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(Türkiye)",{"type":46,"coordinates":323},[324,325],32.85427,39.91987,{"lat":325,"lon":324},{"facility":328,"status":40,"city":329,"state":25,"zip":25,"country":321,"cosmosGeoPoint":330,"geoPoint":334,"contacts":25},"A17","Istanbul",{"type":46,"coordinates":331},[332,333],28.94966,41.01384,{"lat":333,"lon":332},{"facility":336,"status":40,"city":337,"state":25,"zip":25,"country":338,"cosmosGeoPoint":339,"geoPoint":343,"contacts":25},"A33","Birmingham","United Kingdom",{"type":46,"coordinates":340},[341,342],-1.89983,52.48142,{"lat":342,"lon":341},{"facility":345,"status":40,"city":346,"state":25,"zip":25,"country":338,"cosmosGeoPoint":347,"geoPoint":351,"contacts":25},"A51","Sheffield",{"type":46,"coordinates":348},[349,350],-1.4659,53.38297,{"lat":350,"lon":349},{"type":353,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100577511",false,"NCT06799247","Investigating an mRNA CAR T-cell Therapy, Known as Descartes-08, as a Potential Approach to Treat Myasthenia Gravis","A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial of Descartes-08 in Patients With Generalized Myasthenia Gravis (MG)","Inclusion Criteria:\n\n* Patient must be at least 18 years of age.\n* Patient must have generalized myasthenia gravis (gMG), Myasthenia Gravis Foundation of America (MGFA) clinical classification grades 2-4 at the time of Sscreening.\n* MG-Activities of Daily Living (MG ADL) total score ≥ 6.\n* Concomitant immunosuppressive drugs must be deemed necessary by the investigator. The dose must be stable for a minimum of 8 weeks prior to Baseline visit.\n* If a patient is using corticosteroids, the daily dose should not exceed 40 mg\u002Fday of prednisone equivalent. The dose must have been stable for a minimum of 8 weeks prior to Baseline visit.\n* Acetylcholine receptor autoantibody (anti-nAChR) titer or anti-AChR cluster antibody must be above the reference laboratory upper normal limit (UNL) and documented within the past 10 years of screening.\n* Patient must be willing to return for all study visits.\n* Patient must be able to give written informed consent.\n* Women of childbearing potential must agree to use highly effective birth control from Screening until 14 days post last dose of Descartes-08,\n\nExclusion Criteria:\n\n* Major chronic illness that is not well managed at the time of study entry and in the opinion of the investigator may increase the risk to the patient.\n* Diagnosis of gMG within 12 months of screening.\n* No history of systemic treatment for gMG other than acetylcholine esterase inhibitors.\n* Diagnosis of a neuromuscular disease other than gMG.\n* Patient is pregnant or lactating.\n* Treatment with intravenous immunoglobulin (IVIG) or plasma exchange within 4 weeks prior to the Baseline visit.\n* Treatment with rituximab or ocrelizumab within 12 months prior to Baseline visit; treatment with calcineurin inhibitors (e.g. tacrolimus, cyclosporine, cyclophosphamide), Neonatal Fc receptor antagonists, and\u002For other biologics within 3 weeks prior to planned leukapheresis and within 8 weeks prior to Baseline visit.\n* The patient has started treatment with a complement 5a (C5a) inhibitor, such as eculizumab, within 8 weeks of Baseline visit. (NOTE: patients who have been receiving a C5a inhibitor for more than 8 weeks and meet other criteria for enrollment are eligible for treatment).\n* Prior treatment with B-cell maturation antigen (BCMA)-directed therapy (e.g. monoclonal antibody, T-cell engager, or chimeric antigen receptor T-cell \\[CAR-T\\]).\n* Abnormal prothrombin (PT)\u002Finternational normalized ratio (INR) or partial thromboplastin time (PTT) increased \\> 1.5-fold above the normal range at Screening or patient is on anticoagulation therapy (except in cases of elevated PTT with documented lupus anticoagulant; or in patients who have been on stable doses of anticoagulation therapy for more than 6 months of venous thromboembolism (VTE) diagnosis; or in patients on stable doses of anticoagulation therapy for at least 8 weeks of atrial fibrillation diagnosis; these conditions will not be exclusionary unless, in the investigator's opinion, they make participation in the study unsafe).\n* Absolute neutrophil count (ANC) \\\u003C 1000 cells\u002Fmicroliter.\n* Hemoglobin \\\u003C 8.0 g\u002FdL.\n* Platelets \\\u003C 50,000\u002Fmm3.\n* Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) \\> 3x above normal.\n* Creatine clearance less than 30 mL\u002Fmin.\n* History of primary immunodeficiency, organ, or allogeneic bone marrow transplant.\n* Patients must be seronegative for hepatitis B surface antigen.\n* Patients must be seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patients must be tested for the presence of viremia by reverse transcriptase polymerase chain reaction (RT-PCR) and must be hepatitis C virus (HCV) ribonucleic acid (RNA) negative.\n* History of positive human immunodeficiency virus (HIV) or positive HIV at screening.\n* Active tuberculosis or positive QuantiFERON test at screening.\n* Any other clinical or laboratory abnormality that, in the opinion of the investigator, may jeopardize the subject's ability to participate in the study or could affect study outcome.\n* Any active significant cardiac or pulmonary disease that, in the opinion of the Principal Investigator, is significant and\u002For uncontrolled.\n\nNote: Patients with asthma and chronic obstructive pulmonary disease (COPD) controlled with inhaled medications are allowed.\n\n* History of malignancy that required treatment in the past 3 years, except for squamous cell carcinoma, basal cell carcinoma of the skin, or breast or early-stage colon cancer that is surgically removed and did not require adjuvant chemotherapy or radiotherapy.\n* Treatment with any investigational agent 4 weeks prior to screening or 5 half-lives of the investigational drug (whichever is longer).\n* Receipt of a live vaccination within 4 weeks prior to Baseline visit or intent to receive live vaccination during the study (Note: messenger RNA \\[mRNA\\]-based vaccines such as those against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are not considered live; likewise, the Janssen Covid-19 vaccine is not live).\n* History of significant recurrent infections or any active infection that in the opinion of the Investigator may interfere with the patient's participation in the opinion of the investigator.\n* Any known psychiatric illness that in the opinion of the Investigator, may interfere with the patient's participation in the study in the opinion of the investigator.","ALL","18 Years",{"count":363,"type":364},100,"ESTIMATED","INTERVENTIONAL",[367],"PHASE3","The AURORA Study is evaluating the safety, tolerability, and efficacy of an investigational mRNA CAR T-cell therapy known as Descartes-08 in adults with acetylcholine receptor autoantibody -positive generalized myasthenia gravis. Part 1 of the study will last around 6 months. For eligible participants, Part 2 will last around 8 months.",[370],"Myasthaenia Gravis",[372,373,374,375,376,377],"myasthenia gravis","CAR-T therapy","Cell Therapy","Decartes-8","BMCA","B cell maturation antigen","2026-03-23",{"date":380,"type":381},"2026-03-24","ACTUAL",{"date":383,"type":381},"2025-05-06",{"date":385,"type":364},"2027-09-30",{"name":5,"class":6},34]