[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599794":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":31,"responsibleParty":69,"collaborators":24,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":24,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":24,"enrollmentInfo":80,"targetDuration":24,"studyType":83,"phases":84,"briefSummary":87,"conditions":88,"keywords":24,"overallStatus":34,"whyStopped":24,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Cartesian Therapeutics","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1: Decartes-08 to establish Maximum tolerated dose","EXPERIMENTAL","Intra-patient dose escalation arm with three dose levels over the course of six infusions of cell product.",[13],"Drug: Descartes-08",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 2: Decartes-08 infusions once weekly for 6 weeks","Descartes-08 infusions at the maximum tolerated dose level from Part 1.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Descartes-08","In part 1, three different doses will be administered to 3 participants with either disease indication to establish maximum tolerated dose In part 2, the MTD established in Part-1 will be administered as six once-weekly infusions to up to 10 participants per each of four baskets (cSLE, AAV, JDM and JMG) in an outpatient setting.",[9,15],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Cartesian Clinical Trials","CONTACT","617-231-8102","trials@cartesiantx.com",[32,54],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"H01- Children's National Hospital","RECRUITING","Washington D.C.","District of Columbia","20010","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-77.03637,38.89511,{"lat":44,"lon":43},[47,51],{"name":48,"role":28,"phone":49,"phoneExt":24,"email":50},"Emily Miller","202-476-4130","ejmiller@childrensnational.org",{"name":52,"role":53,"phone":24,"phoneExt":24,"email":24},"Anant Vatsayan, MD","PRINCIPAL_INVESTIGATOR",{"facility":55,"status":34,"city":56,"state":57,"zip":58,"country":38,"countryCode":39,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"H03- Washington University School of Medicine","St Louis","Missouri","63110",{"type":41,"coordinates":60},[61,62],-90.19789,38.62727,{"lat":62,"lon":61},[65],{"name":66,"role":28,"phone":67,"phoneExt":24,"email":68},"Goddard","314-454-6018","pedshemonctrialreferral@wustl.edu",{"type":70,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100599794","phase-1-descartes-08-for-children-adolescents-and-young-adults-with-autoimmune-disorders-100599794",false,"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.","ALL","12 Years",{"count":81,"type":82},50,"ESTIMATED","INTERVENTIONAL",[85,86],"PHASE1","PHASE2","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",[89,90,91,92],"Childhood-onset Systemic Lupus Erythematous","ANCA-Associated Vasculitis (AAV)","Juvenile Myasthenia Gravis","Juvenile Dermatomyositis","2026-04-07",{"date":95,"type":96},"2026-04-08","ACTUAL",{"date":98,"type":96},"2026-01-14",{"date":100,"type":82},"2028-12",{"name":5,"class":6},2]