Phase 2 Study of Rapcabtagene Autoleucel in Myositis
Key facts
- Where
- Augusta, Birmingham, Chicago, Dallas, Durham, Houston, Iowa City, Pittsburgh, Salt Lake City, and Zephyrhills, United StatesSee the 10 sites
- Phase
- Phase 2
Where in United States
- Augusta University GeorgiaAugusta, United StatesNo longer taking part
- University of AlabamaBirmingham, United StatesNo longer taking part
- Northwestern UniversityChicago, United StatesNo longer taking part
- Baylor University Medical CenterDallas, United StatesNo longer taking part
- Duke Clinical Research InstituteDurham, United StatesNo longer taking part
- Houston Methodist HospitalHouston, United StatesNo longer taking part
- University of IowaIowa City, United StatesNo longer taking part
- University of Pittsburgh Medical CenterPittsburgh, United StatesNo longer taking part
- LDS HospitalSalt Lake City, United StatesNo longer taking part
- FL Medical Clinic Orlando HealthZephyrhills, United StatesNo longer taking part
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT06665256
- Record updated
- 23 June 2026
- Original description
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)Read full original descriptionShow less
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)
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)
Inclusion: 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.
Exclusion: 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.