[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652789":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":53,"collaborators":55,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":19,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":19,"enrollmentInfo":68,"targetDuration":19,"studyType":71,"phases":72,"briefSummary":75,"conditions":76,"keywords":19,"overallStatus":81,"whyStopped":19,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Myeloid Therapeutics","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CRT-402","EXPERIMENTAL","Participants will receive CRT-402 by intravenous infusion. Dose escalation will proceed according to protocol-defined safety criteria.",[13],"Drug: CRT-402",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","CRT-402 administered by intravenous infusion.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Adam Raff, MD, PhD","SVP Clinical Development, CREATE Medicines","STUDY_DIRECTOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Clinical Department","CONTACT","+1 617 465 1022","CRT402-clinical@createmedicines.com",[32],{"facility":33,"status":19,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Linear Advanced Clinical Trial Centre, Ground Floor, B Block, Queen Elizabeth II Medical Centre, Hospital Avenue","Nedlands","Western Australia","6009","Australia","AU",{"type":40,"coordinates":41},"Point",[42,43],115.8073,-31.98184,{"lat":43,"lon":42},[46,50],{"name":47,"role":28,"phone":48,"phoneExt":19,"email":49},"Prof. Merrilee Needham","+61 8 6382 5100","actcstartup@linear.org.au",{"name":51,"role":52,"phone":19,"phoneExt":19,"email":19},"Merrilee Needham","PRINCIPAL_INVESTIGATOR",{"type":54,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[56],{"name":57,"class":58},"CREATE Medicines","UNKNOWN","100652789","phase-1-a-study-to-test-crt-402-in-refractory-autoimmune-disease-100652789",false,"NCT07778446","A Study to Test CRT-402 in Refractory Autoimmune Disease","A Phase 1\u002F2 Dose Escalation and Expansion Study of CRT-402, an In Vivo CD19 Targeted CAR-T Therapy, in Refractory Autoimmune Disease","Inclusion Criteria:\n\n* Age 18 years or older.\n* Diagnosis of active, refractory systemic lupus erythematosus, systemic sclerosis, or idiopathic inflammatory myopathy meeting established classification criteria, with inadequate response or intolerance to standard therapy.\n* Adequate renal, hepatic, cardiac, and pulmonary function per protocol-defined criteria.\n* Participants of reproductive potential must agree to use protocol-specified contraception during the study and for a defined period after dosing.\n* Females of childbearing potential must have a negative pregnancy test before treatment.\n* Must be willing and able to attend study visits and follow all study requirements.\n\nExclusion Criteria:\n\n* Clinical suitability for a less burdensome and\u002For approved therapeutic approach, as judged by the Investigator,\n* Any medical condition or laboratory abnormality that, in the Investigator's judgment, would place the participant at unacceptable risk or confound interpretation of study data,\n* Prior Cluster of differentiation 19 (CD19)-directed, cell, or gene therapy,\n* History of bone marrow\u002F hematopoietic stem cell or solid organ transplantation,\n* Active or inadequately treated infection, including Human immunodeficiency (HIV), hepatitis B or C, or tuberculosis,\n* Pregnancy or lactation.","ALL","18 Years",{"count":69,"type":70},34,"ESTIMATED","INTERVENTIONAL",[73,74],"PHASE1","PHASE2","Patients with refractory autoimmune diseases often have limited treatment options and ongoing disease activity despite standard therapies. CRT-402 is an in vivo Cluster of differentiation 19 (CD19)-targeted CAR-T cell therapy designed to deplete CD19-positive B cells and promote immune system reset. This study evaluates the safety, tolerability, preliminary efficacy, pharmacodynamics (PD), and pharmacokinetics (PK) of CRT-402 in participants with active refractory systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and idiopathic inflammatory myopathies (IIM).",[77,78,79,80],"Autoimmune Diseases","Systemic Lupus Erythematosus","Systemic Scleroderma","Myositis","NOT_YET_RECRUITING","2026-08-19",{"date":84,"type":85},"2026-08-21","ACTUAL",{"date":87,"type":70},"2026-08-24",{"date":89,"type":70},"2029-08-01",{"name":5,"class":6},1]