[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neuromyelitis-optica-spectrum-disorder-nmosd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neuromyelitis-optica-spectrum-disorder-nmosd":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,85,122,149],{"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":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"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":20,"type":21},6,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31,32,33],"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":37,"type":38},"2026-05-12","ACTUAL",{"date":40,"type":38},"2026-04-01",{"date":42,"type":21},"2028-12-31",{"name":44,"class":45},"Tongji Hospital","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":67,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":46},"100599529","phase-1-phase-1-study-of-hbi0101-car-t-in-refractory-b-cell-autoimmune-diseases-100599529","NCT07085676","Phase 1 Study of HBI0101 CAR-T in Refractory B-Cell Autoimmune Diseases","A Phase 1 Dose Escalation and Safety Study of HBI0101 CART in B-cell Mediated Refractory Autoimmune Diseases","Inclusion Criteria:\n\n1. Age: 18\\~80 years old; for patients aged ≥ 75 years, geriatric assessment and endorsement are required;\n2. Diagnosis of B-cell mediated ARDs listed below:\n\n   SLE patients: individuals diagnosed with SLE according to American College of Rheumatology (ACR) and\u002For Systemic lupus international collaborating clinics (SLICC) classification criteria, who have severe and progressive disease course reflected by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score of 8 or more. Eligible patients must have failed to at least one of the conventional DMARDs (azathioprine, methotrexate, mycophenolate mofetil or cyclophosphamide), one of the calcineurin inhibitors (tacrolimus or cyclosporin) and one of the biologic agents (belimumab, rituximab or aniflorumab), each administered for a minimum of 3 months, or have a contraindication to, or have experienced toxicity from, any therapy within these categories. The failure is defined as:\n   * lack of response per SLEDAI-2k (\\\u003C4 points reduction from baseline) or no improvement in BILAG domains, or\n   * disease flare per SLEDAI-2k (≥4 points increase from baseline) or new BILAG A or ≥2 new BILAG B organ scores, or intolerance or discontinuation due to adverse effects.\n\n   SSc patients: Patients who were diagnosed with diffuse or limited cutaneous SSc according to the College of Rheumatology\u002FEuropean Alliance of Associations for Rheumatology (ACR-EULAR) classification criteria, with severe or rapidly progressive disease Eligible patients must meet any of the following criteria:\n   * Progression of skin thickening ≥ 12 over the past 6 months or Modified Rodnan skin score (mRSS) ≥15\n   * Any Medsger Disease Severity Score grade 3-4 in one major organ or grade ≥2 in two organs\n   * Progressive interstitial lung disease evidenced by HRCT or FVC \\\u003C80% or DLCO \\\u003C80%, or evidence of pulmonary function decline, defined as an absolute FVC decline of ≥ 10% , or FVC decline of 5% -9% combined with DLCO 15%.\n   * Other internal organ involvement.\n\n   Eligible patients must have failed to at least two state-of-the-art immunosuppressive therapies including MTX, MMF, cyclophosphamide, azathioprine, nintedanib, tocilizumab or rituximab; each therapy must have been administered for a minimum of 3 months, unless discontinued due to a contraindication or toxicity. The failure is defined as:\n   * lack of response in skin per mRSS (≤20% relative and ≤5 point absolute reduction from baseline) or no clinically meaningful improvement in FVC, DLCO, or other organ involved assessed by Medsger DSS, or\n   * disease flare in skin per mRSS (increase in mRSS ≥20% and ≥5 points from baseline) or decline in FVC ≥10% predicted or in DLCO ≥15% predicted from baseline, other major SSc complication, or\n   * intolerance or discontinuation due to adverse effects\n\n   IIM, including dermatomyositis, anti-synthetase syndrome, immune mediated necrotizing myopathy, and polymyositis: patients must be diagnosed with IIM according to the 2017 ACR\u002FEULAR Classification Criteria for idiopathic inflammatory myopathies.\n\n   Eligible patients must have active disease, defined by at least one of the following:\n   * CPK ≥4xULN\n   * Loss of muscle strength in the weakest muscle group for less than 80% per MMT8\n   * Evidence on MRI of active myositis within last 6 months\n   * Evidence on EMG of active myositis within last 6 months\n   * Muscle biopsy evidence of active myositis within last 6 months\n\n   Only patients with refractory disease will be recruited, defined as previous failure to (1) at least two of five non-glucocorticoids immunosuppressive therapies and (2) either rituximab or IVIG, each administered for a minimum of 3 months, or have a contraindication to, or have experienced toxicity from, any therapy within these categories. The five non-glucocorticoids therapies considered are azathioprine, MTX, MMF, IVIG, and rituximab The failure is defined as:\n   * lack of response in muscle strength per MMT-8 or CPK (\\\u003C20% relative improvement) or per MRI or\n   * disease flare in muscle strength per MMT-8 (≥30% decline) or CPK (≥30% rise) or objective worsening of other organ involvement per Myositis Disease Activity Assessment Tool or\n   * intolerance or discontinuation due to adverse effects\n\n   RA patients: Seropositive RA patients (positive for anti-cyclic citrullinated peptide and rheumatoid factor), diagnosed according to the 2010 ACR\u002FEULAR classification criteria.\n\n   Eligible patients must exhibit high disease activity (DAS28CRP ≥5.1), and be resistant to at least four conventional synthetic and biologic disease-modifying antirheumatic drugs (DMARD) groups.\n\n   Each patient must have previously received at least one medication from each of the mentioned groups, including\n   * JAK-STAT inhibitors\n   * Anti-TNF agents\n   * Anti-IL6 drugs\n   * Anti-CTLA4-Ig treatments, each administered for a minimum of 3 months, or have a contraindication to, or have experienced toxicity from, any therapy within these categories\n\n   Drug resistance is defined as:\n   * Inadequate clinical response measured by composite score DAS28CRP (\\> 3.6) or failure to reach ACR20 or\n   * Disease progression measured by DAS28CRP (≥20% increase) or radiographic progression or\n   * Intolerance or discontinuation due to adverse effects\n\n   NMOSD: Patients must be diagnosis of AQP4-IgG-positive NMOSD based on the 2015 International Panel for NMOSD Diagnosis (IPND) criteria (Wingerchuk et al., 2015).\n\n   Eligible patients must have experienced at least two relapses in the past 24 months, with at least one occurring in the preceding 12 months before screening Each patients must have previously received with inadequate disease control (one or more clinical attacks, with new MRI activity, despite adequate treatment dosing) at least one immunosuppressant for at least 6 months (azathioprine or mycophenolate mofetil) and\u002For Rituximab for at least 3 months and\u002For a targeted therapy (eculizumab, inebilizumab, or satralizumab) or must have a contraindication to such treatment.\n\n   MS patients: must have confirmed history of diagnosis of primary progressive or secondary progressive MS .\n\n   Eligible patients must have: Expanded Disability Status Scale (EDSS) score between 3.0 and 8.5 and evidence of disease activity, defined by either clinical progression and\u002For radiological finding on MRI, such as new, enhancing or enlarging lesions in the last 12 months.\n\n   Eligible patient must have previously received at least one high efficacy drug and have been offered standard treatments and have experienced disease progression or lack of efficacy despite at least six months of treatment. These will include clinical activity (new relapse\\[s\\]), radiological activity (new or enlarging T2 lesions and\u002For gadolinium-enhancing lesions on MRI), or confirmed disability progression (an increase in least 1 point on the EDSS sustained for ≥6 months).\n\n   Eligible patient must have history of treatment with anti-CD20 mAb with continuing evidence of worsening physical disability over a period of ≥6 months, with documented clinical disability progression within the year prior to inclusion, irrespective to concurrent MRI activity.\n\n   MG patients must meet all the following criteria:\n\n   \\- Confirmed diagnosis of generalized MG, supported by positive autoantibodies (anti-AChR, anti-MuSK).\n\n   Disease Severity:\n   * Myasthenia Gravis Activities of Daily Living (MG-ADL) score of ≥6, with ocular symptoms constituting less than 50% of the total score.\n   * Myasthenia Gravis Foundation of America (MGFA) clinical classification of II to IV.\n\n   Eligible patients must have Refractory Status and meet at least one of the following criteria:\n   * No improvement or worsening myasthenic symptoms, with failure to achieve minimal manifestation status or meaningful improvement in MGFA class or MG-ADL score, or recurrent myasthenic exacerbations despite adequate immunosuppressive or immunomodulatory therapy for at least 6 months for all therapies and 3 months for B cell depletion therapy\n   * Improvement in Post-Intervention Status (PIS), but with an MG-ADL score ≥6 persisting for at least 4 months.\n   * Remission or improvement in PIS, but with ≥1 episode of disease exacerbation (MG-ADL ≥6) per year during tapering of immunotherapy medications.\n   * After experiencing a myasthenic crisis, patients who undergo multiple immunotherapies (e.g., intravenous immunoglobulin, plasma exchange, high-dose intravenous methylprednisolone), thymectomy, and active infection control but still cannot be weaned off the ventilator due to MG-induced respiratory muscle weakness for more than 14 days.\n\n   Each patient must receive stable doses of medication prior to enrollment.\n\n   Refractory APLA patients: must have confirmed history of APLA, based on Sydney 2006 or ACR\u002FEULAR 2023 criteria\n\n   \\- Eligible patients must have medium to high-titer antiphospholipid antibodies, documented repeatedly (≥2 tests spanning 12 weeks) Eligible patients must have refractory disease: persistent or recurrent arterial thrombosis, venous thrombosis or diffuse alveolar hemorrhage despite conventional therapy with stable treatment with vitamin K antagonist anticoagulation (maintained at therapeutic stable dose keeping INR consistently within target range) and immunosuppression treatment including glucocorticoid, rituximab and Plaquenil\n3. AST\u002FALT below 5 times the upper limit of normal, blood bilirubin below 3 times the upper limit of normal ;\n4. Cardiopulmonary function is basically normal, echocardiography indicates that the ejection fraction is \\>45%, normal to mild pulmonary hypertension, and the oxygen saturation is above 93% in the resting state without oxygen;\n5. No obvious active infection;\n6. There are no contraindications for blood collection;\n7. Women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months, must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study;\n8. Voluntary participation and informed consent signed by the patient or his\u002Fher legal\u002Fauthorized representative.\n9. Ability and willingness to adhere to the study visit schedule and all protocol requirements\n\nExclusion Criteria\n\n1. CNS disease- History of CNS or spinal cord tumor, metabolic or infectious cause of myelopathy, genetically inherited progressive CNS disorder, sarcoidosis, non-autoimmune progressive neurologic condition or PML\n2. Abnormal liver function: aspartate transaminase (AST) or alanine transaminase (ALT) or glutamyl transpeptidase (GGT) or alkaline phosphatase (ALP) detection value is greater than 5 times the upper limit of normal (ULN); or total bilirubin test value greater than 3 times the upper limit of normal (ULN); Exceptional: liver function disturbance due to myositis.\n3. Cardiovascular disease: Unstable angina or myocardial infarction or coronary artery bypass graft (CABG) within 6 months prior to leukapheresis\u002F moderate- severe pulmonary hypertension\u002F severe arrhythmia (ventricular tachycardia, ventricular fibrillation, high grade ventricular block) in the past 6 months; New York heart function class (NYHA) class III- Level IV or LVEF\\\u003C45%.\n4. Lung disease: patients with chronic lung disease with any of the following: \\* Oxygen saturation (SpO2) \\\u003C 90% on room air \\* FVC≤45% of predicted or DLCO≤40% of predicted at screening. \\* Evidence of pulmonary hypertension as defined as estimated RVSP\\> 50 mmHg.\n5. Muscle disease: evidence of any of the following: \\* Severe proximal muscle atrophy of upper or lower extremity on MRI or clinical examination. \\*Finding of muscular inflammation or myopathy other than the indication, such as inclusion body myositis (IBM), or cancer-associated myositis (myositis diagnosed within 2 years of cancer).\n6. Other uncontrolled diseases: acute diseases (such as acute pneumonia or other infection, pulmonary embolism, diabetic ketoacidosis, acute pancreatitis, etc.) that are clinically unstable or have not been effectively controlled and are not related to indicated autoimmune diseases which in the judgment of the investigator may confound study results or place subjects at undue risk.\n7. Biologics therapy: Received rituximab within 4 months of expected CAR T treatment: No plasma exchange or immunoglobulin treatment within 4 weeks prior to screening. MS patients: No high dose corticosteroid treatment in the 30 days prior to enrollment; see also section 9.1 for the list of restrictions.\n8. Participated in any clinical study within 3 months prior to enrollment, or participate in other clinical investigations during the study period.\n9. Previous or concurrent malignancy with the following exceptions: Adequately treated basal cell or squamous cell carcinoma, in situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to screening. A primary malignancy which has been completely resected, or treated, and is in complete remission for at least 5 years prior to screening.\n10. Transplantation: History of vital organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell\u002For bone marrow transplantation.\n11. Disease-specific criteria: MS\u002FNMO patients: No disease relapse in the 30 days prior to enrollment\n12. Known HIV positive status.\n13. Active hepatitis B or C infection.\n14. Active CMV infection\n15. Pregnant or lactating women.\n16. Inability to understand or follow the research protocol subject requirements.\n17. Have any other clinically significant disease history or current disease that, in the judgment of the research physician, may pose a risk to the safety of the subjects, or interfere with the completion of the research procedure and the evaluation of safety and efficacy","80 Years",{"count":56,"type":21},120,[24],"A Phase 1 study of HBI0101 BCMA-CART in B-Cell Mediated Autoimmune Rheumatic Diseases. The goal of the study is evaluation of safety and identification of the maximum HBI0101 CART dose that may be administered safely to patients with B-cell mediated autoimmune disease.",[60,61,62,63,64,65,28,31,66],"Systemic Sclerosis (SSc)","Idiopathic Inflammatory Myopathy (IIM)","Rheumatoid Arthritis (RA)","Systemic Lupus Erythematosus (SLE)","Multiple Sclerosis (MS) Primary Progressive","Multiple Sclerosis (MS) Secondary Progressive","Antiphospholipid Antibody Syndrome",[68,63,69,70,71,72,73,74,28,31,75],"B-cell mediated autoimmune rheumatic diseases","Systemic sclerosis (SSC)","Idiopathic inflammatory myopathy (IIM)","Rheumatoid arthritis (RA)","B-cell maturation antigen (BCMA)","Autologous CAR-T","Multiple sclerosis (MS) Primary and Secondary progressive","refractory antiphospholipid antibody syndrome","2026-04-29",{"date":78,"type":38},"2026-05-06",{"date":80,"type":38},"2024-09-01",{"date":82,"type":21},"2030-11-01",{"name":84,"class":45},"Polina Stepensky",{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":92,"minAge":4,"maxAge":4,"enrollmentInfo":93,"targetDuration":95,"studyType":96,"phases":4,"briefSummary":97,"conditions":98,"keywords":104,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":121},"100540115","study-of-ultomiris-ravulizumab-safety-in-pregnancy-100540115","NCT06312644","Study of Ultomiris® (Ravulizumab) Safety in Pregnancy","Observational Study of Ultomiris® (Ravulizumab) Safety in Pregnancy","Inclusion Criteria:\n\n* Female participant must have a medically confirmed qualifying pregnancy (prospectively or retrospectively identified).\n* Participant informed consent (written or e-consent per local regulations or ethics committee requirements) must be obtained prior to the participant's enrollment. If the participant is a minor, consent must be obtained from the parent or legal guardian, with assent from the minor (as locally appropriate).\n* Willing to provide contact information for the participant.\n* Willing to authorize HCP(s) to release maternal and infant medical information to the study, upon request, if applicable to current local regulations.\n* Diagnosed with an indication for which Ultomiris is approved, based on HCP or medical records.\n* Exposed to Ultomiris at any point during the defined exposure window based on HCP or medical record documentation. (If exact exposure dates are unknown, the reporter must be able to specify or estimate trimester or timing of exposure \\[prior to conception as LMP+14 days, or during breastfeeding\\].)\n* Use of Ultomiris per local product information (i.e., United States Prescribing Information \\[USPI\\] or summary of product characteristics \\[SmPC\\])\n\nExclusion Criteria:\n\n* Participants who are unable to provide consent or assent (as locally appropriate) (e.g., diagnosed with severe psychiatric conditions or severe intellectual disabilities) will be excluded from this study","FEMALE",{"count":94,"type":21},75,"21 Months","OBSERVATIONAL","The primary objective of this study is to describe the frequency and characteristics of pregnancy outcomes and maternal complications among participants exposed to Ultomiris and to describe the frequency and characteristics of selected fetal\u002Fneonatal\u002Finfant outcomes in utero, at birth, and through 1 year of age after exposure in utero or via breastmilk.",[99,100,101,102,103,28],"Ultomiris-exposed Pregnant\u002F Postpartum","Pregnancy","Paroxysmal Nocturnal Hemoglobinuria (PNH)","Atypical Hemolytic Uremic Syndrome (aHUS)","Generalized Myasthenia Gravis (gMG)",[105,106,107,108,109,110],"Ultomiris","pregnancy","PNH","aHUS","gMG","NMOSD","2026-04-15",{"date":113,"type":38},"2026-04-16",{"date":115,"type":38},"2024-12-16",{"date":117,"type":21},"2034-07-11",{"name":119,"class":120},"Alexion Pharmaceuticals, Inc.","INDUSTRY",7,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":126,"acronym":110,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":130,"briefSummary":132,"conditions":133,"keywords":134,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":46},"100576086","impact-of-a-structured-wellness-behavioral-intervention-on-quality-of-life-in-nmosd-100576086","NCT06780709","Impact of a Structured Wellness Behavioral Intervention on Quality of Life in NMOSD","Inclusion criteria:\n\n* Adults (age ≥18) with NMOSD diagnosed with 2015 NMOSD clinical criteria.\n* All EDSS scores will be considered in order to make the intervention accessible to all patients regardless of disability.\n* All patients regardless of treatment type will be considered.\n\nExclusion criteria:\n\n* Age\\\u003C18\n* Inability to voluntarily provide consent for study participation\n* Inability to participate in study evaluation and\u002For endpoint measures, or participation in another concurrent randomized controlled trial or wellness based intervention.\n* Any patients with a relapse within 30 days of randomization or any patients with medical restrictions on physical activity will be excluded.\n* Any patients who begin stimulants and\u002For dalfampridine between enrollment and randomization will be excluded.",{"count":129,"type":21},20,[131],"NA","This project aims to study whether a structured wellness program intervention can improve quality of life among people living with Neuromyelitis Optica Spectrum Disorder (NMOSD). This pilot will test a multi-modal wellness program tailored to NMOSD patients that includes services from physical therapists, dietitians, social workers, nurse practitioners and cognitive therapists. The trial will be designed as a randomized controlled trial, randomizing patients to immediately starting the program as well as a 6 month delayed start. The intervention would leverage an existing clinical comprehensive MS wellness program at the Corinne Dickinson for Multiple Sclerosis (MS) at Mount Sinai Medical Center. The primary endpoint of this study would be evaluating quality of life, as assessed by MS-Quality of Life -54.",[28],[110,135,136,137,138,139],"Wellness","Diet","Physical Therapy","Social Work","Comprehensive","2025-04-15",{"date":142,"type":38},"2025-04-17",{"date":144,"type":38},"2025-01-21",{"date":146,"type":21},"2028-01",{"name":148,"class":45},"Icahn School of Medicine at Mount Sinai",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":159,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":163,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":4},"100558903","phase-1-a-study-to-evaluate-imc-002-in-neuromyelitis-optica-spectrum-disorder-nmosd-patients-100558903","NCT06557174","A Study to Evaluate IMC-002 in Neuromyelitis Optica Spectrum Disorder (NMOSD) Patients","A Phase Ib\u002FIII Multi-center, Randomized and Positive Control Study to Evaluate IMC-002 Safety and Efficacy in in Neuromyelitis Optica Spectrum Disorder (NMOSD) Patients","Inclusion Criteria:\n\n* Age 18 to 70 years, inclusive, at the time of informed consent\n* Have a diagnosis of AQP4 antibody seropositive NMOSD according to the International Panel for NMO Diagnosis (IPND) criteria\n* Confirmation of NMOSD diagnosis with AQP4+ antibodies\n* The EDSS score should be ≤7.0\n* Have clinical evidence of at least 1 documented attack or relapse (including first attack) in the last 2 years prior to screening\n\nExclusion Criteria:\n\n* Have received rituximab or other anti-CD20 drugs treatment within 6 months\n* Have been used any monoclonal antibodies or research drugs for immunomodulatory effects within 3 months or within 5 half-life periods of the drug.\n* Females who are pregnant or lactating.\n* Have active infection at screening, or recent serious infection (i.e., requiring intravenous antimicrobial therapy or hospitalization) ; history of or existing infection of human immunodeficiency virus(HIV), hepatitis C virus (HCV), or Mycobacterium tuberculosis. Patients must have negative test results for HCV antibody, HIV 1 and HIV 2 antibodies, and a mycobacterium tuberculosis test (test method to be determined).","70 Years",{"count":158,"type":21},116,[24,160],"PHASE2","The purpose of this study is to evaluate the efficacy and safety of IMC-002 in the treatment of NMOSD.",[28],"NOT_YET_RECRUITING","2024-08-15",{"date":166,"type":38},"2024-08-16",{"date":168,"type":21},"2024-10-10",{"date":170,"type":21},"2026-07-10",{"name":172,"class":45},"ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd."]