Phase 2 Study of Rapcabtagene Autoleucel in Myositis

Ki vehet részt

• Men and women, aged ≥ 18 and ≤75 years, with a diagnosis of probable or definite myositis according to American College of Rheumatology/European League Against Rheumatism 2017 (ACR/EULAR 2017) criteria
• Participants who had inadequate response to prior therapy
• 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
• Participant must meet criteria for severe myositis such as presence of active muscle weakness

Ki nem vehet részt

• 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
• Hypersensitivity and/or contraindications to any product (including its ingredients) to be given to the participant as per the study protocol
• Any medical conditions that are not related to IIM that would jeopardize the ability of the participant to tolerate CD19 CAR-T cell therapy; Other protocol-defined inclusion/exclusion criteria may apply
• BMI at Screening of ≤17 or ≥40 kg/m2
• Severe muscle damage at Screening
• Inadequate organ function
• Other inflammatory and non-inflammatory myopathies