[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06154252":3,"trial-entities:NCT06154252":622,"trial-summary:NCT06154252":626},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":27,"study_type":35,"primary_purpose":36,"phases":37,"enrollment_info":40,"interventions":43,"primary_outcomes":55,"secondary_outcomes":68,"sex":106,"minimum_age":107,"maximum_age":108,"healthy_volunteers":15,"eligibility_criteria":109,"std_ages":129,"locations":133,"central_contacts":607,"overall_officials":612,"references":616,"see_also_links":621},"NCT06154252","CAB-201-002","RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy","A Phase 1\u002F2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T Cells (CABA-201) in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy","RECRUITING","2028-07","2026-08","2026-08-21","2023-12-20","Cabaletta Bio","INDUSTRY",false,"RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy","Idiopathic inflammatory myopathies (IIMs, or myositis) are a group of rare autoimmune diseases characterized by inflammation and muscle weakness. Though the cause of IIM is not well understood, some subtypes of IIM, including dermatomyositis (DM), anti-synthetase syndrome (ASyS), immune-mediated necrotizing myopathy (IMNM), and juvenile idiopathic inflammatory myopathy (JIIM), are thought to involve B cells that cause the body to attack different tissues in the body. This study is being conducted to evaluate the safety and efficacy of an investigational cell therapy, CABA-201, that can be given to patients with DM, ASyS, IMNM, or JIIM who have active disease. A single dose of CABA-201 in combination with cyclophosphamide (CY) and fludarabine (FLU) will be evaluated.",[19,20,21,22,23,24,25,26],"Idiopathic Inflammatory Myopathy","Dermatomyositis","Anti-Synthetase Syndrome","Immune-Mediated Necrotizing Myopathy","Juvenile Dermatomyositis","Juvenile Polymyositis","Juvenile Idiopathic Inflammatory Myopathy (JIIM)","Juvenile Myositis",[28,29,30,31,19,32,20,33,34,23,24,25,26],"CABA-201","Autoimmune Disease","Anti-CD19 CAR-T therapy","Cellular Therapy","Myositis","Anti-synthetase Syndrome","Immune-mediated Necrotizing Myopathy","INTERVENTIONAL","TREATMENT",[38,39],"PHASE2","PHASE3",{"count":41,"type":42},74,"ESTIMATED",[44],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":52},"BIOLOGICAL","CABA-201 following preconditioning with fludarabine and cyclophosphamide","Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide",[49,50,51],"CABA-201 Phase 1\u002F2","CABA-201 Phase 2b - Sub-study 1","CABA-201 Phase 2b - Sub-study 2",[53,54],"Rese-cel","Resecabtagene autoleucel",[56,60,64],{"measure":57,"description":58,"timeFrame":59},"Phase 1\u002F2: Incidence and severity of adverse events (AEs)","Incidence and severity of AEs","Up to 28 days after CABA-201 infusion",{"measure":61,"description":62,"timeFrame":63},"Phase 2b Sub-study 1: Proportion of DM & ASyS subjects achieving at least a moderate Total Improvement Score (TIS) without any immunomodulatory medications and no or low dose of steroids","≥40 on the TIS, a composite measure ranging from 0 to 100, derived from six Core Set Measures, with higher scores indicating greater clinical improvement","Within 16 weeks",{"measure":65,"description":66,"timeFrame":67},"Phase 2b Sub-study 2: Proportion of subjects with IMNM achieving at least a minimal TIS without any immunomodulatory medications and no or low dose of steroids","≥20 on the TIS, a composite measure ranging from 0 to 100, derived from six Core Set Measures, with higher scores indicating greater clinical improvement","Within 24 weeks",[69,73,76,79,83,86,89,92,95,98,100,103],{"measure":70,"description":71,"timeFrame":72},"Incidence of adverse events and laboratory abnormalities","Incidence and severity of AEs, including changes in laboratory values and vital signs","Up to 156 weeks (Phase 1\u002F2) and through 52 weeks (Sub-study 1 and 2)",{"measure":74,"description":75,"timeFrame":72},"Pharmacodynamics (PD)","Levels of B cells in the blood",{"measure":77,"description":78,"timeFrame":72},"Pharmacokinetics (PK)","Levels of CABA-201-positive T cells in the blood",{"measure":80,"description":81,"timeFrame":82},"Change in disease-related biomarkers of muscle inflammation","Levels of muscle enzymes (CK, LDH, AST, ALT, and aldolase) in serum","Up to 156 weeks (Phase 1\u002F2)",{"measure":84,"description":85,"timeFrame":82},"Change in autoantibody-related biomarkers","Levels of autoantibodies from the Myositis-Specific Autoantibody Panel (e.g., MDA-5, Jo-1, and HMGCR) in the serum",{"measure":87,"description":62,"timeFrame":88},"Proportion of DM subjects achieving at least a moderate TIS without any immunomodulatory medications and no or low dose of steroids","Week 16 (Sub-study 1)",{"measure":90,"description":91,"timeFrame":88},"Mean change from baseline on the MMT-8 in subjects with DM and ASyS without any immunomodulatory medications and no or low dose of steroids","MMT-8 measures muscle strength on a scale ranging from 0 to 150 points, where higher scores reflect greater muscle strength",{"measure":93,"description":94,"timeFrame":88},"Proportion of DM and ASyS subjects achieving a major TIS response without any immunomodulatory medications and no or low dose of steroids","≥60 on the TIS, a composite measure ranging from 0 to 100, derived from six Core Set Measures, with higher scores indicating greater clinical improvement",{"measure":96,"description":62,"timeFrame":97},"Proportion of subjects with DM & ASyS achieving moderate TIS without any immunomodulatory medications on no or low dose of steroids","Week 52 (Sub-study 1)",{"measure":99,"description":62,"timeFrame":97},"Proportion of subjects with DM achieving moderate TIS without any immunomodulatory medications on no or low dose of steroids",{"measure":101,"description":91,"timeFrame":102},"Mean change from baseline on the MMT-8 in subjects with IMNM without any immunomodulatory medications and no or low dose of steroids","Week 24 (Sub-study 2)",{"measure":104,"description":66,"timeFrame":105},"Proportion of subjects with IMNM achieving at least minimal TIS response without immunomodulatory medications and no or low dose of steroids","Week 52 (Sub-study 2)","ALL","6 Years","75 Years",{"inclusion":110,"exclusion":118,"raw_text":128},[111,112,113,114,115,116,112,117],"Age ≥18 and ≤75","A clinical diagnosis of IIM, based on the 2017 The European League Against Rheumatism\u002FAmerican College of Rheumatology classification criteria","Diagnosis of DM, ASyS, or IMNM","Evidence of active disease, despite prior or current treatment with standard of care treatments, as defined by the presence of elevated creatine kinase (CK), DM rash, or active disease on muscle biopsy, magnetic resonance imaging (MRI), or electromyography","Presence of muscle weakness","Age ≥6 and ≤17 years at enrollment","Evidence of active disease, despite prior or current treatment with standard of care treatments, as defined by the presence of elevated muscle enzymes, DM rash, or active disease on muscle biopsy, magnetic resonance imaging (MRI), or electromyography",[119,120,121,122,123,124,125,126,119,120,121,127,123,124,125,126],"Contraindication to leukapheresis","History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites","Active infection requiring medical intervention at screening","Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections","Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures","Significant lung or cardiac impairment","Previous CAR T cell therapy","Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant","Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections.","Adult Cohorts\n\nInclusion Criteria:\n\n* Age ≥18 and ≤75\n* A clinical diagnosis of IIM, based on the 2017 The European League Against Rheumatism\u002FAmerican College of Rheumatology classification criteria\n* Diagnosis of DM, ASyS, or IMNM\n* Evidence of active disease, despite prior or current treatment with standard of care treatments, as defined by the presence of elevated creatine kinase (CK), DM rash, or active disease on muscle biopsy, magnetic resonance imaging (MRI), or electromyography\n* Presence of muscle weakness\n\nOther protocol-defined criteria apply.\n\nExclusion Criteria:\n\n* Contraindication to leukapheresis\n* History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites\n* Active infection requiring medical intervention at screening\n* Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections\n* Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures\n* Significant lung or cardiac impairment\n* Previous CAR T cell therapy\n* Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant\n\nOther protocol-defined criteria apply.\n\nJuvenile Cohort\n\nInclusion Criteria:\n\n* Age ≥6 and ≤17 years at enrollment\n* A clinical diagnosis of IIM, based on the 2017 The European League Against Rheumatism\u002FAmerican College of Rheumatology classification criteria\n* Evidence of active disease, despite prior or current treatment with standard of care treatments, as defined by the presence of elevated muscle enzymes, DM rash, or active disease on muscle biopsy, magnetic resonance imaging (MRI), or electromyography\n\nOther protocol-defined criteria apply.\n\nExclusion Criteria:\n\n* Contraindication to leukapheresis\n* History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites\n* Active infection requiring medical intervention at screening\n* Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections.\n* Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures\n* Significant lung or cardiac impairment\n* Previous CAR T cell therapy\n* Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant\n\nOther protocol-defined criteria apply.",[130,131,132],"CHILD","ADULT","OLDER_ADULT",[134,152,166,180,193,207,222,232,247,257,274,287,302,317,332,345,359,369,383,397,411,424,437,451,461,473,487,499,509,524,538,554,570,580,593],{"facility":135,"status":8,"city":136,"state":137,"zip":138,"country":139,"contacts":140,"geoPoint":149},"University of California Irvine - Accepting Adult Patients","Orange","California","92868","United States",[141,146],{"name":142,"role":143,"phone":144,"email":145},"Alpha Clinic","CONTACT","949-824-3990","alphaclinic@uci.edu",{"name":147,"role":148},"Tahseen Mozaffar, MD","PRINCIPAL_INVESTIGATOR",{"lat":150,"lon":151},33.78779,-117.85311,{"facility":153,"status":8,"city":154,"state":137,"zip":155,"country":139,"contacts":156,"geoPoint":163},"University of California, San Francisco Benioff Children's Hospital - Accepting Young Adult and Juvenile Patients","San Francisco","94158",[157,161],{"name":158,"role":143,"phone":159,"email":160},"Zilan Zheng","415-353-1301","Zilan.Zheng@ucsf.edu",{"name":162,"role":148},"Susan Kim, MD, MMSc",{"lat":164,"lon":165},37.77493,-122.41942,{"facility":167,"status":8,"city":168,"state":169,"zip":170,"country":139,"contacts":171,"geoPoint":177},"Children's Hospital Colorado - Accepting Juvenile Patients","Aurora","Colorado","80046",[172,175],{"name":173,"role":143,"email":174},"Dr. Kentaro Yomogida","Kentaro.Yomogida@childrenscolorado.org",{"name":176,"role":148},"Dr. Kentaro Yomogida, MD",{"lat":178,"lon":179},39.72943,-104.83192,{"facility":181,"status":8,"city":182,"state":183,"zip":184,"country":139,"contacts":185,"geoPoint":190},"Mayo Clinic Florida - Accepting Adult Patients","Jacksonville","Florida","32224",[186],{"name":187,"role":143,"phone":188,"email":189},"Gabrielle Pariseau","904-953-5549","pariseau.gabrielle@mayo.edu",{"lat":191,"lon":192},30.33218,-81.65565,{"facility":194,"status":8,"city":195,"state":183,"zip":196,"country":139,"contacts":197,"geoPoint":204},"Johns Hopkins All Children's Hospital - Accepting Juvenile Patients","St. Petersburg","33701",[198,202],{"name":199,"role":143,"phone":200,"email":201},"Laura Escobar","727-767-2946","llabarr2@jh.edu",{"name":203,"role":148},"Natalie Booth, DO",{"lat":205,"lon":206},27.77086,-82.67927,{"facility":208,"status":8,"city":209,"state":210,"zip":211,"country":139,"contacts":212,"geoPoint":219},"Children's Healthcare of Atlanta - Accepting Juvenile Patients","Atlanta","Georgia","30029",[213,217],{"name":214,"role":143,"phone":215,"email":216},"Judson Russell","404-785-7263","Judson.russell@choa.org",{"name":218,"role":148},"Shanmuganathan Chandrakasan, MD",{"lat":220,"lon":221},33.749,-84.38798,{"facility":223,"status":8,"city":209,"state":210,"zip":224,"country":139,"contacts":225,"geoPoint":231},"Emory University - Accepting Adult Patients","30032",[226,229],{"name":227,"role":143,"email":228},"John Varghese","john.varghese@emory.edu",{"name":230,"role":148},"Prateek Chandrashekar Gandiga, MD, FACP",{"lat":220,"lon":221},{"facility":233,"status":8,"city":234,"state":235,"zip":236,"country":139,"contacts":237,"geoPoint":244},"Ann & Robert H. Lurie Children's Hospital of Chicago - Accepting Young Adult and Juvenile Patients","Chicago","Illinois","60611",[238,242],{"name":239,"role":143,"phone":240,"email":241},"Tyler Sorensen","312-277-6828","tsorensen@luriechildrens.org",{"name":243,"role":148},"Pooja N. Patel, DO",{"lat":245,"lon":246},41.85003,-87.65005,{"facility":248,"status":8,"city":234,"state":235,"zip":236,"country":139,"contacts":249,"geoPoint":256},"Northwestern Memorial Hospital - Accepting Adult Patients",[250,254],{"name":251,"role":143,"phone":252,"email":253},"Kaitlin King","312-695-0990","autoimmunesct@nm.org",{"name":255,"role":148},"Dr. George Georges, MD",{"lat":245,"lon":246},{"facility":258,"status":8,"city":234,"state":235,"zip":259,"country":139,"contacts":260,"geoPoint":273},"The University of Chicago Medical Center - Accepting Adult and Juvenile Patients","60637",[261,265,268,270],{"name":262,"role":143,"phone":263,"email":264},"Dr. Iazsmin Ventura, MD - Adult patient contact","773-702-6619","iventura@uchicago.edu; Dequana.jones@bsd.uchicago.edu",{"name":266,"role":143,"email":267},"Dr. Cuoghi Edens, MD, FAAP - Juvenile patient contact","cedens@bsd.uchicago.edu; Sydni.Hill@bsd.uchicago.edu",{"name":269,"role":148},"Dr. Iazsmin Ventura, MD",{"name":271,"role":272},"Dr. Cuoghi Edens, MD, FAAP","SUB_INVESTIGATOR",{"lat":245,"lon":246},{"facility":275,"status":8,"city":276,"state":277,"zip":278,"country":139,"contacts":279,"geoPoint":284},"University of Kansas Medical Center - Accepting Adult Patients","Kansas City","Kansas","66160",[280],{"name":281,"role":143,"phone":282,"email":283},"Samantha Colgan","913-945-9938","scolgan@kumc.edu",{"lat":285,"lon":286},39.11417,-94.62746,{"facility":288,"status":8,"city":289,"state":290,"zip":291,"country":139,"contacts":292,"geoPoint":299},"National Institutes of Health - Accepting Adult and Juvenile Patients","Bethesda","Maryland","20892",[293,297],{"name":294,"role":143,"phone":295,"email":296},"Julie Thompson","301-480-3191","Julie.thompson@nih.gov",{"name":298,"role":148},"Andrew Mammen, M.D., Ph.D.",{"lat":300,"lon":301},38.98067,-77.10026,{"facility":303,"status":8,"city":304,"state":305,"zip":306,"country":139,"contacts":307,"geoPoint":314},"Boston Children's Hospital - Accepting Young Adults and Juvenile Patients","Boston","Massachusetts","02115",[308,312],{"name":309,"role":143,"phone":310,"email":311},"Kyle McBrearty","617-355-2780","kyle.mcbrearty@childrens.harvard.edu",{"name":313,"role":148},"Susan Prockop, MD",{"lat":315,"lon":316},42.35843,-71.05977,{"facility":318,"status":8,"city":319,"state":320,"zip":321,"country":139,"contacts":322,"geoPoint":329},"University of Michigan - Accepting Young Adult and Juvenile Patients","Ann Arbor","Michigan","48105",[323,327],{"name":324,"role":143,"phone":325,"email":326},"Abigail Whalen","734-615-4466","abigaiwh@med.umich.edu",{"name":328,"role":148},"Dr. Jennifer Agrusa, MD",{"lat":330,"lon":331},42.27756,-83.74088,{"facility":333,"status":8,"city":334,"state":335,"zip":336,"country":139,"contacts":337,"geoPoint":342},"Mayo Clinic - Accepting Adult Patients","Rochester","Minnesota","55902",[338],{"name":339,"role":143,"phone":340,"email":341},"Bridget Neja","507-266-9150","neja.bridget@mayo.edu",{"lat":343,"lon":344},44.02163,-92.4699,{"facility":346,"status":8,"city":347,"state":347,"zip":348,"country":139,"contacts":349,"geoPoint":356},"Hospital for Special Surgery - Accepting Adult and Juvenile Patients","New York","10021",[350,354],{"name":351,"role":143,"phone":352,"email":353},"Janvi Bhatia","212-774-2123","bhatiaj@hss.edu",{"name":355,"role":148},"David R. Fernandez, MD, PhD",{"lat":357,"lon":358},40.71427,-74.00597,{"facility":360,"status":8,"city":347,"state":347,"zip":348,"country":139,"contacts":361,"geoPoint":368},"Memorial Sloan Kettering Cancer Center - Accepting Adult and Juvenile Patients",[362,366],{"name":363,"role":143,"phone":364,"email":365},"Atifah Osrat","646-608-2091","osrata1@mskcc.org",{"name":367,"role":148},"Jae Park, MD",{"lat":357,"lon":358},{"facility":370,"status":8,"city":371,"state":347,"zip":372,"country":139,"contacts":373,"geoPoint":380},"Children's Hospital at Montefiore - Accepting Young Adult and Juvenile Patients","The Bronx","10467",[374,378],{"name":375,"role":143,"phone":376,"email":377},"Emily Gillies","718-696-2402","egillies@montefiore.org",{"name":379,"role":148},"Dr. Dawn Wahezi, MD, MS",{"lat":381,"lon":382},40.84985,-73.86641,{"facility":384,"status":8,"city":385,"state":386,"zip":387,"country":139,"contacts":388,"geoPoint":394},"University of North Carolina at Chapel Hill - Accepting Adult Patients","Chapel Hill","North Carolina","27599",[389,392],{"name":390,"role":143,"email":391},"Leah Luizza","leah.luizza@med.unc.edu",{"name":393,"role":148},"Saira Sheikh, MD",{"lat":395,"lon":396},35.9132,-79.05584,{"facility":398,"status":8,"city":399,"state":386,"zip":400,"country":139,"contacts":401,"geoPoint":408},"Duke University Medical Center - Accepting Young Adults and Juvenile Patients","Durham","27710",[402,406],{"name":403,"role":143,"phone":404,"email":405},"Lynn Rodgers, MS","919-668-2953","Lynn.rodgers@duke.edu",{"name":407,"role":148},"Kaveh Ardalan, MD, MS",{"lat":409,"lon":410},35.99403,-78.89862,{"facility":412,"status":8,"city":413,"state":414,"zip":415,"country":139,"contacts":416,"geoPoint":421},"Oregon Health & Science University - Accepting Adult Patients","Portland","Oregon","97239",[417],{"name":418,"role":143,"phone":419,"email":420},"Katie Lewis","503-908-9724","lewiskat@ohsu.edu",{"lat":422,"lon":423},45.52345,-122.67621,{"facility":425,"status":8,"city":426,"state":427,"zip":428,"country":139,"contacts":429,"geoPoint":434},"Children's Hospital of Philadelphia - Accepting Young Adult and Juvenile Patients","Philadelphia","Pennsylvania","19104",[430,432],{"name":431,"role":143,"email":431},"CARTintake@chop.edu",{"name":433,"role":148},"Dr. Caitlin Elgarten, MD, MSCE",{"lat":435,"lon":436},39.95238,-75.16362,{"facility":438,"status":8,"city":439,"state":427,"zip":440,"country":139,"contacts":441,"geoPoint":448},"UPMC Children's Hospital of Pittsburgh - Accepting Juvenile Patients","Pittsburgh","15224",[442,446],{"name":443,"role":143,"phone":444,"email":445},"Vibha Chauhan, PhD","412-692-7924","Vibha.chauhan@chp.edu",{"name":447,"role":148},"Kathryn Torok, MD",{"lat":449,"lon":450},40.44062,-79.99589,{"facility":452,"status":8,"city":439,"state":427,"zip":453,"country":139,"contacts":454,"geoPoint":460},"UPMC Arthritis and Autoimmunity Center - Accepting Adult Patients","15261",[455,458],{"name":456,"role":143,"email":457},"Carol Oriss","orissca@upmc.edu",{"name":459,"role":148},"Jeremy Tilstra, MD",{"lat":449,"lon":450},{"facility":462,"status":8,"city":463,"state":464,"zip":465,"country":139,"contacts":466,"geoPoint":470},"Vanderbilt University Medical Center - Accepting Adult Patients","Nashville","Tennessee","37232",[467],{"name":468,"role":143,"email":469},"Jon Williams","jon.williams@vumc.org",{"lat":471,"lon":472},36.16589,-86.78444,{"facility":474,"status":8,"city":475,"state":476,"zip":477,"country":139,"contacts":478,"geoPoint":484},"University of Texas Southwestern Medical Center - Accepting Juvenile Patients","Dallas","Texas","75390",[479,482],{"name":480,"role":143,"email":481},"Dr. Samuel John","dtpteam@childrens.com",{"name":483,"role":148},"Samuel John, MD",{"lat":485,"lon":486},32.78306,-96.80667,{"facility":488,"status":8,"city":489,"state":476,"zip":490,"country":139,"contacts":491,"geoPoint":496},"Houston Methodist Hospital - Accepting Adult Patients","Houston","77030",[492],{"name":493,"role":143,"phone":494,"email":495},"Amelia A. Nounes, MSN, RN, CCRP","346-356-3639","aanounes@houstonmethodist.org",{"lat":497,"lon":498},29.76328,-95.36327,{"facility":500,"status":8,"city":489,"state":476,"zip":490,"country":139,"contacts":501,"geoPoint":508},"University of Texas MD Anderson Cancer Center - Accepting Adult Patients",[502,506],{"name":503,"role":143,"phone":504,"email":505},"Christina Amos Briggs, BSN, RN","713-563-5076","cbamos@mdanderson.org",{"name":507,"role":148},"Huifang (Linda) Lu, MD",{"lat":497,"lon":498},{"facility":510,"status":8,"city":511,"state":512,"zip":513,"country":139,"contacts":514,"geoPoint":521},"Primary Children's Hospital\u002FUniversity of Utah - Accepting Juvenile Patients","Salt Lake City","Utah","84113",[515,519],{"name":516,"role":143,"phone":517,"email":518},"Morgan Badgley - Research Coordinator","801-662-4812","morgan.badgley@hsc.utah.edu",{"name":520,"role":148},"Aimee Ogden Hersh, MD",{"lat":522,"lon":523},40.76078,-111.89105,{"facility":525,"status":8,"city":526,"state":527,"zip":528,"country":139,"contacts":529,"geoPoint":535},"Seattle Children's Research Institute - Accepting Juvenile Patients","Seattle","Washington","98105",[530,534],{"name":531,"role":143,"phone":532,"email":533},"Dr. Susan Shenoi, MD, MS","206-987-2193","susan.shenoi@SeattleChildrens.org",{"name":531,"role":148},{"lat":536,"lon":537},47.60621,-122.33207,{"facility":539,"status":540,"city":541,"state":542,"zip":543,"country":139,"contacts":544,"geoPoint":551},"Children's Wisconsin Pediatric Rheumatology -Accepting Young Adult and Juvenile Patients","NOT_YET_RECRUITING","Milwaukee","Wisconsin","53226",[545,549],{"name":546,"role":143,"phone":547,"email":548},"Erin Hammelev - Research Coordinator","414-337-7064","ehammele@mcw.edu",{"name":550,"role":148},"Sara Sabbagh, DO",{"lat":552,"lon":553},43.0389,-87.90647,{"facility":555,"status":8,"city":556,"zip":557,"country":558,"contacts":559,"geoPoint":567},"Kings College Hospital NHS Foundation Trust - Accepting Adult Patients","London","SE5 9RS","United Kingdom",[560,565],{"name":561,"role":143,"phone":562,"phoneExt":563,"email":564},"Rheumatology Research Team","0207 848 0214","0628","Kch-tr.CRDresearch@nhs.net",{"name":566,"role":148},"Patrick Gordon, PhD, FRCP, MBBS",{"lat":568,"lon":569},51.50853,-0.12574,{"facility":571,"status":8,"city":556,"zip":572,"country":558,"contacts":573,"geoPoint":579},"University College London Hospitals NHS Foundation Trust - Accepting Adult Patients","WC1N 3BG",[574,578],{"name":575,"role":143,"phone":576,"email":577},"Dr. Pedro Machado, FRCP, PhD","020 3456 7890","uclh.car-ttrials@nhs.net",{"name":575,"role":148},{"lat":568,"lon":569},{"facility":581,"status":8,"city":582,"zip":583,"country":558,"contacts":584,"geoPoint":590},"Manchester Royal Infirmary - Accepting Adult Patients","Manchester","M13 9WL",[585,589],{"name":586,"role":143,"phone":587,"email":588},"Eleni Tholouli, MD, PhD, MRCP(UK), FRCPath","01612765052","Eleni.Tholouli@mft.nhs.uk",{"name":586,"role":148},{"lat":591,"lon":592},53.48095,-2.23743,{"facility":594,"status":8,"city":595,"zip":596,"country":558,"contacts":597,"geoPoint":604},"Salford Royal Hospital - Accepting Adult Patients","Salford","M6 8HD",[598,602],{"name":599,"role":143,"phone":600,"email":601},"Michelle Beswick","07759 136787","Rheumatology.Research@nca.nhs.uk",{"name":603,"role":148},"Hector Chinoy, PhD, FRCP, MSc, BMBS, BMedSci",{"lat":605,"lon":606},53.48771,-2.29042,[608],{"name":13,"role":143,"phone":609,"phoneExt":610,"email":611},"267-759-3100","4444","clinicaltrials@cabalettabio.com",[613],{"name":614,"affiliation":13,"role":615},"Medical Director","STUDY_CHAIR",[617],{"pmid":618,"type":619,"citation":620},"39245937","DERIVED","Volkov J, Nunez D, Mozaffar T, Stadanlick J, Werner M, Vorndran Z, Ellis A, Williams J, Cicarelli J, Lam Q, Furmanak T, Schmitt C, Hadi-Nezhad F, Thompson D, Miller C, Little C, Chang D, Basu S. Case study of CD19 CAR T therapy in a subject with immune-mediate necrotizing myopathy treated in the RESET-Myositis phase I\u002FII trial. Mol Ther. 2024 Nov 6;32(11):3821-3828. doi: 10.1016\u002Fj.ymthe.2024.09.009. Epub 2024 Sep 7.",[],{"nct_id":4,"conditions":623,"biomarkers":625},[21,624,20,19,22,24],"Childhood Dermatomyositis",[],{"nct_id":4,"found":627,"summary":628,"prompt_version":638},true,{"design":629,"status":630,"heading":631,"summary":632,"follow_up":633,"word_count":634,"commitments":635,"compensation":636,"drugs_mentioned":637},"This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It plans to enroll 74 participants.","completed","RESET-Myositis: CABA-201 for Idiopathic Inflammatory Myopathy","This study, called RESET-Myositis, is looking at a new cell therapy called CABA-201 for people with active idiopathic inflammatory myopathy (IIM), which includes conditions like dermatomyositis (DM), anti-synthetase syndrome (ASyS), and immune-mediated necrotizing myopathy (IMNM). IIMs are rare autoimmune diseases that cause inflammation and muscle weakness. This study aims to see how safe and effective CABA-201 is when given as a single infusion after you receive other medicines called fludarabine and cyclophosphamide. To join, you must be between 18 and 75 years old with an IIM diagnosis and active disease, even if you've had other treatments. The study will measure side effects and how many people improve without needing other medications or high doses of steroids.","The study will track side effects for up to 28 days after the CABA-201 infusion, and measure improvement for up to 16 or 24 weeks depending on your specific condition.",116,"You would receive a single intravenous infusion of CABA-201 after preconditioning with fludarabine and cyclophosphamide.","Not stated in the trial record.",[],"v2"]