[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06328777":3,"trial-entities:NCT06328777":262,"trial-summary:NCT06328777":266},{"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":22,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":34,"interventions":37,"primary_outcomes":50,"secondary_outcomes":59,"sex":77,"minimum_age":78,"maximum_age":79,"healthy_volunteers":80,"eligibility_criteria":81,"std_ages":97,"locations":100,"central_contacts":251,"overall_officials":256,"references":260,"see_also_links":261},"NCT06328777","CAB-201-003","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","RECRUITING","2029-07","2026-08","2026-08-17","2024-07-02","Cabaletta Bio","INDUSTRY",null,"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","Systemic sclerosis (SSc), also known as scleroderma , is a rare autoimmune disorder characterized by autoantibody production and abnormal B cell function. Though the cause of SSc is not well understood, it is thought to involve B cells that cause the body to attack different tissues in one's own body, causing skin and organ fibrosis. This study is being conducted to evaluate the safety and efficacy of an investigational therapy, CABA-201, a CD19-CAR T cell therapy, that can be given to patients with SSc who have active disease. A single dose of CABA-201 in combination with cyclophosphamide (CY) and fludarabine (FLU) will be evaluated.",[19,20,21],"Systemic Sclerosis","Scleroderma","Interstitial Lung Diseases",[23,24,25,26,27,28],"CABA-201","autoimmune disease","anti-CD19 CAR-T therapy","systemic sclerosis","scleroderma","Interstitial lung disease","INTERVENTIONAL","TREATMENT",[32,33],"PHASE2","PHASE3",{"count":35,"type":36},37,"ESTIMATED",[38,46],{"type":39,"name":23,"description":40,"armGroupLabels":41,"otherNames":43},"BIOLOGICAL","Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide",[42],"CABA-201 Phase 1\u002F2",[44,45],"Rese-cel","Resecabtagene autoleucel",{"type":39,"name":23,"description":40,"armGroupLabels":47,"otherNames":49},[48],"CABA-201 Phase 2b - Sub-study",[44,45],[51,55],{"measure":52,"description":53,"timeFrame":54},"Phase 1\u002F2: To evaluate incidence of adverse events","Incidence and severity of AEs","Up to 28 days after CABA-201 infusion",{"measure":56,"description":57,"timeFrame":58},"Phase 2b Sub-study: To evaluate the efficacy of CABA-201 on % predicted forced vital capacity (FVC) in SSc-ILD subjects","Mean change from baseline in % predicted FVC without any immunomodulatory or anti-fibrotic medications and on no or low dose of steroids","Week 52",[60,64,67,70,74],{"measure":61,"description":62,"timeFrame":63},"To evaluate 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 104 weeks (Sub-study)",{"measure":65,"description":66,"timeFrame":63},"To characterize the pharmacodynamics (PD)","Levels of B cells in the blood",{"measure":68,"description":69,"timeFrame":63},"To characterize the pharmacokinetics (PK)","Levels of CABA-201-positive T cells in the blood",{"measure":71,"description":72,"timeFrame":73},"To evaluate efficacy","Proportion of subjects achieving revised Composite Response Index for Systemic Sclerosis (CRISS) criteria","Up to 156 weeks (Phase 1\u002F2) and at Week 52 (Sub-study)",{"measure":75,"timeFrame":76},"Mean change from baseline in Modified Rodnan Skin Score (mRSS)","Week 52 (Sub-study)","ALL","18 Years","75 Years",false,{"inclusion":82,"exclusion":87,"raw_text":96},[83,84,85,86],"Age ≥18 and ≤75","A clinical diagnosis of SSc, based on the 2013 American College of Rheumatology and European League Against Rheumatism classification criteria.","Early active disease","Evidence of significant skin, pulmonary, or cardiac involvement",[88,89,90,91,92,93,94,95],"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 visit","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","Severe lung or cardiac impairment","Previous CAR T cell therapy","Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant","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, 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.",[98,99],"ADULT","OLDER_ADULT",[101,119,134,149,160,175,191,205,219,232],{"facility":102,"status":8,"city":103,"state":104,"zip":105,"country":106,"contacts":107,"geoPoint":116},"Yale University","New Haven","Connecticut","06519","United States",[108,113],{"name":109,"role":110,"phone":111,"email":112},"Stephanie Perez","CONTACT","860-992-2908","s.perez@yale.edu",{"name":114,"role":115},"Dr. Monique Hinchcliff, MD, MS","PRINCIPAL_INVESTIGATOR",{"lat":117,"lon":118},41.30815,-72.92816,{"facility":120,"status":8,"city":121,"state":122,"zip":123,"country":106,"contacts":124,"geoPoint":131},"Mayo Clinic Florida","Jacksonville","Florida","55905",[125,129],{"name":126,"role":110,"phone":127,"email":128},"Gabrielle Pariseau","904-953-5549","Pariseau.Gabrielle@mayo.edu",{"name":130,"role":115},"Dr. Andy Abril, MD",{"lat":132,"lon":133},30.33218,-81.65565,{"facility":135,"status":8,"city":136,"state":137,"zip":138,"country":106,"contacts":139,"geoPoint":146},"Northwestern Memorial Hospital","Chicago","Illinois","60611",[140,144],{"name":141,"role":110,"phone":142,"email":143},"Kaitlin King","312-695-0990","autoimmunesct@nm.org",{"name":145,"role":115},"Dr. George Georges, MD",{"lat":147,"lon":148},41.85003,-87.65005,{"facility":150,"status":8,"city":136,"state":137,"zip":151,"country":106,"contacts":152,"geoPoint":159},"The University of Chicago Medical Center","60637",[153,157],{"name":154,"role":110,"phone":155,"email":156},"Dequana Jones","773-834-5726","Dequana.Jones@bsd.uchicago.edu",{"name":158,"role":115},"Dr. Michael Macklin, MD",{"lat":147,"lon":148},{"facility":161,"status":8,"city":162,"state":163,"zip":164,"country":106,"contacts":165,"geoPoint":172},"University of Kansas Medical Center","Kansas City","Kansas","66160",[166,170],{"name":167,"role":110,"phone":168,"email":169},"Theresa Howard","913-588-0653","Thoward2@kumc.edu",{"name":171,"role":115},"Dr. Paul Schmidt, MD",{"lat":173,"lon":174},39.11417,-94.62746,{"facility":176,"status":8,"city":177,"state":178,"zip":179,"country":106,"contacts":180,"geoPoint":188},"University of Michigan","Ann Arbor","Michigan","48109",[181,184,186],{"name":182,"role":110,"email":183},"Lynne Bischoff","lloisros@med.umich.edu",{"role":110,"email":185},"ssc-coordinator@umich.edu",{"name":187,"role":115},"Monalisa Ghosh, MD",{"lat":189,"lon":190},42.27756,-83.74088,{"facility":192,"status":8,"city":193,"state":194,"zip":123,"country":106,"contacts":195,"geoPoint":202},"Mayo Clinic Rochester","Rochester","Minnesota",[196,200],{"name":197,"role":110,"phone":198,"email":199},"Christi Sagen","507-422-3425","sagen.christine@mayo.edu",{"name":201,"role":115},"Ashima Makol, MD",{"lat":203,"lon":204},44.02163,-92.4699,{"facility":206,"status":8,"city":207,"state":207,"zip":208,"country":106,"contacts":209,"geoPoint":216},"Columbia University Irving Medical Center","New York","10032",[210,214],{"name":211,"role":110,"phone":212,"email":213},"Gaby Ycaza","212-342-2751","mgy2107@cumc.columbia.edu",{"name":215,"role":115},"Elana Bernstein, MD",{"lat":217,"lon":218},40.71427,-74.00597,{"facility":220,"status":8,"city":193,"state":207,"zip":221,"country":106,"contacts":222,"geoPoint":229},"University of Rochester","14642",[223,227],{"name":224,"role":110,"phone":225,"email":226},"Chelsey LoMonaco","585-402-2916","Chelsey_lomonaco@urmc.rochester.edu",{"name":228,"role":115},"Benjamin Korman, M.D.",{"lat":230,"lon":231},43.15478,-77.61556,{"facility":233,"status":8,"city":234,"state":235,"zip":236,"country":106,"contacts":237,"geoPoint":248},"Duke University","Durham","North Carolina","27710",[238,242,246],{"name":239,"role":110,"phone":240,"email":241},"Khalia Stewart","919-660-2280","Khalia.stewart@duke.edu",{"name":243,"role":110,"phone":244,"email":245},"Michelle Mack","919-613-1107","Michelle.mack@duke.edu",{"name":247,"role":115},"Ankoor Shah, MD",{"lat":249,"lon":250},35.99403,-78.89862,[252],{"name":13,"role":110,"phone":253,"phoneExt":254,"email":255},"267 759 3100","4444","clinicaltrials@cabalettabio.com",[257],{"name":258,"affiliation":13,"role":259},"Medical Director","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":263,"biomarkers":265},[264],"Systemic Scleroderma",[],{"nct_id":4,"found":267,"summary":268,"prompt_version":278},true,{"design":269,"status":270,"heading":271,"summary":272,"follow_up":273,"word_count":274,"commitments":275,"compensation":276,"drugs_mentioned":277},"This is an open-label study, meaning you and your doctors will know what treatment you are receiving. It plans to enroll 12 participants.","completed","RESET-SSc: CABA-201 for Systemic Sclerosis","This study, called RESET-SSc, is testing a new treatment called CABA-201 for people with systemic sclerosis (scleroderma). Scleroderma is a rare condition where your body's immune system attacks its own tissues, causing scarring in the skin and organs. CABA-201 is a type of CAR T cell therapy, which means it uses your own immune cells, specially modified, to target certain cells in your body. Researchers believe that CABA-201, given as a single infusion after some other medications (fludarabine and cyclophosphamide), might help by targeting specific immune cells (B cells) that are thought to cause scleroderma. This study aims to see how safe CABA-201 is and if it helps improve the condition. It is looking for about 12 participants between 18 and 75 years old who have active scleroderma affecting their skin or organs. The study's status is currently unclear regarding recruitment.","The study will evaluate side effects for up to 28 days after you receive the CABA-201 infusion.",141,"Not specified in the trial record.","Not stated in the trial record.",[23],"v2"]