[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"generalized-myasthenia-gravis-gmg\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:generalized-myasthenia-gravis-gmg":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,39,64,82,103,137,163,185],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100611953","epidemiological-study-of-treatment-approaches-in-achr-antibody-positive-generalized-myasthenia-gravis-in-russia-100611953",false,"NCT07247279","Epidemiological Study of Treatment Approaches in AChR-Antibody Positive Generalized Myasthenia Gravis in Russia","A Multicenter Non Interventional Single Arm Retrospective-prospective Observational Study in Therapeutic Approaches in AChR-Antibody Positive Generalized Myasthenia Gravis (gMG) in Real Clinical Practice in Russia","Inclusion Criteria:\n\n1. Adults (≥18 years) diagnosed with generalized MG positive for acetylcholine receptor (AChR) antibodies.\n2. Provision of signed and dated written informed consent.\n\nExclusion Criteria:\n\n1. Participants currently enrolled in clinical studies for treatment of gMG.\n2. Ocular MG only.","ALL","18 Years",{"count":19,"type":20},450,"ESTIMATED","OBSERVATIONAL","This is a multicenter, non-interventional, retrospective-prospective, single-arm observational study designed to describe real-world treatment approaches and clinical outcomes among adults with acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (gMG) in routine clinical practice in Russia.",[24,25],"Rare Diseases","Generalized Myasthenia Gravis (gMG)","RECRUITING","2026-06-12",{"date":29,"type":30},"2026-06-15","ACTUAL",{"date":32,"type":30},"2025-12-23",{"date":34,"type":20},"2029-12-31",{"name":36,"class":37},"AstraZeneca","INDUSTRY",6,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":48,"conditions":49,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":63},"100615558","adapt-forward---master-protocol-of-a-platform-study-to-evaluate-the-safety-and-efficacy-of-multiple-regimens-in-participants-with-myasthenia-gravis-100615558","NCT07294170","ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis","A Master Protocol for an Exploratory, Phase 2a, Proof-of-Concept Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis","Inclusion Criteria:\n\n* Is at least 18 years of age and the local legal age of consent for clinical studies\n* Has been diagnosed with MG with consistent clinical features per the investigator's clinical judgment\n* If receiving MG therapy, including nonsteroidal immunosuppressive drugs (NSIDs), corticosteroids, or acetylcholinesterase (AChE) inhibitors either in combination or alone, the participant should receive a stable dosage before master protocol screening\n\nExclusion Criteria:\n\n* Known autoimmune disease or any medical condition other than the indication under study that would interfere with an accurate assessment of clinical symptoms of MG or puts the participant at undue risk\n* Is MGFA (Myasthenia Gravis Foundation of America) Class V",{"count":47,"type":20},70,"ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis. The goal is to find the best therapeutic approach to reduce patients' side effects and improve their quality of life.",[50,51,52,53,25,54],"Myasthenia Gravis","MG","gMG","Generalized Myasthenia Gravis","AChR-Ab Seropositive Generalized Myasthenia Gravis","2026-06-11",{"date":27,"type":30},{"date":58,"type":30},"2025-12-19",{"date":60,"type":20},"2028-03-07",{"name":62,"class":37},"argenx",18,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":79,"leadSponsor":80,"locationsCount":81},"100614809","phase-2-adapt-forward-1---isa1---a-study-to-evaluate-empasiprubart-iv-as-add-on-therapy-to-efgartigimod-iv-in-participants-with-achr-ab-seropositive-generalized-myasthenia-gravis-with-a-partial-clinical-response-to-efgartigimod-100614809","NCT07284420","ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod","An ISA to Master Protocol ARGX-999-2-MG-2000 for an Exploratory, Phase 2a, Proof-of-Concept Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV as Add-On Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod","Inclusion Criteria:\n\n* Is seropositive for anti-acetylcholine receptor antibodies (AChR-Ab)\n* Has confirmed diagnosis of gMG and is Myasthenia Gravis Foundation of America (MGFA) Class II, III, IVa, or IVb\n* Has documented immunization against encapsulated bacterial pathogens (Neisseria meningitidis and Streptococcus pneumoniae) within 5 years of ISA screening or is willing to receive immunization at least 14 days before the first study drug administration\n\nExclusion Criteria:\n\n* Clinical diagnosis of systemic lupus erythematosus (SLE)\n* Any known complement deficiency\n* Current administration of a complement inhibitor or received zilucoplan or eculizumab \\\u003C2 months or ravulizumab \\\u003C6 months before the first study drug administration\n* Patients proven to be refractory to efgartigimod (ie, not achieving a clinically meaningful improvement in total Myasthenia Gravis Activities of Daily Living (MG-ADL) score defined as an improvement of ≥2 points)",{"count":47,"type":20},"INTERVENTIONAL",[74],"PHASE2","This study is part of the ADAPT Forward platform study (NCT07294170). ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis. The goal is to find the best therapeutic approach to reduce patients' side effects and improve their quality of life.\n\nThe aim of this ISA1 is to evaluate the safety and therapeutic relevance of empasiprubart as add-on therapy to efgartigimod in participants with AChR-Ab seropositive generalized myasthenia gravis.\n\nThe ADAPT Forward master protocol is registered on https:\u002F\u002Fclinicaltrials.gov\u002Fstudy\u002FNCT07294170",[54,50,51,52,53,25],{"date":27,"type":30},{"date":58,"type":30},{"date":60,"type":20},{"name":62,"class":37},15,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100639176","a-study-to-evaluate-the-impact-of-efgartigimod-on-overall-disease-experience-of-people-suffering-from-generalized-myasthenia-gravis-gmg-in-italy-100639176","NCT07595653","A Study to Evaluate the Impact of Efgartigimod on Overall Disease Experience of People Suffering From Generalized Myasthenia Gravis (gMG) in Italy","Non-interventional, Longitudinal Hybrid Data Sources Study to Evaluate the Impact of Efgartigimod on Overall Disease Experience of People Suffering From Generalized Myasthenia Gravis (gMG) in Italy","POEMA","Inclusion Criteria:\n\n* At least 18 years old at signing of informed Consent Form (ICF) and privacy form (PF)\n* Documented diagnosis of gMG\n* AChR-antibody positive\n* The treating physician has decided to initiate efgartigimod alfa as part of routine clinical care and in accordance with product labelling, independently from the study\n\nExclusion Criteria:\n\n* Hypersensitivity to the active substance or to any of the excipients listed: sodium dihydrogen phosphate, monohydrate; disodium hydrogen phosphate, anhydrous; arginine hydrochloride; polysorbate 80, hyaluronidase, histidine, histidine hydrochloride monohydrate, methionine, polysorbate 20, sucrose.\n* Current or planned participation in an interventional clinical trial.",{"count":91,"type":20},100,"This study aims to generate real world evidence (RWE) from Italian clinical practice on the impact of efgartigimod alfa in gMG patients encompassing clinical outcomes and patient reported experiences.\n\nThe study population will consist in adult patients with a documented diagnosis of gMG who are AChR-antibody positive and for whom the decision of treatment with efgartigimod alfa for gMG has been made independently of study participation as part of routine clinical care.\n\nThe total study duration will be up to 23 months",[25,52],"2026-05-12",{"date":96,"type":30},"2026-05-19",{"date":98,"type":30},"2026-02-25",{"date":100,"type":20},"2028-07",{"name":62,"class":37},30,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":110,"minAge":4,"maxAge":4,"enrollmentInfo":111,"targetDuration":113,"studyType":21,"phases":4,"briefSummary":114,"conditions":115,"keywords":121,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":136},"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":112,"type":20},75,"21 Months","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.",[116,117,118,119,25,120],"Ultomiris-exposed Pregnant\u002F Postpartum","Pregnancy","Paroxysmal Nocturnal Hemoglobinuria (PNH)","Atypical Hemolytic Uremic Syndrome (aHUS)","Neuromyelitis Optica Spectrum Disorder (NMOSD)",[122,123,124,125,52,126],"Ultomiris","pregnancy","PNH","aHUS","NMOSD","2026-04-15",{"date":129,"type":30},"2026-04-16",{"date":131,"type":30},"2024-12-16",{"date":133,"type":20},"2034-07-11",{"name":135,"class":37},"Alexion Pharmaceuticals, Inc.",7,{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":72,"phases":145,"briefSummary":147,"conditions":148,"keywords":149,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":162},"100609543","phase-3-zilucoplan-for-severe-gmg-exacerbations-100609543","NCT07215949","Zilucoplan for Severe gMG Exacerbations","Zilucoplan Treatment of Severe MG Exacerbations Leading to Hospitalization of Participants With Acetylcholine Receptor Antibody Positive gMG","Inclusion Criteria:\n\n* Patient determined to have severe MG exacerbation (e.g. bulbar and\u002For respiratory symptoms requiring hospitalization, neck extension weakness)\n* MGFA class II - IVb\n* Male or female aged ≥18\n* MG-ADL ≥6 in non-ocular domains\n* Serology - AChR antibody positive (or historically available data)\n* If female of child-bearing potential (i.e., not surgically sterile or post-menopausal defined as age \\> 51 years without menses for ≥ 2 years), negative serum pregnancy test at screening\n* Women of child-bearing potential or men with sexual partners of childbearing potential must be willing to use an acceptable method of birth control for the duration of the study and for 40 days after the last dose of study drug therapy. Acceptable methods of birth control include abstinence, oral contraceptives, the contraceptive patch, intra-uterine device, the contraceptive ring, and or barrier contraception such as condoms with spermicide.\n* Completed or updated meningococcal vaccination or initiated meningococcal vaccination with appropriate antibiotic prophylaxis according to current USPI and ACIP guidelines\n\nExclusion Criteria:\n\n* History of meningococcal disease\n* Participants requiring intubation prior to study start.\n* Recent significant infections which could have caused exacerbation e.g. sepsis and wound infections\n* Pregnancy or lactating\n* Recent surgery (\\\u003C4 weeks). Minor procedures\u002Fsurgeries allowed at the discretion of the site principal investigator\n* Current use or known failure of C5 inhibitors in the previous 3 months\n* Initiation of plasma exchange or IVIG in the past 4 weeks\n* Participation in concurrent clinical trial with a therapeutic medication\n* Rituximab use in the previous 9 months\n* Any clinically significant condition or illness, which, in the opinion of the PI, would pose a risk to the subject or might confound the study",{"count":81,"type":20},[146],"PHASE3","This is an open-label, multicenter, interventional phase 3b study in participants with AChR+ gMG and severe exacerbation that require hospitalization. Patients will receive subcutaneous zilucoplan injections daily for 12 weeks. Participation in the study will last for approximately 18 weeks.",[25],[51,150,151],"exacerbation","zilucoplan","2026-02-20",{"date":154,"type":30},"2026-02-23",{"date":156,"type":30},"2026-01-20",{"date":158,"type":20},"2028-04-01",{"name":160,"class":161},"Miriam Freimer","OTHER",1,{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":170,"enrollmentInfo":171,"targetDuration":4,"studyType":72,"phases":172,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":162},"100597423","early-phase-1-gc012f-injection-in-the-treatment-of-refractory-generalized-myasthenia-gravis24103-100597423","NCT07058298","GC012F Injection in the Treatment of Refractory Generalized Myasthenia Gravis(24103)","An Early Exploratory Clinical Study of GC012F Injection in the Treatment of Refractory Generalized Myasthenia Gravis","Inclusion Criteria:\n\n* To be enrolled, subjects must meet all of the following criteria:\n\n  1. Subjects or their legal representatives voluntarily sign a written informed consent and are willing and able to comply with the procedures of the study;\n  2. Subjects aged 18-75 years old (both inclusive), male or female;\n  3. Subjects with confirmed refractory gMG of classes IIa - IVb by MGFA clinical classification (including classes IIa, IIb, IIIa, IIIb, IVa and IVb) at screening;\n  4. Subjects with the Myasthenia Gravis - Activities of Daily Living (MG-ADL) score of ≥6, the proportion of ocular symptoms of \\\u003C50% of the total score, and the Quantitative Myasthenia Gravis (QMG) score of ≥11;\n  5. Subjects with poor response and\u002For who do not respond to the conventional therapies, that means subjects who are still at risk of relapse or exacerbation after conventional therapies with hormones, immunosuppressants (e.g., azathioprine, mycophenolate mofetil, tacrolimus, cyclosporin A, cyclophosphamide, methotrexate, etc.), or biological agents (e.g., rituximab);\n  6. For patients who are taking corticosteroids, the dose of prednisone should not exceed 30 mg\u002Fday (or an equivalent dose of other corticosteroids), and the dose must be stable for at least 4 weeks before infusion;\n  7. The laboratory test results during the screening period meet the following criteria:\n\n     1. Neutrophil count ≥ 1.0×10\\^9\u002FL; Hemoglobin ≥ 8.0 g\u002FdL; Platelet count≥50×10\\^9\u002FL;\n     2. Alanine aminotransferase ≤ 3× upper limit of normal (ULN); Aspartate aminotransferase ≤ 3×ULN; total bilirubin (TBIL) \\\u003C 2× ULN (for subjects with Gilbert's syndrome), direct bilirubin (DBIL)) ≤ 1.5×ULN\n     3. Creatinine clearance (19.3 Appendix 3) ≥ 30 mL\u002Fmin;\n     4. Activated partial thromboplastin time (APTT) ≤ 1.5×ULN, prothrombin time (PT)≤ 1.5×ULN;\n     5. Subject's left ventricular ejection fraction (LVEF) is ≥ 50% by echocardiography, with no evidence of pericardial effusion as determined;\n  8. Female subjects of child-bearing age must:\n\n     1. At screening, a negative serum β human chorionic gonadotropin β-hCG pregnancy test result confirmed by the investigator;\n     2. Who agree to avoid breastfeeding during the study period until at least 1 year after the infusion of GC012F Injection or until two consecutive flow cytometry tests show the absence of CAR-T cells (whichever occurs later).\n  9. Male subjects with sexual partners and female subjects of potential child-bearing age shall agree to take effective contraceptive measures (e.g., oral contraceptive pills, intrauterine device or condom) from the screening period until at least 2 years after the infusion of GC012F Injection or until two consecutive flow cytometry tests show the absence of CAR-T cells (whichever occurs later). Male subjects must agree to use condoms during sexual contact with pregnant women or females of child-bearing age within at least 2 years after the infusion of GC012F Injection, even if a successful vasectomy has been performed;\n  10. Subjects for whom venous access available for blood collection can be established, and with no contraindications to leukocyte collection.\n\nExclusion Criteria:\n\n* Participants who meet any of the following criteria are not included in the study:\n\n  1. Have a history of severe hypersensitivity or allergy;\n  2. Contraindications or hypersensitivity to fludarabine, cyclophosphamide and any component of the test drug;\n  3. Subjects who have received intravenous immunoglobulin or plasma exchange therapy or immunoadsorption therapy within 4 weeks prior to infusion;\n  4. Received CD20-targeted drugs within 6 months prior to apheresis;\n  5. Received Tacrolimus, Cyclosporine, Azathioprine, Mycophenol Mofetil within 1 week before apheresis;\n  6. Treatment with neonatal Fc receptor (FcRn) antagonists within 1 week prior to apheresis;\n  7. Patients who have received complement inhibitors (e.g., eculizumab, etc.) within 1 weeks before apheresis ;\n  8. Subjects with any of the following heart diseases:\n\n     1. Class III or Class IV congestive heart failure based on New York Heart Association (NYHA) Functional Classification;\n     2. Unstable angina, myocardial infarction or coronary artery bypass grafting (CABG) within 6 months prior to screening;\n     3. Clinically significant ventricular arrhythmia or a history of unexplained syncope not due to vasovagal reaction or dehydration; or a QTc interval \\>480 ms at screening;\n     4. Has a history of severe non-ischemic cardiomyopathy;\n     5. Severe cardiovascular abnormalities (such as brain natriuretic peptide (BNP)\u002Ftroponin and other indices) and the investigator judges that such subjects are not eligible for enrollment.\n  9. Subjects with other uncontrolled malignancies. The following conditions will be excluded: early-stage tumors that have been treated by radical surgery (carcinoma in situ or grade 1 tumors, or non-ulcerative primary melanoma with a depth of \\\u003C1 mm and with no involvement of lymph nodes), basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in situ, or breast cancer in situ that has been treated by potential radical treatment;\n  10. Serious underlying medical conditions, such as:\n\n      1. Viral, bacterial, fungal, or other infections that are uncontrollable or requiring systemic intravenous therapy (including tuberculosis infection with clear evidence of disease activity) as demonstrated by evidence;\n      2. Dementia or mental status changes as demonstrated by significant clinical evidence;\n      3. History of any central nervous system (CNS) or neurodegenerative diseases, (e.g., Epilepsy, Convulsion, Paralysis, Aphasia, Stroke, Severe brain injury, Dementia, Parkinson's disease, Mental Illness).\n  11. Positive result for any of the following tests:\n\n      1. Positive test result of human immunodeficiency virus (HIV) antibody;\n      2. Positive test result of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) (HBV DNA copy number will be detected for HBcAb- or HBsAb-positive patients. If the copy number is lower than the lower limit of detection, patients can be enrolled under the premise of standardized antiviral therapy);\n      3. Positive test result of hepatitis C virus (HCV) antibody with the copy number of HCV RNA higher than the lower limit of detection; or with known history of hepatitis C without completion of antiviral therapy for ≥24 weeks;\n      4. Positive test result of Syphilis antibody.\n  12. Prior treatment with a CAR-T product for any target;\n  13. Previous organ or allogeneic bone marrow transplantation;\n  14. Subjects who have undergone surgery within 2 weeks prior to lymphodepletion pretreatment or plan to undergo surgery during the study (except subjects who schedule for local anesthesia surgery, but the surgery cannot be performed within 2 weeks after infusion);\n  15. Received live attenuated vaccine within 4 weeks prior to lymphodepletion pretreatment;\n  16. Subjects who have received study drugs in other clinical trials within 4 weeks prior to signing the informed consent form, or whose ICF signing date is within 5 half-lives of the last dose they had taken in other clinical trial (whichever is longer);\n  17. Pregnant females or lactating females who do not agree to give up breastfeeding, during the period of participation in this study or men with a family plan within 1 year of receiving study treatment and females;\n  18. Subjects with suicidal intentions at present based on the Columbia-Suicide Severity Rating Scale (C-SSRS), i.e., the answer to Question 4 (Active Suicidal Ideation with Some Intent to Act, without Specific Plan) or Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on \"Suicide\" in the C-SSRS is \"Yes\", or who have a history of suicidal behavior at present;\n  19. According to the researcher's judgment, there are circumstances that may prevent the subject from participating in the full trial, confuse the trial results, or participation in this study is not in the best interests of subjects.","75 Years",{"count":38,"type":20},[173],"EARLY_PHASE1","This is a single-arm, open-label and early exploratory clinical study, with the purpose to study the safety, tolerability and initial clinical efficacy of GC012F Injection in the treatment of refractory GMG and to evaluate the PK, PD characteristics and immunogenicity in subjects with refractory GMG infused with GC012F Injection.",[25],"2025-09-05",{"date":178,"type":30},"2025-09-08",{"date":180,"type":30},"2025-07-15",{"date":182,"type":20},"2027-09-10",{"name":184,"class":161},"Daishi Tian",{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":168,"officialTitle":168,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":170,"enrollmentInfo":191,"targetDuration":4,"studyType":72,"phases":192,"briefSummary":174,"conditions":194,"keywords":4,"overallStatus":195,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":202,"locationsCount":162},"100574489","phase-1-an-early-exploratory-clinical-study-of-gc012f-injection-in-the-treatment-of-refractory-generalized-myasthenia-gravis-100574489","NCT06759948","KY2024-853","Inclusion Criteria:\n\n* Subjects who meet all the following criteria can be included in this study:\n\n  1. Subjects or their legal representative voluntary signing the ICF, and willing and able to follow the procedure in this study.\n  2. Aged between 18 and 75 years old (including 75), no gender limitation;\n  3. Patients with confirmed refractory GMG, and the clinical classification according to MGFA is IIa-IVb (including IIa, IIb, IIIa, IIIb, IVa and IVb) at screening;\n  4. At screening, the MG-ADL score must be ≥6, with ocular symptoms accounting for less than 50% of the total score, and QMG must be ≥11;\n  5. Ineffectiveness of conventional treatment and\u002For lack of effective therapeutic options, referring to relapse or exacerbation after standard treatments with hormones, immunosuppressants (e.g., azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine A, cyclophosphamide, methotrexate, etc.), or biological agents (e.g., rituximab);\n  6. If the subject is currently using corticosteroids, the dose of prednisone must not exceed 30 mg\u002Fday (or the equivalent dose of other corticosteroids) and must remain stable for at least 4 weeks prior to infusion;\n  7. Only subjects with positive MG-specific autoantibodies: the titer\u002Flevel of anti-acetylcholine receptor (anti-AChR) antibodies or muscle-specific kinase (anti-MuSK) antibodies must be above the reference laboratory's upper normal limit (UNL);\n  8. The results of laboratory test during screening period shall meet all following criteria:\n\n     1. Neu ≥1.0 × 109\u002FL; Hb ≥8.0 g\u002FdL; PLT ≥50 × 109\u002FL;\n     2. ALT ≤3 × ULN; AST ≤3 × ULN; TBIL \\\u003C2 × ULN (DBIL ≤1.5 × ULN for subjects with Gilbert's syndrome)\n     3. Creatinine clearance (19.3 Appendix 3) ≥30 mL\u002Fmin;\n     4. APTT ≤1.5 × ULN, PT ≤1.5 × ULN;\n     5. LVEF ≥50% based on echocardiography, no findings of pericardial effusion.\n  9. Women of childbearing potential (WCBP) should:\n\n     1. Have a negative serum β human chorionic gonadotropin (β-hCG) pregnancy test confirmed by investigators during the screening period;\n     2. Agree to avoid breastfeeding during the study period until at least 1 year after the infusion of GC012F Injection or until two consecutive flow cytometry tests show the absence of CAR-T cells (whichever occurs later).\n  10. Any male subjects who have sexual partners and female subjects with childbearing potential shall agree to take effective contraceptive methods (e.g. oral contraceptive pills, intrauterine device or condoms) from the screening starting until at least 1 year post GC012F Injection infusion or until two consecutive flow cytometry tests show the absence of CAR-T cells (whichever occurs later). Male subjects must agree to use condoms during sexual contact with pregnant females or females with fertility for at least 1 year after the infusion of GC012F Injection, even if a successful vasectomy has been performed;\n  11. Venous access available for blood collection, and no contraindications for leukapheresis.\n\nExclusion Criteria:\n\n* Subjects who meet any of the following criteria will be excluded from the study:\n\n  1. Subjects have a history of severe hypersensitivity or allergy;\n  2. Any contraindication for fludarabine, cyclophosphamide and any component of the investigational product;\n  3. Administration of intravenous immunoglobulin or plasmapheresis or immunoadsorption treatment within 4 weeks prior to infusion;\n  4. Use of B-cell targeting drugs, including but not limited to rituximab, Belimumab, and Telitacicept, within 6 months prior to apheresis;\n  5. Used tacrolimus, cyclosporine, azathioprine, mycophenolate, mycophenolate, methotrexate, etc., within 3 weeks prior to apheresis;\n  6. Treatment with neonatal Fc receptor (FcRn) antagonists (such as Efgartigimod, etc.) within 3 weeks prior to apheresis\n  7. Use of complement inhibition therapy (such as eculizumab, etc.) within 3 weeks prior to apheresis;\n  8. Subjects with any of the following heart diseases:\n\n     1. Congestive heart failure (New York Heart Association (NYHA) Class III or IV);\n     2. Experienced unstable angina, myocardial infarction or underwent coronary artery bypass grafting (CABG) within 6 months prior to screening period;\n     3. Clinically significant ventricular arrhythmias or a history of unexplained syncope not due to vasovagal reaction or dehydration; or a QTc interval \\>480 ms during screening;\n     4. History of severe non-ischemic cardiomyopathy.\n     5. Serious cardiovascular abnormalities (such as abnormal brain natriuretic peptide BNP\u002F troponin and other indicators) and the investigators estimate that the patients should not be enrolled;\n  9. Accompanied by other uncontrolled malignant tumors. Subjects with the following conditions will be eligible: early-stage tumors that have received curative treatment (carcinoma in situ or stage I tumors, or non-ulcerated primary melanoma with a depth \\\u003C1 mm and no involvement of lymph nodes), basal cell skin cancer, skin squamous cell carcinoma, cervical carcinoma in situ, or breast cancer in situ that has received potential curative treatment;\n  10. Severe underlying medical conditions, such as:\n\n      1. Fungal, bacterial, viral or other infections or suspected fungal, bacterial, viral or other infections that cannot be controlled or require general intravenous administration (including tuberculosis infection where with clear evidence of disease activity);\n      2. Significant clinical evidence of dementia or mental status changes;\n      3. History of any central nervous system (CNS) or neurodegenerative diseases, (e.g., epilepsy, seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, psychiatric disorders).\n  11. Positive results in any of the following tests:\n\n      1. HIV antibody positive;\n      2. HBsAg positive; or HBcAb positive and HBV-DNA above the lower limit of detection of the analytical method;\n      3. HCV antibody positive with HCV RNA above the lower limit of detection of the analysis method; or known history of hepatitis C without completion of antiviral therapy for ≥24 weeks;\n      4. Syphilis antibody positive.\n  12. Received prior therapy of CAR-T for any target;\n  13. Previous organ transplant or allogeneic bone marrow transplants;\n  14. Surgery within 2 weeks prior to lymphodepletion or planning to have surgery during the study period (except for planned local anesthesia procedures, provided they are not performed within 2 weeks after infusion);\n  15. Receipt of a live-attenuated vaccine within 4 weeks prior to lymphodepletion;\n  16. Participation in any other clinical trial within 4 weeks prior to signing ICF, or the date of signing the ICF still within 5 half-lives of the drug from the last dose in the last clinical trial (whichever is longer);\n  17. Pregnant women or lactating women who do not agree to abstain from breastfeeding, men and women who have a fertility plan during participation in this study or within 1 year after receiving study treatment;\n  18. Based on the Columbia-Suicide Severity Rating Scale (C-SSRS), subjects had a current intention to commit suicide, i.e., C-SSRS item 4 on \"suicide\" (intention to act, But active suicidal ideation without a specific plan) or question 5 (active suicidal ideation with a specific plan and intent) answered \"yes\" or had a current history of suicidal behavior\n  19. Any situation that, in the investigator's judgment, may interfere with the subject's participation in the entire trial, confound trial results, or be contrary to the subject's best interests",{"count":63,"type":20},[193],"PHASE1",[25],"NOT_YET_RECRUITING","2024-12-29",{"date":198,"type":30},"2025-01-06",{"date":200,"type":20},"2025-02-15",{"date":182,"type":20},{"name":203,"class":161},"Chongbo Zhao"]