[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Cartesian Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":102},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,72],{"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":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100623051","phase-2-descartes-08-in-autoantibody-myositis-100623051",false,"NCT07391605","Descartes-08 in Autoantibody Myositis","A Randomized Double-Blind Placebo-Controlled Study to Evaluate Efficacy, Safety, and Tolerability of Descartes-08 in Patients With Dermatomyositis and Antisynthetase Syndrome","Inclusion Criteria:\n\n* Confirmed diagnosis of one of the following:\n\nDermatomyositis (DM): Probability score ≥55% on the 2017 EULAR\u002FACR (European Alliance of Associations of Rheumatology\u002F American College of Rheumatology) criteria for classification of dermatomyositis (corresponding to diagnosis of 'probable or definite' DM). OR Antisynthetase Syndrome (ASyS): Diagnosis based on ACR\u002FEULAR Classification Criteria (1).\"\n\n* Participants must have dermatomyositis or antisynthetase syndrome with muscle and\u002For skin involvement.\n* Refractory or intolerance to standard therapy.\n* Stable background immunosuppressive therapy for ≥8 weeks.\n* Adequate hematologic, renal, hepatic, and pulmonary function (SpO₂ ≥92% on room air).\n* Informed consent, compliance with visits, contraception, and vaccinations required.\n\nExclusion Criteria:\n\n* Isolated interstitial lung disease (ILD) without muscle or skin involvement\n\n  * Severe irreversible muscle damage or advanced weakness (e.g., wheelchair-bound).\n  * Interstitial lung disease (ILD) requiring oxygen, severe pulmonary impairment (FVC ≤45%, DLCO ≤40%), or pulmonary hypertension.\n  * Other inflammatory myopathies (PM, IMNM, IBM, cancer- or drug-induced myositis, overlap myositis except Sjögren's).\n  * Other severe neuromuscular, cardiac, pulmonary, or systemic autoimmune diseases requiring immunosuppression.\n  * Significant uncontrolled chronic illnesses or psychiatric conditions interfering with participation.\n  * Pregnancy or lactation.\n  * Recent use of prohibited immunosuppressants\u002Fbiologics or investigational agents (per washout periods).\n  * Live vaccination within 4 weeks.\n  * History of primary immunodeficiency, organ or bone marrow transplant.\n  * Active or uncontrolled infections: HBV, HCV, HIV, tuberculosis, or recurrent\u002Fsevere infections.","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a randomized, double-blind, placebo-controlled phase 2 study to evaluate the efficacy, safety and tolerability of an autologous T-cells expressing a chimeric antigen receptor (CAR) directed to B-Cell maturation antigen (BCMA) in patients with autoantibody-mediated myositis, including antisynthetase syndrome (ASyS) and dermatomyositis (DM).",[26],"Antisynthetase Syndrome",[28,29,30,31,32],"MYOSITIS","DESCARTES-08","MRNA CAR-T","TOTAL IMPROVEMENT SCORES","CDASI","RECRUITING","2026-04-22",{"date":36,"type":37},"2026-04-23","ACTUAL",{"date":39,"type":20},"2026-04-28",{"date":41,"type":20},"2028-05",{"name":43,"class":44},"Cartesian Therapeutics","INDUSTRY",2,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":45},"100599794","phase-1-descartes-08-for-children-adolescents-and-young-adults-with-autoimmune-disorders-100599794","NCT07089121","Descartes-08 for Children, Adolescents, and Young Adults With Autoimmune Disorders","Descartes-08 for Children, Adolescents and Young Adults With Childhood-onset Systemic Lupus Erythematosus, ANCA-associated Vasculitis, Juvenile Myasthenia Gravis, and Juvenile Dermatomyositis","Inclusion Criteria:\n\n* At least age 12\n* definitive diagnosis of childhood-onset systemic lupus erythematous, juvenile Myasthenie gravis, juvenile dermatomyositis and AAV\n* Signs and symptoms of moderate disease\n* History of systemic treatment\n* Parent\u002FGuardian\u002FPatient must be able to give written informed consent\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* Abnormal PT\u002FINR or PTT increased \\> 1.5-fold 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 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* ANC \\\u003C 1000 cells\u002Fmicroliter ;\n* Hemoglobin \\\u003C 8.0 g\u002FdL ;\n* Platelets \\\u003C 50,000\u002Fmm3 (NOTE: platelet transfusions are permissible);\n* ALT and\u002For AST with GGT ≥ 3× upper limit of normal\n* Creatine Clearance less than 30mL\u002Fmin \u002F1.73 m2;\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 RT-PCR and must be HCV RNA negative;\n* History of positive HIV or positive HIV at screening;\n* Active tuberculosis or positive QuantiFERON test at screening;\n* Any other laboratory abnormality that, in the opinion of the investigator, may jeopardize the subject's ability to participate in the study; 23. Any active significant cardiac or pulmonary disease not related to the primary indication as determined by principal investigator and medical monitor Note: Patients with asthma and COPD controlled with inhaled medications are allowed; 24. Any arterial or venous thromboembolic events in the past 3 months; 25. History of malignancy that required treatment in the past 3 years except for successfully-treated squamous cell and\u002For basal cell carcinoma of the skin and\u002For breast or colon cancer that is surgically removed and did not require adjuvant chemotherapy or radiotherapy; 26. Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer); 27. Receipt of a live vaccination within 4 weeks prior to baseline (Day 1) or intent to receive live vaccination during the study (Note: mRNA-based vaccines such as those against SARS-CoV-2 are not considered live; likewise, the Janssen Covid-19 vaccine is not live); 28. History of significant recurrent infections or any active infection that may interfere with the patient's participation in the opinion of the investigator; 29. Any known psychiatric illness that may interfere with the patient's participation in the study in the opinion of the investigator.","12 Years",{"count":55,"type":20},50,[57,23],"PHASE1","Safety, tolerability and efficacy of Descarte-08 in children, adolescents and young adults with childhood-onset systemic lupus erythematosus, ANCA-associated vasculitis, juvenile myasthenia gravis, and juvenile dermatomyositis",[60,61,62,63],"Childhood-onset Systemic Lupus Erythematous","ANCA-Associated Vasculitis (AAV)","Juvenile Myasthenia Gravis","Juvenile Dermatomyositis","2026-04-07",{"date":66,"type":37},"2026-04-08",{"date":68,"type":37},"2026-01-14",{"date":70,"type":20},"2028-12",{"name":43,"class":44},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},"100577511","phase-3-investigating-an-mrna-car-t-cell-therapy-known-as-descartes-08-as-a-potential-approach-to-treat-myasthenia-gravis-100577511","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.",{"count":80,"type":20},100,[82],"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.",[85],"Myasthaenia Gravis",[87,88,89,90,91,92],"myasthenia gravis","CAR-T therapy","Cell Therapy","Decartes-8","BMCA","B cell maturation antigen","2026-03-23",{"date":95,"type":37},"2026-03-24",{"date":97,"type":37},"2025-05-06",{"date":99,"type":20},"2027-09-30",{"name":43,"class":44},34,""]