[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Cabaletta Bio\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":145},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,57,93,121],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":36,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100527937","phase-2-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-100527937",false,"NCT06154252","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","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.","ALL","6 Years","75 Years",{"count":20,"type":21},74,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","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",[28,29,30,31,32,33,34,35],"Idiopathic Inflammatory Myopathy","Dermatomyositis","Anti-Synthetase Syndrome","Immune-Mediated Necrotizing Myopathy","Juvenile Dermatomyositis","Juvenile Polymyositis","Juvenile Idiopathic Inflammatory Myopathy (JIIM)","Juvenile Myositis",[37,38,39,40,28,41,29,42,43,32,33,34,35],"CABA-201","Autoimmune Disease","Anti-CD19 CAR-T therapy","Cellular Therapy","Myositis","Anti-synthetase Syndrome","Immune-mediated Necrotizing Myopathy","RECRUITING","2026-06-08",{"date":47,"type":48},"2026-06-10","ACTUAL",{"date":50,"type":48},"2023-12-20",{"date":52,"type":21},"2028-07",{"name":54,"class":55},"Cabaletta Bio","INDUSTRY",35,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":16,"minAge":64,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":22,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},"100394964","phase-1-a-phase-12-open-label-safety-and-dosing-study-of-autologous-cart-cells-desmoglein-3-chimeric-autoantibody-receptor-t-cells-dsg3-caart-or-cd19-specific-chimeric-antigen-receptor-t-cells-caba-201-in-subjects-with-active-pemphigus-vulgaris-reset-pv-100394964","NCT04422912","A Phase 1\u002F2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA-201]) in Subjects With Active, Pemphigus Vulgaris (RESET-PV)","A Phase 1\u002F2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA-201]) in Subjects With Active, Pemphigus Vulgaris","Inclusion Criteria for DSG3-CAART: Closed to enrollment\n\n* Confirmed diagnosis of mPV by prior or screening biopsy and prior positive anti- DSG3 antibody ELISA\n* mPV inadequately managed by at least one standard immunosuppressive therapies\n* Active mPV at screening\n* Anti-DSG3 antibody ELISA positive at screening\n\nInclusion Criteria for CABA-201 sub-study: Open to enrollment\n\n* Age ≥18\n* Confirmed diagnosis of PV by prior or screening biopsy and prior positive DSG3 ELISA, IIF, and\u002For DIF\n* PV inadequately managed by at least one standard immunosuppressive therapy\n* Active PV at screening\n* DSG3 ELISA positive at screening\n\nExclusion Criteria:\n\n* Active cutaneous lesions associated with PV that indicates mucocutaneous rather than mucosal-dominant disease\n* Rituximab in last 12 months unless PV symptoms have recently worsened or anti-DSG3 antibody titers have recently increased\n* Prednisone \\> 0.25mg\u002Fkg\u002Fday\n* Other autoimmune disorder requiring immunosuppressive therapies\n* Investigational treatment in last 3 months\n\nExclusion Criteria for CABA-201 sub-study\n\n* Have paraneoplastic pemphigus or active malignancy (not including non-melanoma skin cancer) or malignancy diagnosed within the previous 5 years\n* Have received rituximab or other anti-CD20 or anti-CD19 therapies in last 12 months unless anti-DSG3 antibody titers have recently increased or PV symptoms have recently worsened\n* Prednisone \\> 0.25mg\u002Fkg\u002Fday\n* Other autoimmune disorder requiring immunosuppressive therapies\n* Treatment with any investigational agent within 4 weeks or 5 half-lives, whichever is longer.","18 Years",{"count":66,"type":21},40,[68,24],"PHASE1","A phase 1\u002F2, open-label, safety and dosing study of autologous CART cells (desmoglein 3 chimeric autoantibody receptor T cells \\[DSG3-CAART\\] or CD19-specific Chimeric Antigen Receptor T cells \\[CABA-201\\]) in subjects with active, pemphigus vulgaris",[71],"Pemphigus Vulgaris",[73,71,74,75,76,77,38,78,79,80,81,37,39,82,83],"Pemphigus","CAAR-T Therapy","CAR-T Therapy","Desmoglein 3","Cell Therapy","Autoimmunity","Skin Diseases, Vesiculobullous","Immunotherapy, Adoptive","Immune System Diseases","Resecabtagene Autoleucel","Rese-cel","2026-05-28",{"date":86,"type":48},"2026-05-29",{"date":88,"type":48},"2020-09-29",{"date":90,"type":21},"2029-01",{"name":54,"class":55},13,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":64,"maxAge":18,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":103,"conditions":104,"keywords":107,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},"100541355","phase-1-reset-ssc-an-open-label-study-to-evaluate-the-safety-and-efficacy-of-caba-201-a-cd19-car-t-cell-therapy-in-subjects-with-systemic-sclerosis-100541355","NCT06328777","RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis","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 Systemic Sclerosis","Inclusion Criteria:\n\n* Age ≥18 and ≤75\n* A clinical diagnosis of SSc, based on the 2013 American College of Rheumatology and European League Against Rheumatism classification criteria.\n* Early active disease\n* Evidence of significant skin, pulmonary, renal, or cardiac involvement\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 visit\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* Severe 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 inclusion\u002Fexclusion criteria may apply.",{"count":101,"type":21},12,[68,24],"RESET-SSc: A Phase 1\u002F2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T cell therapy, in Subjects with Systemic Sclerosis",[105,106],"Systemic Sclerosis","Scleroderma",[37,108,109,110,111],"autoimmune disease","anti-CD19 CAR-T therapy","systemic sclerosis","scleroderma","2026-05-13",{"date":114,"type":48},"2026-05-14",{"date":116,"type":48},"2024-07-02",{"date":118,"type":21},"2029-07",{"name":54,"class":55},10,{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":16,"minAge":64,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":131,"briefSummary":125,"conditions":132,"keywords":135,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},"100525404","phase-1-reset-sle-a-phase-12-open-label-study-to-evaluate-the-safety-and-efficacy-of-caba-201-in-subjects-with-active-systemic-lupus-erythematosus-100525404","NCT06121297","RESET-SLE: A Phase 1\u002F2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus","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 Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* Age ≥18 and ≤65\n* A clinical diagnosis of SLE, based on the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) classification criteria for adult SLE.\n* Positive antinuclear antibody (ANA) titer or anti-dsDNA antibody at screening.\n* For LN subjects only, active, biopsy-proven LN class III or IV, with or without the presence of class V, according to 2018 Revised International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) criteria\n* For non-renal SLE subjects only: Active, moderate to severe SLE\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* For LN subjects only: The presence of kidney disease other than active lupus nephritis\n* Previous CAR T cell therapy\n* Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant.","65 Years",{"count":130,"type":21},28,[68,24],[133,134],"Systemic Lupus Erythematosus","Lupus Nephritis",[37,38,39,40,133,134],"2026-04-07",{"date":138,"type":48},"2026-04-09",{"date":140,"type":48},"2024-02-16",{"date":142,"type":21},"2029-12",{"name":54,"class":55},23,""]