors within 2 weeks prior to the test); hemoglobin ≥60 g\u002FL.\n   2. Liver Function: ALT ≤3×ULN (except if elevated due to inflammatory myopathy); AST ≤3×ULN (except if elevated due to inflammatory myopathy); Indirect bilirubin (IBIL) ≤1.5×ULN (except for Gilbert's syndrome); Total bilirubin ≤3.0×ULN.\n   3. Renal Function: Creatinine clearance (CrCl) ≥30 mL\u002Fmin (eGFR ≥30 mL\u002Fmin\u002F1.73m²) (calculated by Cockcroft-Gault formula, except for acute decreases in CrCl due to the disease itself).\n   4. Coagulation Function: International normalized ratio (INR) ≤1.5×ULN; Prothrombin time (PT) ≤1.5×ULN.\n   5. Cardiac Function: Left ventricular ejection fraction (LVEF) ≥55% and no clinically significant cardiac disease.\n4. Subjects with a history indicative of congenital immunoglobulin deficiency.\n5. History of active\u002Funresolved malignant tumors within the past 5 years.\n6. Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titer above the detection limit; positive for hepatitis C virus (HCV) antibody with detectable peripheral blood HCV RNA; positive for human immunodeficiency virus (HIV) antibody; or positive for Treponema pallidumserology.\n7. History of definite psychiatric disorders or history of substance abuse involving psychotropic drugs that cannot be discontinued.\n8. Participation in any other clinical trial within 3 months prior to enrollment.\n9. Prior treatment with CAR-T cell therapy.\n10. History of severe adverse reactions to cyclophosphamide or fludarabine.\n11. History of other autoimmune diseases (e.g.,Crohn's disease, systemic lupus erythematosus) that, within the past 2 years, have resulted in end-organ damage or required systemic immunosuppressive therapy (excluding the disease populations specified for enrollment in the study protocol).\n12. Myasthenia gravis crisis not effectively controlled within 2 weeks prior to enrollment.\n13. History of cerebrovascular accident, including transient ischemic attack or stroke, within 6 months prior to enrollment.\n14. Male or female participants unwilling to practice contraception from the time of informed consent until 6 months after treatment completion.\n15. Any medical condition that may interfere with the assessment of the safety or efficacy of the study treatment.\n16. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment, requiring systemic anticoagulation therapy.\n17. Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study.",{"count":137,"type":21},6,[54],"This study is an open-label, exploratory, prospective clinical trial with dose escalation(according to \"3+3\" design), to evaluate the safety and tolerability of QH103(Universal CD19 CAR-γδT Cell Injection)in the treatment of recurrent\u002Frefractory antibody-mediated neurological autoimmune diseases.",[57,141,142,143,25,144,145],"Neuromyelitis Optica Spectrum Disorder (NMOSD)","Autoimmune Encephalitis (AE)","Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","Anti-Myelin Oligodendrocyte Glycoprotein Immunoglobulin G Antibody-Associated Disease (MOGAD)","Idiopathic Inflammatory Myopathies (IIM)","RECRUITING","2026-05-07",{"date":120,"type":33},{"date":150,"type":33},"2026-04-01",{"date":152,"type":21},"2028-12-31",{"name":154,"class":40},"Tongji Hospital",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":162,"targetDuration":4,"studyType":52,"phases":164,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":73},"100618912","early-phase-1-cd19bcma-targeted-ucar-t-for-patients-with-neurological-autoimmune-diseases-100618912","NCT07337785","CD19\u002FBCMA-Targeted UCAR-T for Patients With Neurological Autoimmune Diseases","Clinical Study on the Safety, Efficacy, and Pharmacokinetics of Universal CAR-T Cell Injection Targeting CD19\u002FBCMA in Patients With Neurological Autoimmune Diseases","General Inclusion Criteria for All Participants:\n\n1. Patients voluntarily agree to participate in this trial and sign the informed consent form.\n2. Aged ≥ 18 years and ≤ 70 years, regardless of gender.\n3. Organ function and laboratory test requirements:\n\n   1. Liver function: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3 × Upper Limit of Normal (ULN); Total Bilirubin (TBIL) ≤ 2 × ULN (except for patients with Gilbert's syndrome).\n   2. Renal function: Serum creatinine ≤ 1.5 × ULN OR creatinine clearance rate ≥ 40 ml\u002Fmin.\n   3. Complete blood count: Neutrophil count ≥ 1 × 10⁹\u002FL; hemoglobin ≥ 60 g\u002FL; platelet count ≥ 20 × 10⁹\u002FL; lymphocyte count \\> 0.3 × 10⁹\u002FL.\n   4. Coagulation function: International Normalized Ratio (INR) ≤ 1.5 × ULN OR Prothrombin Time (PT) ≤ 1.5 × ULN.\n   5. Oxygen saturation (SpO₂) ≥ 92% at rest while breathing room air.\n   6. Echocardiography shows Left Ventricular Ejection Fraction (LVEF) ≥ 50%.\n4. For female patients of childbearing potential at screening, the result of serum or urine pregnancy test is negative.\n5. Female of childbearing potential must use effective contraception from at least 28 days before apheresis until 12 months after RD06-05 infusion. Male of reproductive potential must use effective barrier contraception during the same period and must not donate semen or sperm throughout the study.\n\nSpecific Inclusion Criteria for Patients with MS:\n\n1. Diagnosed as Relapsing-Remitting Multiple Sclerosis (RRMS), Primary Progressive Multiple Sclerosis (PPMS), or Secondary Progressive Multiple Sclerosis (SPMS) by a neurologist with diagnostic and treatment qualifications in accordance with the 2017 Revised McDonald Criteria, and relevant diagnostic documents must be provided.\n2. Expanded Disability Status Scale (EDSS) score ranging from 3.0 to 7.5 (inclusive of the cutoff values).\n3. Having undergone a brain MRI examination that meets the 2017 McDonald Criteria within 12 months prior to screening (must include T2\u002FFLAIR and gadolinium-enhanced T1 sequences), showing spatial multiplicity (≥ 2 typical MS lesion regions) and\u002For temporal multiplicity (new T2 or gadolinium-enhanced \\[Gd+\\] lesions).\n4. Previous cerebrospinal fluid (CSF) examination or CSF examination report during the screening period indicating at least one of the following conditions:\n\n   1. Elevated IgG index\n   2. Detection of one or more IgG oligoclonal bands (OCB)\n5. Having received high-efficacy disease-modifying therapy (DMT) for at least 6 months, with the occurrence of any of the following conditions during the treatment period:\n\n   1. Clinically confirmed relapse by a neurologist (new or recurrent persistent neurological deficit lasting ≥ 24 hours, excluding other causes such as fever\u002Finfection)\n   2. EDSS progression (defined as: an increase of ≥ 1.0 point if EDSS ≤ 5.5; or an increase of ≥ 0.5 point if EDSS \\> 5.5) High-efficacy DMTs include but are not limited to: anti-CD20 monoclonal antibodies (e.g., Ocrelizumab), lymphocyte-depleting therapies (e.g., Alemtuzumab, Cladribine), and α4 integrin blockers (e.g., Natalizumab).\n6. RRMS patients must meet one of the following criteria: at least 1 documented relapse within 1 year prior to screening, or at least 2 documented relapses within 2 years prior to screening, or brain MRI indicating active gadolinium-enhanced lesions or new T2 lesions within 1 year prior to screening. PPMS or SPMS patients must have documented evidence of disability progression within 2 years prior to screening. All relapses or MRI activity must be supported by medical records (e.g., outpatient\u002Finpatient records, MRI reports, EDSS assessment forms).\n\nSpecific Inclusion Criteria for Patients with MG:\n\n1. Meet the diagnostic criteria for generalized myasthenia gravis (gMG) in line with international myasthenia gravis (MG) consensus guidelines (e.g., the 2020 Myasthenia Gravis Foundation of America \\[MGFA\\] Guidelines).\n2. Classified as MGFA Clinical Class II, III, or IV (per the MGFA Clinical Classification system for myasthenia gravis).\n3. Serological testing at screening shows positivity for acetylcholine receptor antibodies (AChR-Ab), muscle-specific tyrosine kinase antibodies (MuSK-Ab), or low-density lipoprotein receptor-related protein 4 antibodies (LRP4-Ab); or there is a documented history of positivity for AChR-Ab, MuSK-Ab, or LRP4-Ab in previous medical records.\n4. Score of ≥ 6 points on the Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale, with the score related to ocular symptoms accounting for less than 50% of the total score.\n5. Score of ≥ 8 points on the Quantitative Myasthenia Gravis (QMG) Score, with ≥ 4 items each scoring at least 2 points.\n6. Having received at least one of the following treatments prior to screening, with relevant medical documentation provided:\n\n   1. Immunosuppressants (including but not limited to azathioprine, mycophenolate mofetil, methotrexate, cyclosporine, tacrolimus, cyclophosphamide, etc.)\n   2. Biologic agents (including but not limited to complement C5 inhibitors, FcRn blockers, etc.).\n7. As judged by the investigator, the subject has received stable current treatment for MG for at least 3 months and has experienced any of the following:\n\n   1. An increase of ≥ 2 points in the total MG-ADL score, with an increase of ≥ 1 point in non-ocular items;\n   2. An increase of ≥ 3 points in the total QMG score, or an increase of ≥ 1 point in each of ≥ 2 non-ocular muscle items;\n   3. Need for increased medication dosage, hospitalization, or emergency intervention due to MG exacerbation.\n\nDefinition of \"stable treatment\":\n\ni). If the subject is taking acetylcholinesterase inhibitors, they must have received treatment with a stable dosage and regimen for at least 2 weeks prior to screening; ii). If the subject is using glucocorticoids, they must have received treatment with a stable dosage and regimen for at least 2 weeks prior to screening; iii). If the subject is receiving biologics, complement inhibitors, or FcRn blockers, they must have received treatment with a stable dosage for at least 4 weeks prior to screening; iv). If the subject is receiving other immunosuppressants or small-molecule targeted therapeutic agents, they must have received treatment with a stable dosage for at least 2 weeks prior to screening; v). If glucocorticoids and\u002For immunosuppressants were discontinued prior to screening due to intolerance or lack of efficacy, the discontinuation must have occurred at least 4 weeks before screening.\n\nSpecific Inclusion Criteria for Patients with CIDP:\n\n1. Diagnosed as progressive or relapsing chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) or meeting the criteria for possible CIDP in accordance with the 2021 Guidelines of the European Academy of Neurology (EAN)\u002FPeripheral Nerve Society (PNS), with supporting evidence including at least the following: electrophysiological findings (slowed nerve conduction velocity in ≥ 2 nerves + conduction block\u002Ftemporal dispersion), elevated cerebrospinal fluid (CSF) protein level (\\> 45 mg\u002FdL), nerve root thickening on MRI, or nerve biopsy results (if applicable).\n2. CIDP Disease Activity Status (CDAS) score ≥ 2 at screening.\n3. Inflammatory Neuropathy Cause and Treatment (INCAT) score ≥ 2 at screening: For patients with an INCAT score of 2, the score must be entirely from lower limb function; for patients with an INCAT score ≥ 3, there is no requirement on whether the score comes from upper or lower limbs.\n4. Having received any of the following treatments for at least 3 months, with either the INCAT score improves by \\\u003C 2 points compared to the baseline, or the treatment discontinuation due to adverse reactions:\n\n   1. Intravenous immunoglobulin (IVIG): ≥ 2 g\u002Fkg per course, with at least 2 courses completed;\n   2. Oral prednisone: ≥ 0.5 mg\u002Fkg per day for 3 months;\n   3. Plasma exchange: ≥ 5 sessions per course, with at least 1 course completed;\n   4. FcRn blockers (e.g., Efgartigimod): ≥ 1 full treatment cycle completed.\n5. If receiving glucocorticoid treatment, the subject must have received stable dosage and regimen for at least 2 weeks before screening; if receiving immunosuppressants or small-molecule targeted therapeutic drugs, the subject must have received stable dosage for at least 2 weeks before screening.\n\nInclusion Criteria for AE Patients:\n\n1\\. According to the 2016 International Diagnostic Criteria for Autoimmune Encephalitis (AE), the patient is clinically diagnosed with autoimmune encephalitis and meets all the following requirements: Positive result in the detection of at least one relevant autoantibody; Poor symptom control or intolerance to previous standardized treatment with glucocorticoids and at least one immunosuppressant\u002Fimmunomodulator (including CD20 monoclonal antibody); Occurrence of an autoimmune encephalitis attack within 3 months before signing the informed consent form; At the time of screening, the disability status meets either a modified Rankin Scale (mRS) score of ≥ 2 or a Clinical Assessment Scale in Autoimmune Encephalitis (CASE) score of ≥ 4.\n\nExclusion Criteria:\n\n1. Primary diagnosis of an autoimmune disease different from the study disease, which the investigator believes may confound the efficacy evaluation of the study disease.\n2. Comorbidity with other clinically significant central nervous system (CNS) diseases or pathological changes prior to screening, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, convulsions\u002Fseizures, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.\n3. History of allogeneic bone marrow or stem cell transplantation, or solid organ transplantation (e.g., kidney, lung, heart, liver), or planned future transplantation of such organs\u002Fcells.\n4. For MG patients: Uncontrolled myasthenic crisis within 2 weeks prior to screening.\n5. For CIDP patients: Pure sensory CIDP.\n6. Presence of clinically significant cardiovascular dysfunction within 12 months prior to screening, including but not limited to: New York Heart Association (NYHA) Class III or IV heart failure, myocardial infarction, unstable angina pectoris, uncontrolled or symptomatic atrial arrhythmia, or any ventricular arrhythmia.\n7. Presence of significant pulmonary or cardiac manifestations (e.g., pericarditis, pleural effusion) at screening, which the investigator assesses as making the patient unsuitable for participation in this study.\n8. Patients with severe asthma or chronic obstructive pulmonary disease (COPD); patients with mild or moderate asthma or COPD receiving stable treatment are eligible for enrollment.\n9. History of malignancy within 5 years prior to signing the ICF, except for fully treated or surgically resected non-melanoma skin cancer or carcinoma in situ (e.g., cervical cancer, bladder cancer, breast cancer) with no residual disease.\n10. Pregnant or lactating females.\n11. History of recurrent infections requiring hospitalization and intravenous antibiotics (e.g., 3 or more infections of the same type within the past year).\n12. Active infection requiring systemic treatment (e.g., infectious pneumonia, tuberculosis) within 2 weeks prior to lymphodepletion.\n13. Positive for hepatitis B surface antigen (HBsAg); or positive for hepatitis B core antibody (HBcAb) with positive hepatitis B virus (HBV) DNA detection in peripheral blood; positive for hepatitis C virus (HCV) antibody with positive HCV RNA in peripheral blood; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis antibody.\n14. Vaccination with live-attenuated vaccines within 4 weeks prior to lymphodepletion, or planned vaccination with live-attenuated vaccines during the study.\n15. Receipt of high-dose corticosteroids (prednisone ≥ 60 mg\u002Fday or equivalent dose) within 4 weeks prior to lymphodepletion, or inability to taper prednisone to ≤ 20 mg\u002Fday gradually within 3 days prior to lymphodepletion.\n16. Inability to taper or discontinue background treatment gradually prior to lymphodepletion chemotherapy, as described in Table 3.\n17. Receipt of plasma exchange, immunoadsorption, or intravenous immunoglobulin (IVIG) treatment within 4 weeks prior to screening.\n18. A history of allergy or intolerance to calcineurin inhibitors used previously.\n19. Receipt of renal replacement therapy within 3 months prior to screening, or expected need for renal replacement therapy during the study.\n20. History of drug or alcohol abuse within 1 year prior to screening.\n21. History or evidence of suicidal ideation within 6 months prior to screening, or any suicidal behavior within the previous 12 months, with the investigator determining a significant suicide risk.\n22. Use of other investigational drugs within 4 weeks or 5 half-lives (whichever is longer) prior to screening.\n23. A history of hypersensitivity or life-threatening reactions to any component or formulation of the study drug or study treatment (including lymphodepletion chemotherapy). For detailed information on the components of the study drug, please refer to the Investigator's Brochure (IB).\n24. Any other condition deemed by the investigator to potentially affect study participation, pose a safety risk to the patient, or potentially confound the interpretation of study results.",{"count":163,"type":21},36,[165],"EARLY_PHASE1","This single-arm, open-label investigator-initiated trial (IIT) evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-05 in patients with autoimmune neurological diseases, including Multiple Sclerosis (MS), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Autoimmune Encephalitis (AE), and other B-cell-mediated neuroautoimmune disorders.\n\nIn this study, the dose of CAR-T cells administered is 10×10⁶ CAR⁺T cells per kilogram of body weight. Investigators may decide whether to add other dose groups based on the subjects' safety data, pharmacokinetic (PK) data, pharmacodynamic (PD) data, and preliminary efficacy data.\n\nFor each indication, 6 to 9 subjects will be enrolled, with a total of 24 to 36 subjects planned for enrollment in the entire study.",[168,25,143,142],"Relapsing or Refractory Multiple Sclerosis (MS)",{"date":120,"type":33},{"date":171,"type":33},"2025-12-12",{"date":173,"type":21},"2028-11-01",{"name":154,"class":40},{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":184,"conditions":185,"keywords":188,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":73},"100636887","thymic-disease-autoimmunity-and-neuromuscular-junction-integrity-in-myasthenia-gravis-100636887","NCT07571525","Thymic Disease, Autoimmunity, and Neuromuscular Junction Integrity in Myasthenia Gravis","Thymic Disease, Autoimmunity, and Neuromuscular Junction Integrity in Myasthenia Gravis: An Observational Prospective Translational Cohort Study","TAILOR-MG","Inclusion Criteria:\n\n* Age ≥18 years at the time of informed consent\n* Ability to provide written informed consent and comply with study procedures\n* Availability of a serum sample for testing MG-related antibodies\n* Availability of chest imaging (CT and\u002For MRI) to classify thymic status\n\nParticipants must also meet the criteria for at least one of the following study groups:\n\nCohort 1: Thymoma with MG-related antibodies\n\n* Histologically or radiologically confirmed thymoma\n* Presence of at least one pathogenic MG-related antibody (AChR)\n* Presence or absence of clinically manifest myasthenia gravis\n\nCohort 2: Other thymic abnormalities with MG-related antibodies\n\n* Imaging or histological evidence of non-thymomatous thymic pathology (e.g., thymic hyperplasia)\n* Presence of at least one pathogenic MG-related antibody (AChR)\n* Presence or absence of clinically manifest myasthenia gravis\n\nCohort 3: Thymoma without MG-related antibodies\n\n* Histologically or radiologically confirmed thymoma\n* Negative for pathogenic MG-related antibodies (AChR)\n* No clinical diagnosis or symptoms suggestive of myasthenia gravis\n\nCohort 4: Myasthenia gravis without thymic abnormalities\n\n* Established clinical diagnosis of myasthenia gravis with consistent clinical features, supported by at least one of the following:\n\n  1. Seropositivity for MG-related antibodies (AChR, MuSK, or LRP4), or\n  2. Abnormal neuromuscular transmission demonstrated by SFEMG or RNS, or\n  3. Improvement of MG signs with treatment such as oral acetylcholinesterase inhibitors, plasma exchange, IVIg, or corticosteroids\n* Absence of thymic abnormalities on CT or MRI\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Other neuromuscular diseases that could interfere with interpretation of clinical or neurophysiological findings\n* Severe uncontrolled systemic illness that, in the investigator's judgment, may limit participation or confound study outcomes\n* Any medical or psychiatric condition, or history of substance abuse, that may compromise adherence to study procedures\n* Pregnancy or breastfeeding",{"count":83,"type":21},"The goal of this observational study is to investigate the clinical, immunological, and neuromuscular features associated with the development and progression of myasthenia gravis (MG) in adult patients with thymic abnormalities and\u002For MG-related antibodies, including individuals with or without clinically manifest disease.\n\nThe main questions it aims to answer are:\n\n* Whether integrated clinical, serological, and histopathological profiles are associated with the presence of MG and can predict disease onset or progression\n* Wheter systemic immune markers are associated with disease activity, progression, and neuromuscular junction alterations\n\nParticipants will:\n\n* Undergo clinical, neurological, and neurophysiological assessments at baseline and during follow-up\n* Provide blood samples for serological and immunological analyses\n* Provide thymic tissue and residual intercostal muscle samples (when undergoing clinically indicated thymectomy) for research analyses\n* Attend follow-up visits at 6, 12, and 18 months\n* Record daily symptoms using an electronic patient-reported outcome tool (for participants with MG)",[25,186,187],"Myasthenia Gravis Associated With Thymoma","Thymoma",[189,190],"myasthenia gravis","thymoma","2026-04-30",{"date":193,"type":33},"2026-05-06",{"date":195,"type":21},"2026-09-15",{"date":197,"type":21},"2029-12-01",{"name":199,"class":40},"IRCCS San Raffaele",{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":207,"enrollmentInfo":208,"targetDuration":4,"studyType":52,"phases":210,"briefSummary":211,"conditions":212,"keywords":219,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":73},"100599529","phase-1-phase-1-study-of-hbi0101-car-t-in-refractory-b-cell-autoimmune-diseases-100599529","NCT07085676","Phase 1 Study of HBI0101 CAR-T in Refractory B-Cell Autoimmune Diseases","A Phase 1 Dose Escalation and Safety Study of HBI0101 CART in B-cell Mediated Refractory Autoimmune Diseases","Inclusion Criteria:\n\n1. Age: 18\\~80 years old; for patients aged ≥ 75 years, geriatric assessment and endorsement are required;\n2. Diagnosis of B-cell mediated ARDs listed below:\n\n   SLE patients: individuals diagnosed with SLE according to American College of Rheumatology (ACR) and\u002For Systemic lupus international collaborating clinics (SLICC) classification criteria, who have severe and progressive disease course reflected by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score of 8 or more. Eligible patients must have failed to at least one of the conventional DMARDs (azathioprine, methotrexate, mycophenolate mofetil or cyclophosphamide), one of the calcineurin inhibitors (tacrolimus or cyclosporin) and one of the biologic agents (belimumab, rituximab or aniflorumab), each administered for a minimum of 3 months, or have a contraindication to, or have experienced toxicity from, any therapy within these categories. The failure is defined as:\n   * lack of response per SLEDAI-2k (\\\u003C4 points reduction from baseline) or no improvement in BILAG domains, or\n   * disease flare per SLEDAI-2k (≥4 points increase from baseline) or new BILAG A or ≥2 new BILAG B organ scores, or intolerance or discontinuation due to adverse effects.\n\n   SSc patients: Patients who were diagnosed with diffuse or limited cutaneous SSc according to the College of Rheumatology\u002FEuropean Alliance of Associations for Rheumatology (ACR-EULAR) classification criteria, with severe or rapidly progressive disease Eligible patients must meet any of the following criteria:\n   * Progression of skin thickening ≥ 12 over the past 6 months or Modified Rodnan skin score (mRSS) ≥15\n   * Any Medsger Disease Severity Score grade 3-4 in one major organ or grade ≥2 in two organs\n   * Progressive interstitial lung disease evidenced by HRCT or FVC \\\u003C80% or DLCO \\\u003C80%, or evidence of pulmonary function decline, defined as an absolute FVC decline of ≥ 10% , or FVC decline of 5% -9% combined with DLCO 15%.\n   * Other internal organ involvement.\n\n   Eligible patients must have failed to at least two state-of-the-art immunosuppressive therapies including MTX, MMF, cyclophosphamide, azathioprine, nintedanib, tocilizumab or rituximab; each therapy must have been administered for a minimum of 3 months, unless discontinued due to a contraindication or toxicity. The failure is defined as:\n   * lack of response in skin per mRSS (≤20% relative and ≤5 point absolute reduction from baseline) or no clinically meaningful improvement in FVC, DLCO, or other organ involved assessed by Medsger DSS, or\n   * disease flare in skin per mRSS (increase in mRSS ≥20% and ≥5 points from baseline) or decline in FVC ≥10% predicted or in DLCO ≥15% predicted from baseline, other major SSc complication, or\n   * intolerance or discontinuation due to adverse effects\n\n   IIM, including dermatomyositis, anti-synthetase syndrome, immune mediated necrotizing myopathy, and polymyositis: patients must be diagnosed with IIM according to the 2017 ACR\u002FEULAR Classification Criteria for idiopathic inflammatory myopathies.\n\n   Eligible patients must have active disease, defined by at least one of the following:\n   * CPK ≥4xULN\n   * Loss of muscle strength in the weakest muscle group for less than 80% per MMT8\n   * Evidence on MRI of active myositis within last 6 months\n   * Evidence on EMG of active myositis within last 6 months\n   * Muscle biopsy evidence of active myositis within last 6 months\n\n   Only patients with refractory disease will be recruited, defined as previous failure to (1) at least two of five non-glucocorticoids immunosuppressive therapies and (2) either rituximab or IVIG, each administered for a minimum of 3 months, or have a contraindication to, or have experienced toxicity from, any therapy within these categories. The five non-glucocorticoids therapies considered are azathioprine, MTX, MMF, IVIG, and rituximab The failure is defined as:\n   * lack of response in muscle strength per MMT-8 or CPK (\\\u003C20% relative improvement) or per MRI or\n   * disease flare in muscle strength per MMT-8 (≥30% decline) or CPK (≥30% rise) or objective worsening of other organ involvement per Myositis Disease Activity Assessment Tool or\n   * intolerance or discontinuation due to adverse effects\n\n   RA patients: Seropositive RA patients (positive for anti-cyclic citrullinated peptide and rheumatoid factor), diagnosed according to the 2010 ACR\u002FEULAR classification criteria.\n\n   Eligible patients must exhibit high disease activity (DAS28CRP ≥5.1), and be resistant to at least four conventional synthetic and biologic disease-modifying antirheumatic drugs (DMARD) groups.\n\n   Each patient must have previously received at least one medication from each of the mentioned groups, including\n   * JAK-STAT inhibitors\n   * Anti-TNF agents\n   * Anti-IL6 drugs\n   * Anti-CTLA4-Ig treatments, each administered for a minimum of 3 months, or have a contraindication to, or have experienced toxicity from, any therapy within these categories\n\n   Drug resistance is defined as:\n   * Inadequate clinical response measured by composite score DAS28CRP (\\> 3.6) or failure to reach ACR20 or\n   * Disease progression measured by DAS28CRP (≥20% increase) or radiographic progression or\n   * Intolerance or discontinuation due to adverse effects\n\n   NMOSD: Patients must be diagnosis of AQP4-IgG-positive NMOSD based on the 2015 International Panel for NMOSD Diagnosis (IPND) criteria (Wingerchuk et al., 2015).\n\n   Eligible patients must have experienced at least two relapses in the past 24 months, with at least one occurring in the preceding 12 months before screening Each patients must have previously received with inadequate disease control (one or more clinical attacks, with new MRI activity, despite adequate treatment dosing) at least one immunosuppressant for at least 6 months (azathioprine or mycophenolate mofetil) and\u002For Rituximab for at least 3 months and\u002For a targeted therapy (eculizumab, inebilizumab, or satralizumab) or must have a contraindication to such treatment.\n\n   MS patients: must have confirmed history of diagnosis of primary progressive or secondary progressive MS .\n\n   Eligible patients must have: Expanded Disability Status Scale (EDSS) score between 3.0 and 8.5 and evidence of disease activity, defined by either clinical progression and\u002For radiological finding on MRI, such as new, enhancing or enlarging lesions in the last 12 months.\n\n   Eligible patient must have previously received at least one high efficacy drug and have been offered standard treatments and have experienced disease progression or lack of efficacy despite at least six months of treatment. These will include clinical activity (new relapse\\[s\\]), radiological activity (new or enlarging T2 lesions and\u002For gadolinium-enhancing lesions on MRI), or confirmed disability progression (an increase in least 1 point on the EDSS sustained for ≥6 months).\n\n   Eligible patient must have history of treatment with anti-CD20 mAb with continuing evidence of worsening physical disability over a period of ≥6 months, with documented clinical disability progression within the year prior to inclusion, irrespective to concurrent MRI activity.\n\n   MG patients must meet all the following criteria:\n\n   \\- Confirmed diagnosis of generalized MG, supported by positive autoantibodies (anti-AChR, anti-MuSK).\n\n   Disease Severity:\n   * Myasthenia Gravis Activities of Daily Living (MG-ADL) score of ≥6, with ocular symptoms constituting less than 50% of the total score.\n   * Myasthenia Gravis Foundation of America (MGFA) clinical classification of II to IV.\n\n   Eligible patients must have Refractory Status and meet at least one of the following criteria:\n   * No improvement or worsening myasthenic symptoms, with failure to achieve minimal manifestation status or meaningful improvement in MGFA class or MG-ADL score, or recurrent myasthenic exacerbations despite adequate immunosuppressive or immunomodulatory therapy for at least 6 months for all therapies and 3 months for B cell depletion therapy\n   * Improvement in Post-Intervention Status (PIS), but with an MG-ADL score ≥6 persisting for at least 4 months.\n   * Remission or improvement in PIS, but with ≥1 episode of disease exacerbation (MG-ADL ≥6) per year during tapering of immunotherapy medications.\n   * After experiencing a myasthenic crisis, patients who undergo multiple immunotherapies (e.g., intravenous immunoglobulin, plasma exchange, high-dose intravenous methylprednisolone), thymectomy, and active infection control but still cannot be weaned off the ventilator due to MG-induced respiratory muscle weakness for more than 14 days.\n\n   Each patient must receive stable doses of medication prior to enrollment.\n\n   Refractory APLA patients: must have confirmed history of APLA, based on Sydney 2006 or ACR\u002FEULAR 2023 criteria\n\n   \\- Eligible patients must have medium to high-titer antiphospholipid antibodies, documented repeatedly (≥2 tests spanning 12 weeks) Eligible patients must have refractory disease: persistent or recurrent arterial thrombosis, venous thrombosis or diffuse alveolar hemorrhage despite conventional therapy with stable treatment with vitamin K antagonist anticoagulation (maintained at therapeutic stable dose keeping INR consistently within target range) and immunosuppression treatment including glucocorticoid, rituximab and Plaquenil\n3. AST\u002FALT below 5 times the upper limit of normal, blood bilirubin below 3 times the upper limit of normal ;\n4. Cardiopulmonary function is basically normal, echocardiography indicates that the ejection fraction is \\>45%, normal to mild pulmonary hypertension, and the oxygen saturation is above 93% in the resting state without oxygen;\n5. No obvious active infection;\n6. There are no contraindications for blood collection;\n7. Women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months, must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study;\n8. Voluntary participation and informed consent signed by the patient or his\u002Fher legal\u002Fauthorized representative.\n9. Ability and willingness to adhere to the study visit schedule and all protocol requirements\n\nExclusion Criteria\n\n1. CNS disease- History of CNS or spinal cord tumor, metabolic or infectious cause of myelopathy, genetically inherited progressive CNS disorder, sarcoidosis, non-autoimmune progressive neurologic condition or PML\n2. Abnormal liver function: aspartate transaminase (AST) or alanine transaminase (ALT) or glutamyl transpeptidase (GGT) or alkaline phosphatase (ALP) detection value is greater than 5 times the upper limit of normal (ULN); or total bilirubin test value greater than 3 times the upper limit of normal (ULN); Exceptional: liver function disturbance due to myositis.\n3. Cardiovascular disease: Unstable angina or myocardial infarction or coronary artery bypass graft (CABG) within 6 months prior to leukapheresis\u002F moderate- severe pulmonary hypertension\u002F severe arrhythmia (ventricular tachycardia, ventricular fibrillation, high grade ventricular block) in the past 6 months; New York heart function class (NYHA) class III- Level IV or LVEF\\\u003C45%.\n4. Lung disease: patients with chronic lung disease with any of the following: \\* Oxygen saturation (SpO2) \\\u003C 90% on room air \\* FVC≤45% of predicted or DLCO≤40% of predicted at screening. \\* Evidence of pulmonary hypertension as defined as estimated RVSP\\> 50 mmHg.\n5. Muscle disease: evidence of any of the following: \\* Severe proximal muscle atrophy of upper or lower extremity on MRI or clinical examination. \\*Finding of muscular inflammation or myopathy other than the indication, such as inclusion body myositis (IBM), or cancer-associated myositis (myositis diagnosed within 2 years of cancer).\n6. Other uncontrolled diseases: acute diseases (such as acute pneumonia or other infection, pulmonary embolism, diabetic ketoacidosis, acute pancreatitis, etc.) that are clinically unstable or have not been effectively controlled and are not related to indicated autoimmune diseases which in the judgment of the investigator may confound study results or place subjects at undue risk.\n7. Biologics therapy: Received rituximab within 4 months of expected CAR T treatment: No plasma exchange or immunoglobulin treatment within 4 weeks prior to screening. MS patients: No high dose corticosteroid treatment in the 30 days prior to enrollment; see also section 9.1 for the list of restrictions.\n8. Participated in any clinical study within 3 months prior to enrollment, or participate in other clinical investigations during the study period.\n9. Previous or concurrent malignancy with the following exceptions: Adequately treated basal cell or squamous cell carcinoma, in situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to screening. A primary malignancy which has been completely resected, or treated, and is in complete remission for at least 5 years prior to screening.\n10. Transplantation: History of vital organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell\u002For bone marrow transplantation.\n11. Disease-specific criteria: MS\u002FNMO patients: No disease relapse in the 30 days prior to enrollment\n12. Known HIV positive status.\n13. Active hepatitis B or C infection.\n14. Active CMV infection\n15. Pregnant or lactating women.\n16. Inability to understand or follow the research protocol subject requirements.\n17. Have any other clinically significant disease history or current disease that, in the judgment of the research physician, may pose a risk to the safety of the subjects, or interfere with the completion of the research procedure and the evaluation of safety and efficacy","80 Years",{"count":209,"type":21},120,[54],"A Phase 1 study of HBI0101 BCMA-CART in B-Cell Mediated Autoimmune Rheumatic Diseases. The goal of the study is evaluation of safety and identification of the maximum HBI0101 CART dose that may be administered safely to patients with B-cell mediated autoimmune disease.",[213,214,119,215,216,217,141,25,218],"Systemic Sclerosis (SSc)","Idiopathic Inflammatory Myopathy (IIM)","Systemic Lupus Erythematosus (SLE)","Multiple Sclerosis (MS) Primary Progressive","Multiple Sclerosis (MS) Secondary Progressive","Antiphospholipid Antibody Syndrome",[220,215,221,222,223,224,225,226,141,25,227],"B-cell mediated autoimmune rheumatic diseases","Systemic sclerosis (SSC)","Idiopathic inflammatory myopathy (IIM)","Rheumatoid arthritis (RA)","B-cell maturation antigen (BCMA)","Autologous CAR-T","Multiple sclerosis (MS) Primary and Secondary progressive","refractory antiphospholipid antibody syndrome","2026-04-29",{"date":193,"type":33},{"date":231,"type":33},"2024-09-01",{"date":233,"type":21},"2030-11-01",{"name":235,"class":40},"Polina Stepensky",{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":243,"targetDuration":4,"studyType":52,"phases":244,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":4},"100631334","talquetamab-in-patients-with-refractory-generalized-myasthenia-gravis-100631334","NCT07499323","Talquetamab in Patients With Refractory Generalized Myasthenia Gravis","A Preliminary Case Study to Evaluate the Efficacy and Safety of Talquetamab in Patients With Refractory Generalized Myasthenia Gravis","Inclusion Criteria:\n\n* The patient must sign the informed consent form for participation in the study and agree to comply with the study procedures.\n* Age 18-70 years.\n* Must meet the clinical diagnostic criteria for MG, defined as presenting with a typical pattern of weakness (predominantly affecting proximal muscles, fatiguability, fluctuating severity, worse with prolonged effort and better after rest) and meeting any one of the following three conditions: documented history of abnormal neuromuscular transmission confirmed by single-fiber electromyography or repetitive nerve stimulation; documented history of a positive neostigmine test; or improvement in MG signs following oral administration of an acetylcholinesterase inhibitor. Additionally, the Myasthenia Gravis Foundation of America (MGFA) clinical classification must be II-IV, and the patient must be positive for anti-AChR antibodies.\n* Must meet the definition of \"refractory myasthenia gravis\" according to the Chinese Guidelines for the Diagnosis and Treatment of Myasthenia Gravis (2025 Edition): defined as having a suboptimal response to conventional immunotherapeutic drugs, intolerance to or having contraindications for adverse drug reactions, or experiencing frequent disease relapses requiring regular rescue therapy, making it difficult to achieve treatment goals.\n* Myasthenia Gravis Activities of Daily Living (MG-ADL, Appendix 1) score ≥6, with \\>50% of the score derived from non-ocular items.\n* Quantitative Myasthenia Gravis (QMG) score (Appendix 2) ≥8, with \\>50% of the score derived from non-ocular items.\n* The dosage of pyridostigmine bromide must be stable for at least 1 week prior to the treatment period.\n\nExclusion Criteria:\n\n* Patients who have had their glucocorticoid dose adjusted, or who have received immunoglobulins, plasma exchange, neonatal Fc receptor inhibitors, or complement inhibitors within ≤4 weeks.\n* Patients who have undergone thymectomy, received B-cell depletion therapy, or had their dose of non-steroidal immunosuppressants (such as azathioprine, tacrolimus, mycophenolate mofetil, cyclophosphamide, etc.) adjusted within ≤3 months.\n* Patients who have participated in any interventional clinical trial or received investigational treatment within ≤3 months, or within 5 half-lives of the received investigational drug (whichever is longer).\n* Patients with concurrent severe liver, kidney, cardiac, pulmonary, or coagulation dysfunction.\n* Patients with concurrent chronic infections such as Human Immunodeficiency Virus, Hepatitis B Virus, Hepatitis C Virus, or Mycobacterium tuberculosis.",{"count":41,"type":21},[112],"Myasthenia Gravis (MG) is a chronic autoimmune disease mediated by pathogenic antibodies. Approximately 10%-15% of patients present with refractory status, defined as having an inadequate response to existing therapies or an inability to tolerate the side effects of the medication, highlighting an urgent need for the development of more targeted innovative therapies. Talquetamab is a bispecific antibody that targets G Protein-Coupled Receptor Class C Group 5 Member D (GPRC5D) and the Cluster of Differentiation 3 (CD3) molecule on the surface of T cells, thereby inducing T cells to precisely eliminate GPRC5D-positive cells. This study will conduct an exploratory case series to investigate the efficacy and safety of Talquetamab in refractory MG.",[25],"2026-04-03",{"date":249,"type":33},"2026-04-08",{"date":251,"type":21},"2026-03-20",{"date":253,"type":21},"2027-04-01",{"name":255,"class":40},"First Affiliated Hospital of Chongqing Medical University",{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":4},"100632337","the-effectiveness-of-an-etp-programme-in-myasthenia-gravis-a-proof-of-concept-study-100632337","NCT07512375","The Effectiveness of an ETP Programme in Myasthenia Gravis: a Proof-of-concept Study.","Efficacité d'un Programme d'ETP Dans la myasthénie : étude de Preuve de Principe (MY-EDUC).","MY-EDUC","Inclusion Criteria:\n\n* Participant is aged 18 years or over (legal age of majority under French law).\n* Participant has freely provided their non-opposition to participate in the study.\n* Participant has a confirmed diagnosis of Myasthenia Gravis.\n* Participant has sufficient proficiency in both spoken and written French to complete assessments and questionnaires, attend the programme sessions, and carry out home-based exercises.\n\nExclusion Criteria:\n\n* Participant presenting with one or more severe and established psychiatric disorders (e.g. severe depression, psychosis) that could interfere with the study's conduct, particularly the assessment of the primary and secondary endpoints.\n* Participant presenting with another chronic condition that induces fatigue. Protected persons (as defined by Articles L1121-5 to L1121-8 of the French Public Health Code \\[CSP\\]).",{"count":265,"type":21},62,"CONTEXTE. Myasthenia gravis is a rare neuromuscular junction disorder affecting one in five thousand people (ORPHA 589). It is a chronic condition that progresses in episodes. Its severity varies, ranging from the invisible disability of fatigue to respiratory distress requiring intensive care. Currently, 270 patients with myasthenia gravis are being treated at Grenoble University Hospital in the Reference Centre for Rare Neuromuscular Diseases.\n\nThe impact of this disease on quality of life is significant, and medication alone is not sufficient. However, to date, there are virtually no psychosocial interventions for patients with myasthenia gravis and no studies evaluating their effectiveness.\n\nIn this context, the Cognitive Behavioural Stress Management (CBSM) programme is one of the stress management programmes applied to chronic health conditions whose effectiveness has already been demonstrated, particularly in terms of treatment adherence, quality of life, patients' coping strategies in the face of a chronic illness, and the outcomes of medical treatments (Antoni, 2003; Antoni et al., 2002, 2006).\n\nPRIMARY OBJECTIVE. Evaluation of the adaptation of an existing patient education programme, 'Living Better with Myasthenia', following the inclusion of an eight-session CBSM-based stress management module for adult patients living with myasthenia.\n\nMETHODOLOGY (brief). Adaptation of the CBSM programme to the specific characteristics of myasthenia gravis:\n\n1. Focus groups: exploration of beliefs associated with stress in myasthenia gravis.\n2. DELPHI group: validation of the adaptation of the ETP programme 'Living better with myasthenia gravis' implemented at CHUGA following the inclusion of a stress management module (CBSM).\n\nAssessment of the feasibility of the MY-EDUC programme among groups of patients with myasthenia gravis.\n\nPRIMARY OUTCOME MEASURE. Comparison of levels of anxiety, depression (HADS), perceived stress (PSS) and quality of life (SF-36) as self-reported by patients enrolled in the programme before and after the MY-EDUC intervention.\n\nRESEARCH PROCEDURE. 1.1. FOCUS GROUPS. Expert patients and partner patients. They will be contacted via the list maintained by the rare disease healthcare network.\n\n'General public' patients. A call for participants will be displayed in the CHUGA waiting room and circulated by partner organisations to their members.\n\nThe study will be presented to expert and partner patients, as well as to \"walk-in\" patients in the focus groups, using the contact details on the \"rare disease healthcare network\" lists and via posters. An information leaflet outlining the study and its objectives will be provided to them.\n\n1.2. FEASIBILITY AND ACCEPTABILITY STUDY OF THE MY-EDUC PROGRAMME. 1.2.1. Participant inclusion. Patient eligibility. The assessment of patient eligibility will be carried out by a specialist doctor from the CHUGA Rare Disease Centre of Excellence during a routine consultation with the patient (routine care).\n\nParticipant inclusion. Once patient eligibility has been verified, the investigator from the CHUGA Rare Disease Centre, or a person to whom they have delegated this task, will contact the patient to invite them to participate in the MY-EDUC study. They will provide a verbal explanation of the study and hand over an information sheet during a follow-up consultation with the patient as part of routine care. If the patient volunteers to participate, they will give their consent to participate.\n\nThe patient's consent will be recorded in the medical record. 1.2.2. Baseline assessment (T0). In the week leading up to the first session of the MY-EDUC programme, participants will complete the baseline assessment online (using the LimeSurvey platform - secure servers at the University of Grenoble Alpes) with questionnaires presented in a randomised order.\n\n1.2.3. Assessment during the intervention (T1). Based on repeated ecological measurements (Shiffman et al., 2008) via the study participants' mobile phones (two measurement points, before and after each session, randomly scheduled at least 36 hours apart, i.e. 16 measurements) using the free PielsSurvey software.\n\n1.2.4. Final assessments (T2 and T3). Within one week of the final session of the MY-EDUC programme (T2: week 10 after T0), participants will complete a set of questionnaires electronically (using the LimeSurvey platform - secure servers at the University of Grenoble Alpes), with the validated questionnaires presented in a randomised order.",[25],"2026-03-30",{"date":270,"type":33},"2026-04-06",{"date":272,"type":21},"2026-04",{"date":274,"type":21},"2027-06",{"name":276,"class":40},"University Hospital, Grenoble",{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":284,"targetDuration":4,"studyType":52,"phases":285,"briefSummary":286,"conditions":287,"keywords":290,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":73},"100629092","clinical-study-of-evm18001-in-the-treatment-of-refractory-autoimmune-diseases-100629092","NCT07470151","Clinical Study of EVM18001 in the Treatment of Refractory Autoimmune Diseases","Exploratory Clinical Study of EVM18001 Injection in the Treatment of Active Refractory Systemic Lupus Erythematosus, Myasthenia Gravis and Scleroderma","Inclusion Criteria:\n\n1. Voluntarily sign the Informed Consent Form (ICF), which must be signed by the participant or their legal guardian.\n2. At the time of signing the ICF, the age must be between 18 and 70 years (inclusive), regardless of gender.\n3. At screening, peripheral blood B cells must be CD19 positive, and T cells must express CD7.\n4. Confirmed autoimmune diseases based on recognized diagnostic criteria, including:\n\n   * SLE: Diagnosed with SLE according to the 2012 Systemic Lupus International Collaborating Clinics (SLICC) or 2019 European League Against Rheumatism (EULAR)\u002FACR criteria;\n   * MG: Diagnosed with MG according to the Myasthenia Gravis Foundation of America (MGFA) clinical classification;\n   * SSc: Diagnosed with SSc according to the 2013 ACR\u002FEULAR classification criteria.\n5. History of autoimmune disease for at least 6 months before screening and meets any of the following criteria. Definitions of active refractory SLE, active refractory SSc, and active refractory MG are as follows:\n\n   * Definition of active refractory SLE: SLEDAI-2000 score ≥6; and disease activity or relapse persists after at least 3 months of standard therapy (glucocorticoids combined with at least 2 immunosuppressants, or at least 1 imunosuppressant and 1 targeted therapy).\n   * Definition of active refractory SSc: Patients meeting the 2013 ACR\u002FEULAR classification criteria for SSc who still show disease activity or progression after at least 6 months of standard therapy (including steroids, immunosuppressants, vasodilators, or antifibrotic agents). Specific criteria include but are not limited to: mRSS increase ≥5 points or ≥25% from baseline; absolute value of predicted FVC% decrease ≥5%; DLCO% corrected for hemoglobin absolute value decrease ≥10%; new or worsening digital ulcers after ≥3 months of vasodilator therapy; persistent or recurrent organ involvement requiring intensified treatment.\n   * Definition of active refractory MG: Refers to generalized MG patients meeting MGFA diagnostic criteria with ongoing disease activity (MGFA II-IV, QMG ≥12, or MG-ADL ≥6), and includes at least one of the following: poor control after at least 12 months of standard therapy (including at least 2 immunosuppressants); need for ≥2 intravenous immunoglobulin (IVIG) or plasma exchange treatments in the past 12 months to control symptoms; relapse with prednisone ≥20 mg\u002Fday or reduction to \\\u003C10 mg\u002Fday; persistent or recurrent disease activity.\n6. Patients must meet the following conditions for concomitant medication:\n\n   1. Corticosteroids must have been used for more than 6 weeks prior to screening and at a stable dose of ≤ 10 mg\u002Fday prednisone or equivalent for at least 14 days prior to administration of EVM18001. Concurrent treatment with topical or inhaled corticosteroids (or other immunomodulators) is allowed;\n   2. Continued use during treatment is allowed if antimalarial drugs (eg, hydroxychloroquine, chloroquine, etc.) are started ≥ 12 weeks prior to screening and maintained at a stable dose for ≥ 8 weeks (maximum dose limit: hydroxychloroquine, 400 mg\u002Fday; chloroquine, 500 mg\u002Fday).\n7. Examination at screening meet any of the following criteria:\n\n   * SLE: positive for blood ANA, and\u002For positive for anti-dsDNA, anti-Smith antibodies;\n   * MG: Positive serology for anti-AChR antibodies or anti-musclespecific tyrosine kinase receptor (MuSK) antibodies.\n8. Life expectancy greater than 6 months.\n9. Bone marrow reserve and organ function are normal:\n\n   * Bone marrow function: defined as absolute neutrophil count (ANC) ≥ 1.0×109\u002FL, absolute lymphocyte count (ALC) ≥0.5×109\u002FL, hemoglobin (Hb) ≥80g\u002FL, platelet count (PLT) ≥50×109\u002FL. Blood transfusions and growth factors must not be used to meet these requirements within 7 days prior to screening for eligibility.\n   * Coagulation function: defined as international normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤ 1.5× upper limit of normal (ULN).\n   * Cardiac function: defined as left ventricular ejection fraction (LVEF) ≥ 45% as assessed by echocardiography (ECHO).\n   * Pulmonary function: defined as Common Terminology Criteria ≤for Adverse Events (CTCAE) Grade 1 dyspnea and oxygen saturation (SpO2) ≥ 92% (pulse oximetry) on room air.\n   * Hepatic function: defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× ULN, total bilirubin \\\u003C 2.0mg\u002FdL (total bilirubin of Gilbert syndrome trial participants \\\u003C3.0mg\u002FdL).\n   * Renal function: defined as calculated creatinine clearance (Cockcroft-Gault) ≥ 50 mL\u002Fmin without hydration assistance.\n10. Female trial participants of childbearing potential:\n\n    * Negative serum β human chorionic gonadotropin (β-hCG) test at screening;\n    * Agree to use a highly effective method of contraception for the duration of study participation and for 12 months after EVM18001 last infusion.\n11. Male trial participant whose partner is of childbearing potential who agrees to use a highly effective method of contraception during the study and 12 months after the last infusion of the EVM18001.\n\nExclusion Criteria:\n\n1. Concurrent autoimmune diseases requiring systemic treatment.\n2. The autoimmune disease meets the following criteria:\n\n   * SLE: patients with renal crisis;\n   * MG: MGFA clinical classification type V or experiencing myasthenic crisis;\n   * SSc: involving lungs and exist severe ILD and severe PAH, or patients with scleroderma renal crisis.\n3. Any of the following conditions exist:\n\n   * Positive for Hepatitis B surface antigen (HBsAg)\u002Fcore antibody (HBcAb)\u002Fe-antibody (HBeAb)\u002Fe antigen (HBeAg);\n   * Positive for Hepatitis C virus (HCV) antibody;\n   * Positive for human immunodeficiency virus (HIV) antibody;\n   * Positive CMV DNA or above the upper limit of detection;\n   * Positive for syphilis antigen or antibody.\n4. Other uncontrolled active infections exist at screening.\n5. Creatinine clearance \\\u003C50 mL\u002Fmin.\n6. Estimated glomerular filtration rate \\\u003C45 mL\u002Fmin\u002F1.73m² (calculated using the MDRD creatinine equation from the Chronic Kidney Disease Epidemiology Collaboration; or serum creatinine \\>2.0 mg\u002FdL.\n7. History of major organ transplantation (such as heart, lung, liver, kidney) or bone marrow\u002Fhematopoietic stem cell transplantation.\n8. History within 6 months before screening of any of the following cardiovascular diseases: NYHA class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia, or other clinically significant heart disease.\n9. History of ≥grade 2 bleeding within 4 weeks before screening, or requiring long-term continuous anticoagulant therapy (such as warfarin, low molecular weight heparin, or factor Xa inhibitors, etc.).\n10. History within the past 24 weeks\u002F6 months of severe active central nervous system disease or pathology, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, convulsions\u002Fseizures, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychiatric disorders. Stable patients will be assessed by the investigator for eligibility.\n11. Diagnosed with malignant tumors within the past 5 years. The following are excluded: non-melanoma skin cancer treated with radical therapy, localized prostate cancer, biopsy-confirmed cervical carcinoma in situ or squamous intraepithelial lesions detected by cervical smear, and completely resected breast carcinoma in situ.\n12. History of live vaccine administration within the past 4 weeks.\n13. Have received any of the following treatments:\n\n    * Preventive therapy with short-acting oral antiretroviral drugs within 7 days before first administration, or preventive therapy with longacting antiretroviral drugs within 2 years before first administration;\n    * Plasma exchange, plasmapheresis, or hemodialysis within 14 days before screening;\n    * Any other clinical study drug within 4 weeks before screening. However, if the study treatment was ineffective or the disease progressed, and at least 3 half-lives had passed before screening, enrollment is allowed;\n    * History of bone marrow transplantation, gene therapy, adoptive cell therapy, or any type of CAR-T cell therapy;\n    * Previously received any mRNA-LNP product or other LNP-based drugs.\n14. Unable to complete washout of previous treatment drugs as required within 4 weeks before first administration, or unable to maintain stable doses of concomitant medications for autoimmune diseases.\n15. Pregnant or breastfeeding women.\n16. Allergic to supportive medications required for managing CAR-T cell therapy toxicities (e.g., tocilizumab).\n17. Other situations where the investigator judges that the trial participant has poor compliance or is unwilling or unable to adhere to the study protocol.",{"count":5,"type":21},[112],"A FIH, single arm, open-label, Investigator Initiated Trial (IIT) study to evaluate the safety and tolerability of EVM18001 in the treatment of active refractory autoimmune diseases (SLE, MG, and SSc), and determine the recommended dose for subsequent treatment. At the same time, the PK\u002FPD characteristics of EVM18001 will be evaluated, preliminary efficacy will be observed, and related biomarkers and immunogenicity will be explored.",[288,289,25],"System Lupus Erythematosus(SLE)","Scleroderma",[291,292,289,293,294,295],"Active Refractory Systemic Lupus Erythematosus","Myasthenia Gravis","EVM18001","CAR-T","Refractory Autoimmune Diseases","2026-03-10",{"date":298,"type":33},"2026-03-13",{"date":300,"type":21},"2026-03-12",{"date":302,"type":21},"2027-12",{"name":304,"class":40},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":306,"slug":307,"hasResults":11,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":311,"eligibilityCriteria":312,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":108,"enrollmentInfo":313,"targetDuration":4,"studyType":52,"phases":315,"briefSummary":316,"conditions":317,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":324,"locationsCount":4},"100621606","phase-1-ripertamab-for-the-treatment-of-myasthenia-gravis-100621606","NCT07372807","Ripertamab for the Treatment of Myasthenia Gravis","Safety and Efficacy of Ripertamab in Generalized Myasthenia Gravis","RIPERT-MG","Inclusion Criteria:\n\n(1) Aged ≥ 18 years and ≤ 75 years at screening.(2) Confirmed diagnosis of generalized myasthenia gravis (gMG).(3) Positive for anti-acetylcholine receptor (anti-AChR), anti-muscle-specific kinase (anti-MuSK), and\u002For anti-low-density lipoprotein receptor-related protein 4 (anti-LRP4) antibodies.(4) A score of ≥ 6 on the Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale, with the ocular subscore accounting for less than 50% of the total score.(5) Classified as Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Types Ⅱ, Ⅲ, or Ⅳ.(6) Voluntary signing of the informed consent form by the patient and\u002For their legal representative.\n\nExclusion Criteria:\n\n(1) Any condition that the investigator deems likely to interfere with the evaluation of the study drug, assessment of patient safety, or interpretation of study results.(2) A history of any uncontrolled active infection or severe infection within 8 weeks prior to screening.(3) Receipt of rituximab or any B-cell depleting agent within 6 months prior to screening; note: Subjects with CD19+ or CD20+ B-cell counts above the lower limit of normal are eligible for enrollment.(4) Administration of tocilizumab, eculizumab, mitoxantrone, cyclophosphamide, or other alkylating agents within 3 months prior to the first dose.(5) Administration of immunosuppressants other than glucocorticoids within 1 month prior to the first dose, including but not limited to azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine, and methotrexate.(6) Receipt of plasma exchange (PE), moderate-volume blood transfusion, or immunomodulatory drugs (e.g., interferon β, interferon γ, or intravenous immunoglobulin \\[IVIG\\]) within 1 month prior to the first dose.(7) Performance of thymectomy within 12 months prior to baseline, or a planned thymectomy during the 12-week study period.(8) Comorbidity with other chronic active autoimmune diseases requiring treatment with glucocorticoids, biologics, or immunosuppressants (e.g., rheumatoid arthritis, scleroderma).(9) Vaccination with live or attenuated vaccines within 1 month prior to the first dose.(10) A history of previous bone marrow transplantation, hematopoietic stem cell transplantation, total lymphoid irradiation, or T-cell vaccine therapy.(11) Receipt of any investigational drug within 28 days prior to the first dose or 5 times the half-life of the investigational drug, whichever is shorter.(12) Known hypersensitivity to any component of ripertamab.(13) Pregnant or lactating females; for women of childbearing potential (WOCBP) who have not undergone sterilization: refusal to use appropriate contraceptive methods (e.g., oral contraceptives, intrauterine devices \\[IUDs\\], or barrier contraception combined with spermicides) from screening until 6 months after the end of treatment.(14) For males who have not undergone sterilization: refusal to use barrier contraception from screening until 6 months after the end of treatment, and refusal to request their partners to use other contraceptive methods (e.g., oral contraceptives, IUDs, barrier methods, or spermicides).",{"count":314,"type":21},20,[54,85],"The goal of this clinical trial is to learn if ripertamab works to treat myasthenia gravis. It will also learn about the safety of ripertamab. The main questions it aims to answer are:Will ripertamab improve the symptoms of participants?What medical problems do participants have when using ripertamab?Researchers will compare ripertamab to a placebo (a look-alike substance that contains no drug) to see if ripertamab works to treat chronic inflammatory demyelinating polyneuropathy.Participants will:A single intravenous infusion of ripertamab.Visit the clinic for checkups and tests during W1, W2, W4, W8, W12. Keep a diary of their symptoms and the number of times they undergo rescue therapy.",[25],"2026-01-19",{"date":320,"type":33},"2026-01-28",{"date":322,"type":21},"2026-02",{"date":302,"type":21},{"name":325,"class":40},"Zhongming Qiu"]