[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-inflammatory-demyelinating-polyradiculoneuropathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-inflammatory-demyelinating-polyradiculoneuropathy":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,43,74,101,121,153,178,210,232,256,284],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100599987","phase-3-a-study-to-assess-the-efficacy-and-safety-of-empasiprubart-in-adults-with-cidp-100599987",false,"NCT07091630","A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP","A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy","emnergize","Inclusion Criteria:\n\n* Meets criteria for CIDP based on EAN\u002FPNS Task Force CIDP guidelines, second revision (2021)\n* Has either typical CIDP or 1 of the following CIDP variants: motor CIDP (including motor-predominant CIDP), multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP\n* Has residual disability and active disease\n* Has not received previous treatment for CIDP; or has stopped receiving CIDP treatment; or is receiving CIDP treatment (pulsed or oral corticosteroids, immunoglobulins, PLEX, or FcRn inhibitors)\n* Participants already receiving CIDP treatment will have to discontinue their CIDP treatment before first IMP administration and must be willing to switch to the study IMP\n\nExclusion Criteria:\n\n* Meets the criteria for possible CIDP based on EAN\u002FPNS Task Force CIDP guidelines, second revision (2021)\n* Sensory CIDP (including sensory-predominant CIDP)\n* Polyneuropathy of other causes\n* Clinical diagnosis of systemic lupus erythematosus (SLE)\n* Use of other long-acting immunomodulatory treatment or prior treatment (at any time) with total lymphoid irradiation or bone marrow transplantation","ALL","18 Years",{"count":20,"type":21},160,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The main purpose of this study is to demonstrate the efficacy and safety of empasiprubart in adults with CIDP. The study consists of a part A where participants will either receive empasiprubart or placebo for 24 weeks (6 months). Following part A, participants will enter part B in which all participants will receive empasiprubart for 96 weeks (24 months).\n\nMore information can be found here: https:\u002F\u002Fclinicaltrials.argenx.com\u002Femnergize",[27,28,29],"Chronic Inflammatory Demyelinating Polyneuropathy","CIDP","Chronic Inflammatory Demyelinating Polyradiculoneuropathy","RECRUITING","2026-06-11",{"date":33,"type":34},"2026-06-12","ACTUAL",{"date":36,"type":34},"2025-09-16",{"date":38,"type":21},"2031-01-23",{"name":40,"class":41},"argenx","INDUSTRY",61,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100538384","phase-3-a-study-to-test-the-effects-and-safety-of-riliprubart-in-people-with-chronic-inflammatory-demyelinating-polyneuropathy-cidp-for-which-the-usual-treatments-do-not-work-100538384","NCT06290128","A Study to Test the Effects and Safety of Riliprubart in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) for Which the Usual Treatments do Not Work","A Phase 3, Double-blind, Placebo-controlled Study Evaluating Efficacy and Safety of Riliprubart in Participants With Refractory Chronic Inflammatory Demyelinating Polyneuropathy","MOBILIZE","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n* Participant must have CIDP or possible CIDP criteria, based on European Academy of Neurology (EAN)\u002F Peripheral Nerve Society (PNS) Task Force CIDP guidelines, second revision (2021).\n* Participant must have either typical CIDP, or one of the following two CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis Sumner Syndrome). Diagnosis must be confirmed by the adjudication committee.\n* Participant must be refractory to either immunoglobulin therapy or corticosteroid therapy, as defined below.\n\n  * Immunoglobulin-refractory subgroup: Historic evidence of failure or inadequate response to immunoglobulin therapy prior to screening\n  * Corticosteroid-refractory subgroup: Historic evidence of failure or inadequate response to corticosteroid therapy prior to screening\n* Participant has an INCAT score of 2 to 9\n* Any allowed immunosuppressant drugs (azathioprine, cyclosporine, or mycophenolate mofetil) have been taken for ≥6 months\n* Participant may be receiving low-dose oral corticosteroids (≤20 mg\u002Fday of prednisone or equivalent)\n* Participant must have active disease, defined by a CIDP disease activity score (CDAS) of ≥ 2 points at Screening\n* Participant must have documented vaccinations against encapsulated bacterial pathogens given within 5 years prior to Day 1 or initiated a minimum of 14 days prior to first dose of study intervention\n* Contraception for sexually active male or female participants; not pregnant or breastfeeding; no sperm donating for male participant\n* A body weight at Screening of 35 kg to 154 kg (77 to 340 lbs), inclusive\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Polyneuropathy of other causes, including but not limited to: acute demyelinating polyneuropathies (eg, Guillain-Barré syndrome), hereditary demyelinating neuropathies, neuropathies secondary to infection or systemic disease, diabetic neuropathy, drug- or toxin-induced neuropathies, multifocal motor neuropathy, polyneuropathy related to Immunoglobulin M (IgM) monoclonal gammopathy, POEMS syndrome, and lumbosacral radiculoplexus neuropathy.\n* Sensory CIDP, Distal CIDP and focal CIDP variants.\n* Any other neurological or systemic disease that can cause symptoms and signs interfering with treatment or outcome assessments\n* Poorly controlled diabetes\n* Serious infections requiring hospitalization within 30 days prior to Screening and any active infection requiring antimicrobial treatment during screening or presence of a condition that may predispose the participant to increased risk of infection (eg, medical history such as known immunodeficiency or history of recurrent infections)\n* Clinical diagnosis of Systemic Lupus Erythematosus (SLE) or family history of SLE. For a participant with an antinuclear antibody (ANA) titer ≥1:160 and a positive anti-double-stranded DNA (anti-dsDNA) at Screening, SLE diagnosis must be ruled out prior to enrollment.\n* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. Specifically, history of any hypersensitivity reaction to riliprubart or its components or of a severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibody.\n* Any other clinically meaningful medical history or ongoing medical condition (as determined by the Investigator at Screening) that might impact benefit-risk assessment, jeopardize the safety of the participant, or compromise the quality of the data collected in this study; or history or presence of other significant concomitant illness that would adversely affect participation in this study, per Investigator's judgment.\n* Documented history of attempted suicide over the 6 months prior to the Screening visit, presence of suicidal ideation of category 4 or 5 on C-SSRS during screening, OR if in the Investigator's judgment, the participant is at risk for a suicide attempt.\n* Evidence of CIDP worsening within the 6 weeks following a prior vaccination that, in the opinion of the Investigator, constituted a relapse\n* Recent or planned major surgery that could confound the results of the trial or put the participant at undue risk\n* Participant has recently received immunoglobulins (IVIg or SCIg)\n* Recent treatment with plasma exchange\n* Prior treatment with riliprubart\n* Prior treatment with (any time) with highly immunosuppressive\u002Fchemotherapeutic medications with sustained effects, eg, mitoxantrone, alemtuzumab, cladribine\n* Prior treatment (any time) with total lymphoid irradiation or bone marrow transplantation\n* Prior treatment with B-cell-depleting agents such as rituximab within 6 months\n* Use of any specific complement system inhibitor (eg, eculizumab) within 12 weeks or 5 times the half-life of the product, whichever is longer\n* Treatment within 6 months prior to dosing with immunosuppressive\u002F chemotherapeutic medications, such as cyclophosphamide, methotrexate, tacrolimus, interferon, or tumor necrosis factor (TNF)-α inhibitors. Certain immunosuppressants commonly used in CIDP (azathioprine, cyclosporine, or mycophenolate mofetil) are allowed, as indicated under inclusion criterion.\n* Any vaccination received within 28 days prior to dosing (with few exceptions to be confirmed at screening)\n* Participation in another clinical trial with an investigational drug or receipt of an investigational product within 12 weeks or 5 times the half-life of the product, whichever is longer, prior to Screening\n* Any screening laboratory values outside normal limits or abnormal ECG considered in the Investigator's judgment to be clinically significant in the context of this trial\n* Positive result of any of the following tests:\n\n  * Hepatitis B surface antigen (HBsAg).\n  * Anti-hepatitis B core antibodies (anti-HBc Ab) (unless anti-hepatitis B surface antibodies \\[anti-HBs Ab\\] are also positive, indicating natural immunity).\n  * Anti-hepatitis C virus (anti-HCV) antibodies (participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis RNA test is obtained).\n  * Anti-human immunodeficiency virus 1 and 2 (anti-HIV1 and anti-HIV2) antibodies.\n* Pregnancy, defined as a positive result of a highly sensitive urine or serum pregnancy test, or lactation\n* Accommodation in an institution because of regulatory or legal order; eg, imprisoned or legally institutionalized\n* Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or potential risk for noncompliance to study procedures\n* Participants are employees at the clinical study site or other individuals directly involved in the conduct of the study, or immediate family member of such individuals\n* Any country related specific regulation that would prevent the participant from entering the study\n* Recent treatment with efgartigimod\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",{"count":52,"type":21},140,[24],"The purpose of the study is to evaluate efficacy of riliprubart compared to placebo in adult participants with CIDP whose disease is refractory to standard of care. The study duration will be for a maximum of 111 weeks including screening, treatment phases, and follow-up.",[29,56],"Polyneuropathy, Inflammatory Demyelinating, Chronic",[58,59,60,61,62,63,64,65],"Autoimmune Diseases, Neurologic","Autoimmune Disorders, Nervous System","Peripheral Nerves Disease","Nervous System Diseases","Neurologic Disorders","Neurological Disorders","Complement Inhibitor","Complement Inhibitors",{"date":33,"type":34},{"date":68,"type":34},"2024-07-12",{"date":70,"type":21},"2028-11-20",{"name":72,"class":41},"Sanofi",131,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":4},"100643609","phase-2-a-study-to-assess-the-correct-dose-safety-and-efficacy-of-empasiprubart-in-adolescent-participants-aged-12-to-less-than-18-years-with-chronic-inflammatory-demyelinating-polyradiculoneuropathy-100643609","NCT07638566","A Study to Assess the Correct Dose, Safety and Efficacy of Empasiprubart in Adolescent Participants Aged 12 to Less Than 18 Years With Chronic Inflammatory Demyelinating Polyradiculoneuropathy","An Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Empasiprubart in Adolescent Participants Aged 12 to Less Than 18 Years With Chronic Inflammatory Demyelinating Polyradiculoneuropathy","emlight","Inclusion Criteria:\n\n* Is aged 12 to \\\u003C18 years.\n* Meets criteria for CIDP based on EAN\u002FPNS Task Force CIDP guidelines, second revision (2021).\n* Has a diagnosis of either typical CIDP or 1 of the following CIDP variants: motor CIDP (including motor-predominant CIDP), multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP.\n\nExclusion Criteria:\n\n* Possible CIDP based on EAN\u002FPNS Task Force CIDP guidelines, second revision (2021).\n* Sensory CIDP (including sensory-predominant CIDP).\n* Besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of CIDP, or that puts the participant at undue risk.\n* Prior use of other long-acting immunomodulatory treatment.","12 Years","17 Years",{"count":85,"type":21},6,[87,24],"PHASE2","The main purpose of the study is to determine the correct dose of empasiprubart in adolescent participants. It also aims to evaluate if empasiprubart may work and how safe it is for the use in children living with CIDP.\n\nThe study consists of an open label treatment phase where participants will receive empasiprubart for up to 27 months approximately. After the final dose of empasiprubart, participants will enter a safety follow-up period for up to 14 months approximately.\n\nThe overall study duration for each participant is up to 43 months.\n\nMore information can be found here: clinicaltrials.argenx.com\u002Femlight",[29,90,28,91],"CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)","Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)","NOT_YET_RECRUITING","2026-06-05",{"date":95,"type":34},"2026-06-10",{"date":97,"type":21},"2026-09",{"date":99,"type":21},"2031-08",{"name":40,"class":41},{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":109,"phases":4,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},"100613272","real-world-efgartigimod-effectiveness-in-cidp-a-prospective-study-100613272","NCT07264426","Real-World Efgartigimod Effectiveness in CIDP: A Prospective Study","Inclusion Criteria:\n\n* Aged ≥18 years at time of providing informed consent\n* Diagnosed with CIDP\n* Planned to be receiving efgartigimod treatment within the CIDP treatment label of efgartigimod in the participant's respective country\n* Efgartigimod treatment-naïve at time of screening\n\nExclusion Criteria:\n\n* Polyradiculoneuropathy due to any other cause(s)\n* Current participation in any interventional clinical study at time of screening, or planned participation before initiation of efgartigimod",{"count":108,"type":21},200,"OBSERVATIONAL","The aims of this study are to assess the real-world effectiveness of efgartigimod in treating chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), describe the \"treatment journey\" of participants with CIDP, and assess the utilization of health care services among adult participants with CIDP who initiate treatment with efgartigimod.\n\nAs this is a noninterventional study, treatment choices and decisions will be left to the discretion of participants and their physicians, according to the standard of care.\n\nEach participant will be prospectively followed for up to 2 years from the date of initial administration of efgartigimod.",[29,28,90],"2026-04-22",{"date":114,"type":34},"2026-04-23",{"date":116,"type":34},"2025-08-11",{"date":118,"type":21},"2029-10",{"name":40,"class":41},23,{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":128,"enrollmentInfo":129,"targetDuration":131,"studyType":109,"phases":4,"briefSummary":132,"conditions":133,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":152},"100618559","tongji-nads-cohort-100618559","NCT07333196","Tongji NADs Cohort","Tongji NADs Cohort: A Real-world Observation of Neurological Autoimmune Disorders","Inclusion Criteria:\n\n* Participants must meet the following eligibility criteria at the time of screening to participate in this study.\n\n1.1. The subject is able to understand the purpose and risks of the study, provide informed consent and authorize the use of confidential health information in accordance with national and local privacy regulations.\n\n1.2. Open to both men and women, aged 18-80 years (inclusive) at the time of informed consent.\n\n1.3. Must be diagnosed with one of the following conditions:\n\n1.3.1. This study adhered to the 2017 McDonald criteria for diagnosing multiple sclerosis:\n\n1. ≥2 clinical episodes with ≥2 objective clinical evidences of lesions.\n2. ≥2 clinical episodes with one clear historical evidence of the lesion involving specific anatomical site.\n3. ≥2 clinical episodes with objective clinical evidence of one lesion, and spatial multiplicity confirmed by clinical episodes in different CNS sites or MRI findings.\n4. A single episode with ≥2 objective clinical evidences, confirmed by additional clinical episodes or MRI showing temporal multiple lesions or OCB positivity.\n5. A single episode with one objective clinical manifestation, confirmed by clinical seizures or MRI scans across multiple CNS regions to demonstrate spatial multiplicity, and further supported by additional clinical episodes or MRI findings to confirm temporal multiplicity or OCB positivity.\n6. Indication for the progressive multifocal sclerosis (PPMS) phase: Disease progression at 1 year (confirmed retrospectively or prospectively), with two of the following three criteria: \\[1\\] Spatially multifocal evidence of brain lesions: ≥1 T2-weighted lesion in characteristic MS regions (periventricular, corticoprotuberant, or subarachnoid) \\[2\\] Spatially multifocal evidence of spinal lesions: ≥2 T2-weighted lesions in the spinal cord \\[3\\] OCB positivity.\n\n1.3.2. This study adhered to the 2015 IPND diagnostic criteria for adult neuromyelitis optica spectrum disorders:\n\n1. NMOSD diagnosis with AQP4-IgG positivity: meeting ≥1 core clinical feature, confirmed by reliable AQP4-IgG detection (CBA method recommended), and excluding other diagnoses.\n2. Diagnostic criteria for NMOSD with AQP4-lgG negative or undetermined status: In at least one clinical episode, the presence of ≥2 core clinical features meeting all of the following criteria: ①≥1 core clinical feature is ON, acute LETM, or bulbar syndrome; ②≥2 distinct core clinical features; ③MRI supplementary criteria are satisfied. AQP4-lgG should be reliably detected as negative or undetected, and other diagnoses must be excluded.\n\nNote: Core clinical features include six cardinal signs: optic neuritis (ON), acute myelitis (LETM), and the final area syndrome (unexplained paroxysmal hiccups, nausea, and vomiting); other brainstem syndromes; symptomatic narcolepsy\u002Fhypothalamic syndrome with characteristic hypothalamic MRI lesions; and brain syndrome with characteristic cerebral MRI lesions.\n\nMRI diagnostic criteria: Acute optic neuritis (ON) requires MRI demonstrating one of the following: ① Normal brain MRI or non-specific white matter lesions; ② Long T-weighted signal or T-weighted enhancement exceeding 1\u002F2 of optic nerve length, or optic chiasm involvement; ③ Acute myelitis (LETM) requires three or more consecutive vertebral segments with spinal cord lesions, or spinal cord atrophy exceeding three consecutive vertebral segments in patients with myelitis history; ④ Final region syndrome: lesions in the dorsal medulla or final region. Acute brainstem syndrome: periventricular lesions in the brainstem.\n\n1.3.3. This study adhered to the MOGAD diagnostic criteria established by the International Parkinson's Disease and Movement Disorders (IPMD) in 2023:\n\n1. A diagnosis of MOGAD can be confirmed when: (a) fixed or live-cell CBA detects strong positivity of MOG-IgG in serum with ≥1 core clinical manifestation, and (b) other diagnoses (e.g., MS, NMOSD) are excluded;\n2. If the CBA shows weak positivity of MOG-IgG in serum, or MOG-IgG positivity without titer, or negative serum MOG-IgG with strong positivity in cerebrospinal fluid (CSF), the diagnosis requires: 1) ≥1 core clinical manifestation, 2) ≥1 supporting clinical or imaging feature, 3) negative serum AQP4-IgG, and 4) exclusion of other diagnoses (e.g., MS, NMOSD).\n\nNote: The core clinical features include six main signs: optic neuritis, myelitis, acute disseminated encephalomyelitis, monofocal or multifocal cerebral dysfunction, brainstem or cerebellar functional deficits, and cerebral cortex inflammation with epilepsy.\n\nTypical MRI imaging features: ① Optic Neuropathy (ON): Bilateral optic nerve involvement with long-segment optic nerve damage (\\>50% optic nerve length), optic nerve sheath enhancement, and papilledema. ② Myelitis: Long-segment transverse myelitis with central spinal cord damage or \"H\" sign, and conus medullaris damage. ③ Cerebral, brainstem, or cerebral cortex symptoms: Multifocal ill-defined T2 hyperintense lesions in supratentorial and infratentorial white matter, deep gray matter involvement, ill-defined T2 hyperintense lesions in pons, cerebellar midfoot, or medulla oblongata, and cortical lesions with or without focal enhancement and local dural enhancement.\n\nThe strong positive result of serum and cerebrospinal fluid MOG-IgG was defined as the value of the live CBA was more than 2 times the detection limit or the fixed CBA titer was ≥1:100. The weak positive result was defined as the value of the live CBA was in the lower range or the fixed CBA titer was ≥1:10 but less than 1:100.\n\n1.3.4. This study followed the expert consensus on the diagnosis and treatment of autoimmune encephalitis in China (2022 edition)\n\n1. Possible AE: meeting the following three diagnostic criteria A, B, and D; confirmed AE: meeting the four diagnostic criteria A, B, C, and D.\n2. Diagnostic criteria:\n\nA. Clinical presentation: Acute or subacute onset (\\\u003C3 months) with ≥1 of the following neurological or psychiatric symptoms or clinical syndromes: limbic system symptoms, encephalitis syndrome, lymphocytic inflammation in cerebrospinal fluid cytology, and positive specific oligoclonal bands.\n\nB. Neuroimaging or electrophysiological abnormalities: T2 or FLAIR abnormal signals in the limbic system (unilateral or bilateral), or T2\u002FFLAIR abnormalities in other regions (excluding nonspecific white matter changes and stroke); or PET findings of high metabolism in the limbic system, or multiple high metabolic areas in the cortex and\u002For basal ganglia; or EEG abnormalities such as focal epilepsy or epileptiform discharges (in the temporal lobe or outside it), or diffuse or multifocal slow-wave rhythms.\n\nC. Diagnostic test: Positive for anti-neuronal antibodies. D. Reasonably rule out other possible causes.\n\n1.3.5. This study adhered to the diagnostic criteria for AIDP, CIDP, and autoimmune Ranvier node disease:\n\n1. AIDP: Essential features include: ① Progressive weakness in the upper and\u002For lower limbs, ranging from mild bilateral lower limb weakness to complete paralysis of all limbs (including trunk, medullary muscles, and facial muscles) and oculomotor muscle paralysis; ② Weakened or absent deep tendon reflexes in the affected limbs; ③ Symptom progression ≤4 weeks. Supporting features include: ① Symptom progression from days to 4 weeks; ② Relatively symmetrical bilateral symptoms; ③ Trunk or limb pain; ④ Cranial nerve symptoms or signs; ⑤ Autonomic dysfunction; ⑥ Respiratory insufficiency; ⑦ Mild or absent sensory dysfunction; ⑧ History of prodromal systemic infection in approximately 70% of cases; ⑨ No fever at symptom onset; ⑩ Elevated cerebrospinal fluid protein with normal or mildly elevated white blood cell count (\\\u003C5 mm³); ⑪ Electrophysiological examination showing abnormalities consistent with Guillain-Barré syndrome (GBS); ⑫ Recovery begins 2-4 weeks after symptom stabilization.\n2. CIDP: CIDP develops in 2%-5% of patients initially diagnosed with AIDP, with the following clinical features: ① Progressive or recurrent disease progression lasting over 8 weeks; ② Only approximately 30% of patients experience prodromal events; ③ Additional supporting features include: ≥3 acute relapses or exacerbations occurring ≥8 weeks after symptom onset, milder symptoms, preserved independent walking ability throughout the disease course, and absence of cranial nerve involvement or frequent respiratory system involvement.\n3. Autoimmune Ranvier node disease:\n\n   * Clinical manifestations: a. Acute, subacute or chronic course, with persistent progression after 8 weeks of onset; b. Clinical features consistent with polyneuropathy; c. May be accompanied by significant ataxia, tremor or neuropathic pain; d. May be associated with nephrotic syndrome.\n   * Electrophysiological findings: a. Motor nerve conduction tests reveal prolonged distal motor latency, slowed conduction velocity, abnormal waveform dispersion, and conduction block, with decreased F-wave conduction velocity, consistent with myelination abnormalities; b. Both motor and sensory nerve conduction show markedly reduced amplitude. Electromyography (EMG) at needle electrodes demonstrates abnormal spontaneous potentials and decreased recruitment, indicating early axonal damage.\n   * Antibody detection: serum anti-Langfei junction antibody was positive, especially serum anti-NF155, anti-CNTN1, anti-Casp1 and anti-NF140\u002F186 antibody.\n   * Cerebrospinal fluid (CSF) analysis: Protein-cell dissociation is observed, with CSF protein levels typically showing significant elevation.\n\n1.3.6. This study adheres to the diagnostic criteria of the 2024 China Expert Consensus on the Diagnosis and Treatment of Refractory Systemic Myasthenia Gravis\n\n1. Basic conditions\n\n   ① Meet the diagnostic criteria in the China Guidelines for the Diagnosis and Treatment of Myasthenia Gravis (2025 edition).\n\n   ② The patient's Myasthenia Gravis Activities of Daily Living (MG-ADL) score was ≥6, and the ocular muscle score was less than 50% of the total score.\n2. Diagnostic criteria:\n\n   * After adequate duration of treatment with at least two conventional immunotherapeutic agents (including both corticosteroids and non-corticosteroid immunosuppressants), the post-intervention status (PIS) remains unchanged or worsens.\n   * After adequate doses and duration of at least two conventional immunotherapeutic drugs, the PIS showed improvement, but the MG-ADL score remained ≥6 points for at least six months.\n   * After adequate duration of treatment with at least two conventional immunotherapeutic agents, the PIS was remitted or improved, but during the regular tapering of immunotherapy, disease symptoms worsened ≥2 times per year (MG-ADL score ≥6).\n   * Patients who, after a crisis, received multiple immunotherapies including intravenous immunoglobulin (IVIG), plasma exchange, and high-dose intravenous methylprednisolone (IVMP), along with active infection control, still remained unable to wean off mechanical ventilation for more than 14 days due to MG-induced respiratory muscle weakness.\n\nDiagnostic criteria: meeting all the above basic conditions plus 1 of the 4 diagnostic conditions.\n\n1.3.7. This study adheres to the 2017 diagnostic criteria for idiopathic inflammatory myopathy (IIM) established by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR), following the EULAR\u002FACR classification system. Patients with a probability score ≥55% in the table below are considered suspected IIM cases. Suspected IIM patients can be diagnosed with dermatomyositis in adults if they meet the following criteria: ① Age ≥18 years at first onset of IIM-related symptoms; ② Presence of Heliotrope sign, Gottron papules, or Gottron sign; ③ Objective proximal symmetrical arm weakness (confirmed by manual muscle strength testing or other strength assessment methods), typically progressive, or objective proximal symmetrical leg weakness, typically progressive, or more pronounced neck flexor weakness than neck extensor weakness, or more pronounced proximal leg weakness than distal leg weakness. If patients meet criteria ① and ② but not ③, they may be diagnosed with non-myopathic dermatomyositis. Compared to previous standards, this criterion demonstrates higher sensitivity and specificity. In this standard, patients with typical clinical manifestations (such as characteristic rashes) do not require further tests (e.g., muscle biopsy), while some patients without typical rashes may be missed.\n\nExclusion Criteria:\n\n* This is an observational study with no specific exclusion criteria.\n* The investigators identified other unexplained factors that may have disqualified participants from enrollment.","80 Years",{"count":130,"type":21},1550,"10 Years","Neurological Autoimmune Diseases (NADs) are disorders caused by abnormal immune system attacks on neural tissues, affecting multiple systems including the central nervous system, peripheral nervous system, and neuromuscular junctions. This study examines clinically significant NADs such as multiple sclerosis (MS), neuromyelitis optica spectrum disorders (NMOSD), myelin oligodendrocyte glycoprotein G antibody-related diseases (MOGAD), autoimmune encephalitis (AE), immune-mediated peripheral neuropathy (PN), myasthenia gravis (MG), and idiopathic inflammatory myopathy (IIM). While sharing the core pathogenesis of autoimmune response, these diseases exhibit significant heterogeneity in epidemiological patterns, clinical manifestations, therapeutic approaches, and disease progression. This heterogeneity stems from multiple factors: (1) Differences in immune targets: MS primarily involves T-cell-mediated myelin attack, NMOSD is mainly driven by astrocyte damage caused by anti-AQP4 antibodies, MOGAD results from myelin surface loss mediated by antibodies against myelin oligodendrocyte glycoprotein immunoglobulin G, while AE involves synaptic dysfunction due to antibodies against neuronal surface proteins (e.g., anti-NMDA-R antibodies); (2) Genetic-environmental interactions: MS is more prevalent in European and American populations, whereas NMOSD is more aggressive in Asian populations; (3) Variability in treatment response: Some diseases respond well to immunomodulatory therapy, but most still face challenges such as high relapse rates, progressive disability accumulation, and irreversible neurological damage.\n\nWhile randomized controlled trials (RCTs) provide high-quality core evidence for drug registration, their strict inclusion\u002Fexclusion criteria, relatively homogeneous patient populations, and short-term observation designs often fail to fully capture the complex disease progression and treatment response patterns in real-world clinical settings. Additionally, long-term RCTs are frequently constrained by economic factors and sustainability challenges. Therefore, conducting comprehensive real-world observational studies (RWS) on NADs-integrating multi-disease cohorts, long-term follow-up data, and diverse clinical practices-holds significant scientific and clinical value for optimizing treatment strategies and improving long-term patient outcomes.",[134,135,136,137,138,139,29,140,141],"Multiple Sclerosis","NMO Spectrum Disorder","Autoimmune Encephalitis","Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease","Autoimmune Nodopathy","Acute Inflammatory Demyelinating Polyradiculoneuropathy","Myasthenia Gravis","Idiopathic Inflammatory Myopathies","2026-01-17",{"date":144,"type":34},"2026-01-21",{"date":146,"type":21},"2026-03-01",{"date":148,"type":21},"2037-03-01",{"name":150,"class":151},"Tongji Hospital","OTHER",1,{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":22,"phases":162,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":152},"100588266","early-phase-1-universal-chimeric-antigen-receptor-t-cell-ucar-t-cell-therapy-targeting-cd19b-cell-maturation-antigen-cd19bcma-in-patients-with-rr-neurological-autoimmune-diseases-100588266","NCT06939166","Universal Chimeric Antigen Receptor T-Cell （UCAR T-cell） Therapy Targeting CD19\u002FB Cell Maturation Antigen （CD19\u002FBCMA） in Patients With r\u002Fr Neurological Autoimmune Diseases","A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapsed \u002F Refractory Neurological Autoimmune Diseases","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Flow cytometry detected positive B cell CD19 or BCMA in the patient's peripheral blood.\n* Subjects with relapsed or refractory neurological autoimmune diseases, Including neuromyelitis optica spectrum disorders(NMOSD), myasthenia gravis(MG), multiple sclerosis(MS)，Autoimmune encephalitis(AE) and chronic inflammatory demyelinating Polyradiculoneuropathy(CIDP).\n* Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or 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 Human chorionic gonadotropin (HCG) test within 7 days before study enrollment and not be lactating.\n* Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n* Subjects with a history of severe drug allergies or allergic tendencies.\n* History of malignancy within five years.\n* Subjects with insufficient cardiac function.\n* Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA \\>the upper limit of detection; subjects positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; individuals positive for human immunodeficiency virus (HIV) antibody; individuals positive for syphilis testing.\n* Pregnant women or women planning to conceive.",{"count":161,"type":21},12,[163],"EARLY_PHASE1","This is an open label, single-site, dose-escalation study in up to 12 participants with relapsed or refractory Neurological Autoimmune Diseases. This study aims to evaluate the safety and efficacy of the treatment with universal CD19\u002FBCMA CAR T-cells.",[166,140,134,29,136],"Neuromyelitis Optica Spectrum Disorders",[168],"Universal Allogeneic CAR T-cells","2025-12-11",{"date":171,"type":34},"2025-12-15",{"date":173,"type":34},"2025-06-17",{"date":175,"type":21},"2027-10",{"name":177,"class":151},"Tianjin Huanhu Hospital",{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":185,"sex":17,"minAge":18,"maxAge":186,"enrollmentInfo":187,"targetDuration":189,"studyType":109,"phases":4,"briefSummary":190,"conditions":191,"keywords":196,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":152},"100563396","our-study-aims-to-determine-if-nerve-alterations-in-acute-gbs-and-cidp-detectable-by-ultrasound-match-electrodiagnostic-findings-and-if-this-method-aids-early-diagnosis-predict-their-outcomes-and-differentiate-between-axonal-and-demyelinating-subtypes-100563396","NCT06615622","Our Study Aims to Determine if Nerve Alterations in Acute GBS and CIDP Detectable by Ultrasound Match Electrodiagnostic Findings and if This Method Aids Early Diagnosis, Predict Their Outcomes and Differentiate Between Axonal and Demyelinating Subtypes.","A Comparative Study of Peripheral Nerve Ultrasound Findings in Immune Mediated Peripheral Nerve Disorders; a Hospital-based Study","Inclusion Criteria:\n\n1. Diagnosis of patient group:\n\n   * GBS Patients: Diagnosed according to the criteria of the National Institute of Neurological Disorders and Stroke (NINDS) and the Brighton Collaboration (2011).\n   * CIDP Patients: Diagnosed according to the criteria of the European Federation of Neurological Societies\u002FPeripheral Nerve Society (EFNS\u002FPNS).\n2. Age: Participants aged 18 to 75 years.\n3. Onset:\n\n   * GBS Patients: Recent onset of GBS within the first 2 weeks of symptom onset.\n   * CIDP Patients: Either relapsing or progressive course consistent with CIDP diagnosis.\n4. Gender: Both male and female participants are eligible.\n5. Participation: Willingness to participate in the study, including undergoing disease-related examinations and assessments.\n6. Consent: Ability and willingness to provide informed consent\n\nExclusion Criteria:\n\n1. Patients unable or unwilling to provide informed consent.\n2. Patients with metabolic disorders or malignancies.\n3. Patients with other causes of peripheral neuropathy.\n4. Patients with other causes of acute flaccid paralysis.",true,"75 Years",{"count":188,"type":21},90,"6 Months","Neuromuscular ultrasound (NMUS) is emerging as a valuable non-invasive diagnostic tool. In GBS, NMUS can detect proximal nerve enlargement early, before neurophysiological changes. Persistent nerve enlargement can be observed up to 15 years, though its correlation with disability varies. Research is needed to clarify NMUS findings in GBS and CIDP over time. Early detection of nerve root enlargement via NMUS could facilitate earlier diagnosis and intervention, improving patient outcomes and understanding of these conditions\\' pathophysiology.\n\nThis study aims to determine if nerve alterations in acute GBS and CIDP detectable by ultrasound match electrodiagnostic findings and if this method aids early diagnosis. The investigators will perform serial nerve ultrasounds and NCS to investigate nerve morphology, predict outcomes, and differentiate between axonal and demyelinating subtypes.",[192,29,193,194,195],"Guillain Barré Syndrome","Peripheral Nerve Disorder","Peripheral Nerves US","Peripheral Neuropathy",[197,198,199,200],"Peripheral nerve ultrasound","immune mediated nerve disorders","Guillain-Barré syndrome","Chronic inflammatory demyelinating polyradiculoneuropathy","2025-10-01",{"date":203,"type":34},"2025-10-03",{"date":205,"type":34},"2024-09-01",{"date":207,"type":21},"2028-03-30",{"name":209,"class":151},"Assiut University",{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":216,"enrollmentInfo":217,"targetDuration":4,"studyType":22,"phases":219,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":152},"100594649","phase-1-safety-and-efficacy-of-baff-r-cart-for-refractory-neuroimmune-diseases-100594649","NCT07022197","Safety and Efficacy of BAFF-R CART for Refractory Neuroimmune Diseases","Inclusion Criteria:\n\n1\\. Assessed by the investigator as having a refractory neuroimmune disease;\n\nRefractory neuroimmune diseases were defined as:\n\n1. Poor symptom control on at least three immunosuppressive agents for more than one year;\n2. Clinical evidence of at least two relapses within 12 months or three relapses within 24 months and one relapse within 12 months prior to screening.\n\n2\\. Male study participants must agree to use contraception during the treatment period for 1 year after receiving study treatment, and sperm donation is prohibited throughout the study period;\n\n3\\. In the case of females with childbearing potential, need to agree to use contraception during the treatment period and for at least 1 year after receiving study treatment. Participants must have a negative serum pregnancy test result at screening and a confirmed negative urine pregnancy test result prior to first CART treatment.\n\nExclusion Criteria:\n\n1. Any medical or psychiatric condition that, in the opinion of the investigator, may jeopardize the study participant or affect the study participant's ability to participate in this study;\n2. A history of drug or alcohol abuse within the 12 months prior to baseline, or any condition that in the opinion of the investigator is associated with poor adherence;\n3. Women who are breastfeeding or pregnant, or who plan to become pregnant at any time during the 12-month time period following treatment with CART, or a history of spontaneous or induced abortion within 4 weeks prior to screening;\n4. Study participants with a clinically relevant active infection (e.g., sepsis, pneumonia, or abscess) or serious infection (resulting in hospitalization or requiring antibiotic therapy) within 4 weeks prior to baseline;\n5. The study participant has received a live attenuated vaccination within 8 weeks prior to baseline; or is scheduled to receive a live vaccination (including COVID-19 vaccine) within 8 weeks after treatment;\n6. Study participants who have received prior treatment with rituximab within 6 months prior to baseline;\n7. Study participants had received tolizumab, eculizumab within 3 months prior to baseline;\n8. Study participants who have received intravenous human immunoglobulin, plasma exchange, undergone immunotherapy within 4 weeks prior to baseline;\n9. Known concomitant serious underlying diseases, such as hepatic and renal impairment, hematologic disorders, previous severe cardiovascular disease, severe hypertension, diabetes mellitus, poor control of blood pressure and blood glucose;\n10. Comorbid mental illness, suicidal ideation (affirmative answer (yes) to question 4 or question 5 of the Colombian Suicide Severity Rating Scale (C-SSRS) indicating a suicide attempt within the last 6 months);\n11. Any of the following laboratory abnormalities during the screening period (a repeat measurement may be taken during the screening period prior to randomization to confirm results); (1) Elevated liver enzymes: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 3 times the upper limit of normal (ULN); (2) Total bilirubin \\> 1.5 times the ULN; (3) Estimated glomerular filtration rate (eGFR) \\\u003C45 mL\u002Fmin\u002F1.73 m2; (4) CD19 + B cell count \\\u003C40 cells\u002FµL;\n12. Presence of a history of tuberculosis infection, high risk of acquired tuberculosis infection;\n13. known immunodeficiency diseases, including human immunodeficiency virus (HIV) infection;\n14. Viral hepatitis B surface antigen (HBsAg) positivity during the screening period;\n15. Receiving blood transfusion therapy 4 weeks prior to baseline or during the screening period;\n16. Any other condition that the investigator deems inappropriate for participation in the study.","60 Years",{"count":218,"type":21},27,[220,87],"PHASE1","This study is a phase Ib\u002FIIa dose-escalation study designed to evaluate the safety, tolerability, and preliminary efficacy of autologous T cells expressing chimeric antigen receptor (CAR)-targeted B-cell activating factor receptor (BAFFR) in refractory neuroimmune diseases. The study design is divided into two parts, the first of which will be given to each patient at 3 incremental dose levels to establish the maximum tolerated dose (MTD). Each disease is expected to enroll 12 patients who meet the inclusion criteria. In the second part, 15 patients per disease will be recruited to further characterize the efficacy of the MTD.",[29,135,140,141],"2025-06-06",{"date":225,"type":34},"2025-06-15",{"date":227,"type":34},"2025-04-10",{"date":229,"type":21},"2027-12-30",{"name":231,"class":151},"Tianjin Medical University General Hospital",{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":186,"enrollmentInfo":239,"targetDuration":4,"studyType":22,"phases":241,"briefSummary":242,"conditions":243,"keywords":245,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":152},"100553372","early-phase-1-universal-car-t-cells-in-patients-with-refractory-autoimmune-diseases-of-the-nervous-system-100553372","NCT06485232","Universal CAR-T Cells in Patients with Refractory Autoimmune Diseases of the Nervous System.","An Exploratory Study on the Safety and Efficacy of Universal CAR-T Cells Targeting BCMA and CD19 in the Treatment of Refractory Autoimmune Diseases of the Nervous System","Inclusion Criteria:\n\n* Aged 18-75 years (for MS patients, 18-55 years); both genders eligible.\n* Subjects with refractory neurological autoimmune diseases who have failed standard treatment or lack effective treatment, Including neuromyelitis optica spectrum disorders(NMOSD), generalized myasthenia gravis(gMG), chronic inflammatory demyelinating Polyradiculoneuropathy(CIDP) and multiple sclerosis(MS).\n* Anticipated survival of ≥ 12 weeks as judged by the researcher.\n* Agrees to use double barrier methods, condoms, oral or injectable contraceptives, or intrauterine devices during the study period and for one year after taking the study medication.\n* Provides written informed consent.\n\nExclusion Criteria:\n\n* History of solid organ transplantation.\n* Malignant tumor within the last two years.\n* Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb), with peripheral blood Hepatitis B virus (HBV) DNA detected as positive; positive for Hepatitis C virus antibodies, with peripheral blood Hepatitis C virus RNA detected as positive; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for Cytomegalovirus (CMV) DNA; positive for syphilis.\n* Primary immunodeficiency (congenital or acquired).\n* Severe cardiac disease.\n* History of psychiatric disorders or history of psychotropic drug abuse, with no history of withdrawal.\n* Allergic constitution or a history of severe allergies.\n* Pregnant or breastfeeding women.",{"count":240,"type":21},25,[163],"This is an open label, single-site, dose-escalation study in up to 25 participants with refractory autoimmune diseases of nervous system. This study aims to evaluate the safety and efficacy of the treatment with universal BCMA and CD19 CART.",[166,244,134,29],"Myasthenia Gravis, Generalized",[246,166,140,134,29],"universal CAR-T","2024-12-30",{"date":249,"type":34},"2025-01-01",{"date":251,"type":21},"2025-02-28",{"date":253,"type":21},"2027-12-31",{"name":255,"class":151},"Xuanwu Hospital, Beijing",{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":185,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":109,"phases":4,"briefSummary":265,"conditions":266,"keywords":273,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":152},"100554663","biomarkers-in-autoimmune-disease-of-nervous-system-100554663","NCT06502015","Biomarkers in Autoimmune Disease of Nervous System","Biomarkers of Neurological Autoimmune Diseases","Inclusion Criteria:\n\n* Clinical diagnosis with autoinflammatory diseases of the nervous system, including: Neuromyelitis Optica Spectrum Disorder (NMOSD), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), idiopathic inflammatory myopathy(IIM), multiple sclerosis (MS), autoimmune encephalitis (AE), Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD), ect al.\n* sex and age-matched healthy individuals\n\nExclusion Criteria:\n\n* Known history of primary immunodeficiency (innate or acquired).\n* Patients with severe central nervous system, pulmonary, or other systemic infections.\n* Patients with secondary central nervous system demyelinating lesions, such as those caused by vasculitis, systemic lupus erythematosus, and Sjögren's syndrome.\n* Patients with vascular (including hemorrhagic and ischemic), hereditary metabolic, neoplastic, or toxic diseases.\n* Pregnant or lactating women.",{"count":264,"type":21},50000,"Neurological autoimmune diseases are a group of disorders characterized by the abnormal immune response attacking the nervous system, including the brain, spinal cord and peripheral nerves. These diseases exhibit high heterogeneity, diverse clinical presentations, and are challenging to diagnose and manage due to a lack of effective treatments. In this study, the investigators will recruit eight kinds of autoimmune diseases of nervous system including Neuromyelitis Optica Spectrum Disorder (NMOSD), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), idiopathic inflammatory myopathy (IIM), and multiple sclerosis (MS), autoimmune encephalitis (AE), Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD). Through this study, the investigators aim to discover biomarkers with high sensitivity, specificity, and stability, which can support early diagnosis, disease monitoring, and personalized treatment for neurological autoimmune diseases, thereby improving the quality of life and prognosis for patients.",[267,268,134,269,270,136,271,140,29,141,272],"Autoimmune Diseases of the Nervous System","Neuromyelitis Optica Spectrum Disorder","Guillain-Barre Syndrome","Acute Disseminated Encephalomyelitis","Stiff-Person Syndrome","Autoimmune Diseases",[274,267,275],"Biomarker","Immune cell","2024-11-17",{"date":278,"type":34},"2024-11-20",{"date":280,"type":34},"2024-07-31",{"date":282,"type":21},"2027-07",{"name":150,"class":151},{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":290,"eligibilityCriteria":291,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":186,"enrollmentInfo":292,"targetDuration":4,"studyType":22,"phases":294,"briefSummary":295,"conditions":296,"keywords":299,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":152},"100405605","early-phase-1-safety-and-efficacy-of-ct103a-cells-for-relapsedrefractory-antibody-associated-inflammatory-diseases-of-the-nervous-system-100405605","NCT04561557","Safety and Efficacy of CT103A Cells for Relapsed\u002FRefractory Antibody-associated Inflammatory Diseases of the Nervous System","An Open Label Clinical Trial to Evaluate the Safety and Efficacy of CT103A Cells for the Treatment of Relapsed\u002FRefractory Antibody-associated Inflammatory Diseases of the Nervous System","CARTinNS","Inclusion Criteria:\n\n1. Male or female subjects aged 18-75 years (including 18 and 75 years);\n2. Subjects with Relapsing\u002Frefractory Antibody-mediated inflammatory diseases of the nervous system without effective treatment, including:\n\n   1. Subjects must be diagnosed as AQP4-IgG-positive NMOSD defined by 2015 criteria of IPND NMOSD and meet the following requirements: i. At least one kind of immunosuppressant has been used for more than one year with poorly-controlled symptoms; ii. Clinical evidence of at least two relapses in the last 12 months or three relapses in the last 24 months and one relapse in the preceding 12 months before screening.\n   2. Subjects with MG with positive abnormal antibody, MG-ADL total score ≥ 6 points, MGFA classification II-IV defined by 2020 MGFA diagnostic criteria and meet the following requirement: i. At least one kind of immunosuppressant for standardized treatment for more than 1 year, and have one of the following poor control conditions: 1) continuous inability to affect daily life; 2) Exacerbation of MG symptoms and\u002For crisis attacks still occur despite standard treatment; 3) Inability to tolerate immunosuppressive therapy ii. Requires plasma exchange or maintenance therapy with IV gamma globulin\n   3. Subjects with CIDP with positive abnormal antibodies, INCAT disability scale with total score of 2-9 defined by 2021 EAN\u002FPNS diagnostic criteria and meet the following requirement: i. Standardized use of at least one first-line therapy for more than 3 months (cortisol hormone therapy, gamma globulin or plasma exchange therapy) with poorly-controlled symptoms. ii. Inability to tolerate cortisol hormones, gamma globulin, and plasmapheresis because of side effects or other conditions\n   4. Subjects were diagnosed with IIM defined by 2017 European League against Rheumatism\u002FAmerican Rheumatology (EULAR\u002FACR) conference Class criteria; At least one kind of cardiac enzymes (CK, AST, ALT, ALD, LDH) ≥1.5×ULN during the screening period, or Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) ≥6, or at least one other sign of active disease within the last 6 months: MRI, EMG, or muscle biopsy; positive serological tests for myositis-specific antibodies (MSA) or myositis-associated autoantibodies (MAA), or antinuclear antibody (ANA). and meet one of the following requirements:\n\n   i. After at least 1 month of corticosteroid therapy and standardized use of at least one immunosuppressant\u002Fmodulator (eg, azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, tacrolimus, Cyclophosphamide, leflunomide, intravenous gamma globulin, etc.) for more than 3 months with poorly-controlled symptoms.\n\n   ii. ii. Inability to tolerate the above traditional regimens due to side effects or other conditions;\n\n   e. Subjects were diagnosed with PMS (including PPMS and SPMS) or RMS according to the 2017 revision of the McDonald diagnostic criteria；EDSS score between 2 to 7 points inclusive, at screening. Subjects with RMS should meet one of the following requirements after standard therapy: i. at least two relapses in the last two years before screening. ii. at least one relapse in the last one year before screening. iii. positive Gd-enhancing MRI in the last one year before screening.\n\n   f. Subjects were diagnosed with POEMS syndrome according to the 2021 revised IMWG diagnostic criteria and meet all of the following requirements: i. bone marrow involvement; ii. no response to traditional regimens treatment including corticosteroid, chemotherapy, protease inhibitor or inability to tolerate the above traditional regimens; iii. Have measurable lesions (refer to the 2021 revised IMWG standard) iv. VEGF \\> 2 ULN; v. ECOG score ≥1; vi. ONLS score ≥1.\n\n   g. Subjects were diagnosed with autoimmune encephalitis according to the 2016 International Diagnostic Criteria for Autoimmune Encephalitis and meet all of the following requirements: i. at least one pathogenic antibody positive; ii. previously standardized use of corticosteroid, at least one immunosuppressant\u002Fmodulator, including CD20 monoclonal antibody with poorly-controlled symptoms or intolerance; iii. onset of autoimmune encephalitis within 3 months prior to screening; iv. mRS Score ≥2 or CASE score ≥4.\n\n   h. Subjects were diagnosed with MOGAD according to the 2023 International MOGAD Diagnostic criteria and meet all of the following requirements: i. a documented positive serum MOG Ab test using a cell-based assay (CBA); ii mRS Score ≥2; iii previously standardized use of corticosteroid, at least one immunosuppressant\u002Fmodulator, including CD20 monoclonal antibody with poorly-controlled symptoms or intolerance.\n3. All acute toxic reactions resolved to baseline or ≤ grade 1 assessed using NCI-CTCAE v5.0 except the ones adjudicated by the investigator to pose no risks on subjects.\n4. Enrolled subjects must have satisfactory organ function and laboratory findings as defined by the following:i. Blood tests: absolute neutrophil count ≥ 2×109\u002FL (or normal lower limit set by the central lab of the institution), platelets ≥ 100 × 109\u002FL, and hemoglobin ≥ 100 g\u002FL; ii. Liver function: total serum bilirubin, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must be ≤ 1.5x the institutional normal upper limit (ULN); iii. Kidney function: CrCl ≥ 60 ml\u002Fmin\u002F1.73m2 (according to the following Cockcroft-Gault formula); iv. Electrolytes: blood potassium ≥ 3.0 mmol\u002FL; blood calcium ≥ 2.0 mmol\u002FL, blood magnesium ≥ 0.5 mmol\u002FL; v. Coagulation function: fibrinogen ≥ 1.0 g\u002FL; APTT ≤ ULN + 10s; PT ≤ ULN + 3s.\n5. Blood oxygen saturation \\> 91% in resting state.\n6. Echocardiography suggests LVEF≥ 50%.\n7. Expected life expectancy ≥ 12 weeks as assessed by the investigator.\n8. After signing the informed consent form, subjects and their partners must be willing to use effective and reliable method of contraception, devices or medicines, within one year after CT103A cells infusion (excluding contraception safety periods).\n9. Subjects must provide written informed consent before the study begin.\n\nExclusion Criteria:\n\n1. Patients do not have adequate mononuclear cells without mobilization for CAR-T cell manufacturing.\n2. History of autoimmune hemolytic disease.\n3. History of solid organ transplantation.\n4. Patients were treated with alemtuzumab within 6 months prior to apheresis. Patients were treated with fludarabine or cladribine within 3 months prior to apheresis.\n5. Patients with Papovaviruses infection.\n6. Patients have been diagnosed with malignancies in the last 2 years prior to screening except for non-melanoma skin cancer, stage I cancers with complete resection and low risk of relapse, localized prostate cancer post-treatments, biopsy-confirmed in situ cervical cancer, or squamous epithelial lesion by PAP smear.\n7. Chronic and active hepatitis B (HBV), hepatitis C (HCV), Human Immunodeficiency Virus (HIV) infection, CMV or syphilis infections concurrently.\n8. MG crisis was not effectively controlled within 2 weeks before enrollment.\n9. Known history of primary immunodeficiency (innate or acquired).\n10. Patients with severe impaired cardiac function, including but not limited to the following: unstable angina, myocardial infarction (within 6 months before enrollment), congestive heart failure (≥Grade III by NYHA), severe ventricular arrhythmia.\n11. Cerebrovascular accidents, including transient ischemic attack or stroke history, occurred within 6 months before enrollment.\n12. Major operation or surgical treatment caused by any reason within 4 weeks before enrollment.\n13. Any serious and\u002For uncontrolled comorbidities which may interfere with the evaluation during the study in the opinion of the investigator\n14. Previous treatments: History of thymectomy within 12 months prior to CT103A infusion;\n15. History of psychoactive drug abuse and failed to withdraw, or have a history of psychiatric disorders.\n16. Prone to allergies or history of serious allergy.\n17. Pregnant or lactating women.\n18. Patients with other conditions adjudicated by the investigator as unsuitable for enrollment.\n\nCriteria for lymphodepletion and CAR-T cells infusion:\n\nBefore lymphocyte depletion and CAR-T cells infusion, patients are evaluated and those meeting the following criteria cannot be included:\n\n1. Blood tests: neutrophil count \\\u003C 2 × 109\u002FL, platelet count \\\u003C 50 × 10\\^9\u002FL;\n2. Oxygen inhalation is required to maintain blood oxygen saturation ≥ 91%;\n3. Patients have the following conditions, including but not limited to: new arrhythmia cannot be controlled by drugs; hypotension requiring pressor drugs; bacterial, fungal or viral infection requiring intravenous antibiotic treatment; creatinine clearance rate \\\u003C 50 ml\u002Fmin ;\n4. Patients require maintenance support treatment within one week to meet the criteria for lymphodepletion or CAR T cell infusion.\n5. Cell infusion is delayed \\> 7 days after lymphodepletion for any reason;\n6. Patients with other conditions adjudicated by the investigator as unsuitable for lymphodepletion or cell infusion.",{"count":293,"type":21},36,[163],"Antibody-mediated inflammatory diseases of the nervous system (also known as autoimmune diseases of the nervous system) are autoimmune diseases in which autoimmune cells and immune molecules attack the nervous system as the main pathogenic mechanism. In the immune response, pathogenic antibodies acting on autoantigens of the nervous system are collectively referred to as autoantibodies of the nervous system, and antibody-mediated inflammatory diseases of the nervous system can occur in the central nervous system, peripheral nervous system, and neuromuscular junctions, and muscles. In this study, we will recruit eight kinds of autoimmune diseases of nervous system including Neuromyelitis Optica Spectrum Disorder (NMOSD), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), idiopathic inflammatory myopathyand (IIM), multiple sclerosis (MS), autoimmune encephalitis (AE), Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) and POEMS Syndrome. B-cell maturation antigen (BCMA) is expressed on the surface of plasma cells, thus making it an ideal target for targeted therapies. Chimeric antigen receptor (CAR) T cells against BCMA offers another potential therapeutic option to eliminate plasma cells in patients with neurological autoimmune diseases driven by abnormal antibody who still suffer recurrent attacks from conventional treatments. In the current study, the safety and efficacy of a novel CAR-T cell therapy using CT103A cells, are evaluated in patients with relapsed\u002Frefractory antibody-mediated idiopathic inflammatory diseases.",[272,267,268,140,29,141,134,136,297,298],"Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)","POEMS Syndrome",[300,301,302,267],"Adoptive T Cell Therapy","Chimeric antigen receptor","B-cell maturation antigen (BCMA)","2024-10-27",{"date":305,"type":34},"2024-10-30",{"date":307,"type":34},"2020-09-22",{"date":309,"type":21},"2027-05-31",{"name":150,"class":151}]