[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06665256":3,"trial-entities:NCT06665256":523,"trial-summary:NCT06665256":528},{"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":20,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":49,"secondary_outcomes":54,"sex":68,"minimum_age":69,"maximum_age":70,"healthy_volunteers":71,"eligibility_criteria":72,"std_ages":76,"locations":79,"central_contacts":517,"overall_officials":518,"references":521,"see_also_links":522},"NCT06665256","CYTB323L12201","Phase 2 Study of Rapcabtagene Autoleucel in Myositis","A Phase 2, Randomized, Open-label, Controlled Study to Evaluate the Efficacy and Safety of Rapcabtagene Autoleucel Versus Comparator in Participants With Severe Refractory Idiopathic Inflammatory Myopathies (IIM)","ACTIVE_NOT_RECRUITING","2032-11-29","2026-06","2026-06-23","2024-12-17","Novartis Pharmaceuticals","INDUSTRY",true,"A Phase 2, randomized, open-label, controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe refractory idiopathic inflammatory myopathies (IIM)","This is a Phase 2, randomized, active-controlled study. This study comprises two cohorts:\n\n* A lead-in cohort enrolling participants to receive rapcabtagene autoleucel\n* A randomized cohort with participants receiving either rapcabtagene autoleucel or a comparator option.\n\nParticipants in the comparator arm whose signs and symptoms are not fully controlled may receive rapcabtagene autoleucel treatment once the participant is confirmed to be eligible\n\nAfter end of study (EOS), participants who received rapcabtagene autoleucel infusion will enter a long-term follow-up (LTFU) period after rapcabtagene autoleucel infusion. This LTFU will be described in a separate study protocol.",[19],"Idiopathic Inflammatory Myopathies",[21,22,23,24,25,26,27],"Chimeric Antigen Receptor T cells (CAR-T)","rapcabtagene autoleucel","idiopathic inflammatory myopathies (IIM)","dermatomyositis","Anti-Synthetase Syndrome","Immune-Mediated Necrotizing Myopathy","Interstitial Lung Disease","INTERVENTIONAL","TREATMENT",[31],"PHASE2",{"count":33,"type":34},21,"ACTUAL",[36,43],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"BIOLOGICAL","Rapcabtagene autoleucel","Single infusion of rapcabtagene autoleucel after lymphodepleting therapy with fludarabine (adjusted based on renal impairment) and cyclophosphamide daily for 3 days.",[38],[42],"YTB323",{"type":44,"name":45,"description":46,"armGroupLabels":47},"OTHER","Active Comparator Option","Investigator choice of treatment as per protocol",[48],"Comparator",[50],{"measure":51,"description":52,"timeFrame":53},"Proportion of participants achieving moderate- to-major improvement in Total Improvement Score (TIS) at Week 52","The percentage of participants with a TIS of at least 40 at the 52nd week after the start of the study, corresponding to moderate-to-major improvement.","Week 52",[55,58,62,65],{"measure":56,"description":57,"timeFrame":53},"Adjusted annual cumulative glucocorticoid dose up to Week 52","The total amount of glucocorticoids administered over the course of a year measured up to the 52nd week of treatment.",{"measure":59,"description":60,"timeFrame":61},"Change from baseline in percent predicted Forced Vital Capacity (FVC%) at Week 52","The difference in the percentage of the predicted Forced Vital Capacity (FVC) from the start of the study to the 52nd week.","Baseline, Week 52",{"measure":63,"description":64,"timeFrame":53},"Proportion of participants achieving major improvement in TIS at Week 52","The percentage of participants with a TIS of at least 60 at the 52nd week after the start of the study, corresponding to at least major improvement.",{"measure":66,"description":67,"timeFrame":61},"Change from baseline in Patient-Reported-Outcome Measurement Information System (PROMIS)-Fatigue 7a at Week 52","The difference in the fatigue levels reported by participants from the start of the study to the 52nd week.","ALL","18 Years","75 Years",false,{"inclusion":73,"exclusion":74,"raw_text":75},[],[],"Key Inclusion Criteria:\n\n1. Men and women, aged ≥ 18 and ≤75 years, with a diagnosis of probable or definite myositis according to American College of Rheumatology\u002FEuropean League Against Rheumatism 2017 (ACR\u002FEULAR 2017) criteria\n2. Participants who had inadequate response to prior therapy\n3. Diagnosed with active disease such as presence of at least 1 of the following criteria: abnormal enzyme levels assessed as secondary to IIM, or EMG demonstrating active disease, DM skin rash, muscle biopsy demonstrating active IIM, or MRI demonstrating active inflammation.\n4. Participant must meet criteria for severe myositis such as presence of active muscle weakness.\n\nKey Exclusion Criteria:\n\n1. Any condition during Screening that could prevent a complete washout of medications or could otherwise make the participant ineligible for anti-CD19 CAR-T therapy and further participation in the study\n2. BMI at Screening of ≤17 or ≥40 kg\u002Fm2\n3. Severe muscle damage at Screening\n4. Inadequate organ function\n5. Hypersensitivity and\u002For contraindications to any product (including its ingredients) to be given to the participant as per the study protocol\n6. Other inflammatory and non-inflammatory myopathies\n7. Any medical conditions that are not related to IIM that would jeopardize the ability of the participant to tolerate CD19 CAR-T cell therapy\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.",[77,78],"ADULT","OLDER_ADULT",[80,89,97,105,113,121,129,137,145,152,160,169,177,182,185,192,198,204,210,216,222,230,237,244,250,256,262,268,274,281,287,293,301,308,315,322,328,335,343,350,357,364,371,375,377,380,386,392,398,406,413,419,422,425,430,437,444,450,456,462,465,471,477,484,491,497,503,511],{"facility":81,"city":82,"state":83,"zip":84,"country":85,"geoPoint":86},"University Of Alabama","Birmingham","Alabama","35294","United States",{"lat":87,"lon":88},33.52066,-86.80249,{"facility":90,"city":91,"state":92,"zip":93,"country":85,"geoPoint":94},"FL Medical Clinic Orlando Health","Zephyrhills","Florida","33542",{"lat":95,"lon":96},28.23362,-82.18119,{"facility":98,"city":99,"state":100,"zip":101,"country":85,"geoPoint":102},"Augusta University 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Myopathy",[],{"nct_id":4,"found":15,"summary":529,"prompt_version":539},{"design":530,"status":531,"heading":532,"summary":533,"follow_up":534,"word_count":535,"commitments":536,"compensation":537,"drugs_mentioned":538},"This is a Phase 2, randomized, open-label study with an active comparator, meaning some participants will receive the study treatment and others will receive a standard treatment. The study plans to enroll 21 participants.","completed","Phase 2 Study of Rapcabtagene Autoleucel for Myositis","This study is testing a treatment called rapcabtagene autoleucel for people with severe idiopathic inflammatory myopathies (IIM), which are muscle diseases. Rapcabtagene autoleucel is a type of CAR-T therapy, which uses your own modified immune cells to fight the disease. You might receive a single infusion of rapcabtagene autoleucel after some preparation therapy, or your doctor might choose another standard treatment. The study aims to see if rapcabtagene autoleucel can lead to a moderate-to-major improvement in your symptoms after 52 weeks. You can join if you are 18 to 75 years old, have a confirmed diagnosis of myositis, and haven't responded well to previous treatments. The study plans to enroll 21 participants, but its current recruitment status is unclear.","If you receive rapcabtagene autoleucel, you will enter a long-term follow-up period after the study ends.",119,"Not specified in the trial record.","Not stated in the trial record.",[38],"v2"]