[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-inflammatory-demyelinating-polyneuropathy-cidp\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-inflammatory-demyelinating-polyneuropathy-cidp":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,46,67,85,122,160],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100633423","phase-1-safety-and-pharmacodynamics-of-qh103-cell-injection-in-the-treatment-of-patients-with-relapsedrefractory-antibody-mediated-neurological-autoimmune-diseases-100633423",false,"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.","ALL","18 Years","75 Years",{"count":5,"type":20},"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","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.",[26,27,28,29,30,31,32],"Multiple Sclerosis (MS)","Neuromyelitis Optica Spectrum Disorder (NMOSD)","Autoimmune Encephalitis (AE)","Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","Myasthenia Gravis (MG)","Anti-Myelin Oligodendrocyte Glycoprotein Immunoglobulin G Antibody-Associated Disease (MOGAD)","Idiopathic Inflammatory Myopathies (IIM)","RECRUITING","2026-05-07",{"date":36,"type":37},"2026-05-12","ACTUAL",{"date":39,"type":37},"2026-04-01",{"date":41,"type":20},"2028-12-31",{"name":43,"class":44},"Tongji Hospital","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":45},"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.","70 Years",{"count":55,"type":20},36,[57],"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.",[60,30,29,28],"Relapsing or Refractory Multiple Sclerosis (MS)",{"date":36,"type":37},{"date":63,"type":37},"2025-12-12",{"date":65,"type":20},"2028-11-01",{"name":43,"class":44},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":82,"locationsCount":4},"100422200","pre-approval-access-for-efgartigimod-ph20-sc-in-adults-with-chronic-inflammatory-demyelinating-polyneuropathy-cidp-100422200","NCT04777734","Pre-Approval Access for Efgartigimod PH20 SC in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","Pre-Approval Access for Efgartigimod PH20 SC in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","Inclusion Criteria:\n\n* Cannot be included in an ongoing clinical study and cannot be satisfactorily treated with a product that has regulatory approval\n* Is ≥18 years of age at the time of signing the informed consent form\n* Patient has a diagnosis of CIDP according to the 2021 EAN\u002FPNS CIDP guidelines\n* Patient has progressive or relapsing active disease after prior treatment with corticosteroids or immunoglobulins\n\nExclusion Criteria:\n\n* Known autoimmune disease or any medical condition that, in the opinion of the treating physician, would interfere with an accurate assessment of clinical symptoms of CIDP or that puts the patient at undue risk\n* Is currently being treated or plans to start treatment with monoclonal antibodies or treatments that contain the human Fc domain of the IgG subclass\n* Pregnant or lactating state or intention to become pregnant during the program","EXPANDED_ACCESS","The aim of the Pre-Approval Access program is to provide efgartigimod PH20 SC treatment to patients with CIDP who are ineligible to participate in a clinical study and have unmet medical need despite available treatment options. The program will continue until the patient discontinues treatment or until the reimbursement process for CIDP concludes, whichever comes first.",[29,77],"CIDP","AVAILABLE","2026-03-20",{"date":81,"type":37},"2026-03-24",{"name":83,"class":84},"argenx","INDUSTRY",{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":95,"phases":4,"briefSummary":96,"conditions":97,"keywords":102,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":45},"100628458","studying-nerve-function-and-structure-in-charcot-marie-tooth-disease-anti-mag-neuropathy-and-cidp-100628458","NCT07461896","Studying Nerve Function and Structure in Charcot-Marie-Tooth Disease, Anti-MAG Neuropathy and CIDP","Axonal Excitability and Ultrasound Patterns in Charcot-Marie-Tooth Disease and Other Demyelinating Disorders","CMT-NFS","Inclusion Criteria:\n\n1. The subject is ≥ 18 years old.\n\n   AND:\n2. A genetically confirmed diagnosis of one of the several CMT subtypes (i.e., CMT1A, CMT1B, CMTX1, CMT2I\u002FJ, CMT4B, CMT4D and CMT4J) OR\n3. A clinical diagnosis of either Chronic Inflammatory Demyelinating Polyneuropathy or anti-MAG polyneuropathy\n\nExclusion Criteria:\n\n1. Known neuropathy from another cause (e.g., diabetes, chronic renal insufficiency, medications, alcohol), including previous carpal tunnel syndrome surgery.\n2. History of exposure to chemotherapeutic agents (e.g., bortezomib, vincristine, cisplatin, taxol, vedotin\u002Fauromycin-conjugated antibodies), or other medications (e.g., disulfuram, thalidomide, voriconizole, chronic colchicine use) that can cause neuropathy, active alcohol abuse.\n3. History of cancer, other than skin cancer, within 5 years prior to enrollment.\n4. Pregnancy or nursing.\n5. Known systemic disease that predisposes to neuropathy.\n6. Other central nervous system diseases.",{"count":94,"type":20},39,"OBSERVATIONAL","The project aims to perform both conventional nerve-conduction studies and axonal-excitability assessments using the TRONDF protocol in patients with selected forms of Charcot-Marie-Tooth disease, with comparison to individuals affected by dysimmune, acquired neuropathies, specifically chronic inflammatory demyelinating polyneuropathy (CIDP) and anti-MAG-neuropathy. The study further includes the analysis of nerve fibers obtained from skin biopsy in patients with CMT, as well as ultrasound evaluation of nerves (from the wrist to the axilla) and of intrinsic hand muscles. Axonal-excitability techniques involve the delivery of two electrical stimuli to the nerve under investigation; both stimuli vary in intensity, whereas only the first, known as the conditioning stimulus, varies in duration. Changes in response amplitude are then measured as these stimulation parameters are systematically adjusted. Some preliminary studies have already suggested the effectiveness of this method in distinguishing CMT1A from certain forms of acquired demyelinating disease, including acute inflammatory demyelinating polyradiculoneuropathy (AIDP) and CIDP. Despite the promising results, only a limited number of studies have so far been conducted in humans and mice, and no comprehensive and systematic study has yet been carried out describing the changes in axonal excitability in the various CMT subtypes, either in humans or in mouse models.",[98,99,29,100,101],"Charcot-Marie-Tooth","CMT1A","Polyneuropathy Associated With Anti-MAG Antibodies (Anti-MAG Polyneuropathy)","Anti-MAG Neuropathy",[98,103,104,105,99,106,107,108,109,110,111,77,112],"Neurophysiology","Axonal excitability","Ultrasound (US)","CMT1B","CMTX1","CMT2I\u002FJ","CMT4B2","CMT4D","CMT4J","anti-MAG","2026-03-06",{"date":115,"type":37},"2026-03-10",{"date":117,"type":37},"2025-03-03",{"date":119,"type":20},"2026-05",{"name":121,"class":44},"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":129,"sex":16,"minAge":17,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":95,"phases":4,"briefSummary":133,"conditions":134,"keywords":142,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":45},"100519209","polyneuropathy-impairments-and-physical-activity---the-polyimpact-study-100519209","NCT06040567","Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study","PolyImPAct","Inclusion Criteria:\n\nInclusion Criteria patients:\n\n\\> 18 years Diagnosed with polyneuropathy (verified by nerve conduction)\n\nInclusion Criteria healthy controls:\n\n\\> 18 years Healthy\n\nExclusion Criteria:\n\nExclusion Criteria patients:\n\nNot verified polyneuropathy\n\nExclusion Criteria healthy controls:\n\nDiabetes, brain-, nerve-, muscle-, kidney-, or liver disease. Diagnosed with polyneuropathy",true,"100 Years",{"count":132,"type":20},520,"The project aims to investigate the validity, and reliability of outcome measures of muscle strength, functioning (gait, balance, and fine motor skills), physical activity, and patient-reported outcome measures of functioning (gait, balance, and fine motor skills), and daily living among patients with polyneuropathy. Further, the project aims to compare physical activity and patient-reported outcome measures of functioning (gait, balance, and fine motor skills), and daily living among patients with polyneuropathy with physical activity and patient-reported outcome measures of functioning (gait, balance, and fine motor skills) and daily living in healthy adults.",[29,135,136,137,98,138,139,140,141],"Vasculitic Neuropathy","POEMS Syndrome","Multifocal Motor Neuropathy","hATTR Amyloidosis","Diabetic Polyneuropathy","Idiopathic Neuropathy","Polyneuropathies",[143,144,145,146,147,148,149,150],"Polyneuropathy","Clinical outcome measures","Patient reported outcome measures (PROMs)","Physical activity","Accelerometer","Validity","Reliability","Responsiveness","2025-04-03",{"date":153,"type":37},"2025-04-06",{"date":155,"type":37},"2023-09-23",{"date":157,"type":20},"2026-12-31",{"name":159,"class":44},"Rigshospitalet, Denmark",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":21,"phases":170,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":174,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":4},"100582085","phase-3-ripertamab-for-the-treatment-of-chronic-inflammatory-demyelinating-polyneuropathy-100582085","NCT06858722","Ripertamab for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy","Safety and Efficacy of Ripertamab in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (RIPERT-CIDP): a Randomised, Double-blind, Multicentre, Placebo-controlled Phase 3 Trial","RIPERT-CIDP","Inclusion Criteria:\n\n1. Able to understand the requirements of the trial, provide written informed consent (including consent to use and disclose health information related to the study), and willing and able to comply with the trial protocol procedures (including required trial visits);\n2. Aged 18 years or older at the time of signing the informed consent form;\n3. Diagnosed with definite CIDP according to the 2021 EFNS\u002FPNS criteria;\n4. CIDP Disease Activity Status (CDAS) score of ≥2 at screening;\n5. INCAT score of at least 2 at initial screening;\n6. Meet one of the following conditions: currently receiving oral corticosteroid therapy (equivalent to prednisone\u002F prednisolone ≤10 mg\u002Fday), and\u002For intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg), but willing to discontinue this treatment before screening; or untreated: no prior treatment; or discontinued corticosteroids and\u002For IVIg or SCIg at least 6 months before screening;\n7. Women of childbearing potential with a negative pregnancy test at screening and a negative urine pregnancy test at baseline;\n8. Women of childbearing potential must use a highly effective contraceptive method (failure rate less than 1% per year) from screening until 90 days after the last administration of the investigational medicinal product (IMP);\n9. Men who are not surgically sterile and have partners of childbearing potential must use condoms, and their partners must use a highly effective contraceptive method from screening until 90 days after the last administration of the IMP (failure rate less than 1% per year). Men who are surgically sterile (documented azoospermia following vasectomy) may be included. In addition, men must not donate sperm from screening until 90 days after the last administration of the IMP.\n\nExclusion Criteria:\n\n1. Pure sensory atypical CIDP (defined by EFNS\u002FPNS criteria);\n2. Polyneuropathy due to other causes, including but not limited to: multifocal motor neuropathy, monoclonal gammopathy of undetermined significance caused by anti-myelin-associated glycoprotein immunoglobulin M antibodies, hereditary demyelinating neuropathy, polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes syndrome, lumbosacral radiculoplexus neuropathy, polyneuropathy most likely caused by diabetes, polyneuropathy most likely caused by systemic disease, polyneuropathy caused by drugs or toxins;\n3. Any disease that can better explain the patient's symptoms and signs;\n4. History of any myelopathy or evidence of central demyelination;\n5. Current or past (within 12 months before screening) history of alcohol, drug, or substance abuse;\n6. Severe psychiatric disorder (e.g., major depression, psychosis, bipolar disorder), history of suicide attempt, or current suicidal ideation that the investigator believes may pose undue risk to the patient or affect the patient's ability to comply with the trial protocol;\n7. Clinically significant active or chronic uncontrolled bacterial, viral, or fungal infections at screening, including patients with active viral infections detected at screening: active hepatitis B virus (serological tests indicate active \\[acute or chronic\\] infection), active hepatitis C virus (HCV) (HCV-Ab seropositive), human immunodeficiency virus seropositive with acquired immunodeficiency syndrome-defining conditions or CD4 count ≤200 cells\u002Fmm³;\n8. Total immunoglobulin G level \\\u003C6 g\u002FL at screening;\n9. Received the following treatments: within 1 month before screening (or five half-lives of the drug, whichever is longer): plasmapheresis or immunoadsorption, or any other investigational product; within 6 months before screening: any anti-CD20 monoclonal antibody or other biologic (e.g., rituximab), alemtuzumab, any other monoclonal antibody, cyclophosphamide, interferon, tumor necrosis factor-α inhibitor, fingolimod, methotrexate, azathioprine, mycophenolate mofetil, any other immunomodulatory or immunosuppressive drug, and oral daily corticosteroids \\>10 mg\u002Fday (patients using IVIg, SCIg, corticosteroid pulse therapy, and oral daily corticosteroids ≤10 mg\u002Fday may be included);\n10. Pregnant and breastfeeding women, and those who plan to become pregnant during the trial or within 90 days after the last dose;\n11. Any other known autoimmune disease that the investigator believes may interfere with the accurate assessment of CIDP clinical symptoms;\n12. Received live attenuated vaccines within 28 days before screening (patients who received inactivated, subunit, polysaccharide, or conjugate vaccines at any time before screening are not considered exclusion criteria);\n13. History of malignancy, unless the patient has been free of recurrence for ≥3 years after adequate treatment before the first dose. Patients with the following cancers may be included at any time: adequately treated basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast, or prostate cancer (tumor, node, and metastasis stage T1a or T1b);\n14. Patients who have previously participated in a Ripertamab trial and received ≥1 dose of Ripertamab;\n15. Patients with a history of known hypersensitivity to any component of Ripertamab;\n16. Any other significant severe disease, or recent major surgery or planned major surgery, or any other reason that may confound trial results or pose undue risk to the patient.",{"count":169,"type":20},175,[171],"PHASE3","The goal of this clinical trial is to learn if ripertamab works to treat chronic inflammatory demyelinating polyneuropathy. It will also learn about the safety of ripertamab. The main questions it aims to answer are:\n\nDoes ripertamab reduce the risk of recurrence in patients? What medical problems do participants have when taking 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.\n\nParticipants will:\n\nA single intravenous infusion of drug ABC or placebo. 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",[29],"NOT_YET_RECRUITING","2025-02-27",{"date":177,"type":37},"2025-03-05",{"date":179,"type":20},"2025-03-15",{"date":181,"type":20},"2027-12-31",{"name":183,"class":44},"Zhongming Qiu"]