protocolSection identificationModule nctId: NCT06347718, orgStudyIdInfo id: CASTLE, secondaryIdInfos id: 2022-001366-35, type: EUDRACT_NUMBER, secondaryIdInfos id: DRKS00032279, type: REGISTRY, domain: Deutsches Register Klinischer Studien (DRKS), briefTitle: CAR-T Cells in Systemic B Cell Mediated Autoimmune Disease, acronym: CASTLE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-17, primaryCompletionDateStruct date: 2026-05-31, completionDateStruct date: 2026-05-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: University of Erlangen-Nürnberg Medical School, class: OTHER, descriptionModule briefSummary: The investigational product is designed to effectively combat B cells in patients with autoimmune diseases. Autologous T cells enriched with CD4/CD8 are genetically engineered using a lentiviral vector to express chimeric antigen receptors (CARs) that target the CD19 antigen on the cell surface of B cells and their precursors. During treatment, patients undergo leukapheresis, lymophodepleting chemotherapy and administration of the expanded CD19-CAR-transduced T cells., conditionsModule conditions: Systemic Lupus Erythematosus, conditions: Systemic Sclerosis, conditions: Dermatomyositis, conditions: Polymyositis, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Phase 1:Evaluating the safety of CAR-T-Cells in systemic autoimmune diseases with 8 patientsPhase 2:Evaluating the efficiency of CAR-T-Cells in systemic autoimmune diseases with 16 patients, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: anti-CD19 CAR T cell therapy, outcomesModule primaryOutcomes measure: To assess the safety of anti-CD19 CAR T cell therapy in subjects with active B-driven autoimmune disease (SLE, SSc and DM/PM)., secondaryOutcomes measure: Clinical efficacy SSc, secondaryOutcomes measure: Clinical efficacy SLE, secondaryOutcomes measure: Clinical efficacy DM, secondaryOutcomes measure: Cellular response, secondaryOutcomes measure: Serological response, secondaryOutcomes measure: Success of IMP process, secondaryOutcomes measure: Physicians Global Assessment to measure quality of life, secondaryOutcomes measure: Patient's Global Assessment to measure quality of life, secondaryOutcomes measure: Health Assessment Questionnaire, secondaryOutcomes measure: Functional Assessment of Chronic Illness Therapy, secondaryOutcomes measure: SLE-specific disease activity over time per subject, secondaryOutcomes measure: SSc-specific disease activity over time per subject, secondaryOutcomes measure: DM/PM-specific disease activity over time per subject, secondaryOutcomes measure: SLE-specific disease activity over time per subject, secondaryOutcomes measure: DM/PM-specific disease activity over time per subject, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universitätsklinikum Erlangen, status: RECRUITING, city: Erlangen, state: Bavaria, zip: 91054, country: Germany, contacts name: Georg Schett, Prof. Dr., role: CONTACT, contacts name: Daniela Bohr, Dr., role: CONTACT, geoPoint lat: 49.59099, lon: 11.00783, hasResults: False