Overview
This is a Phase 2, two-year, randomized, assessor- blinded, active-controlled study. This study comprises two cohorts:
* A lead-in cohort enrolling participants to receive rapcabtagene autoleucel
* A randomized cohort with participants receiving either rapcabtagene autoleucel or a comparator option.
After end of study (EOS), participants who received rapcabtagene autoleucel infusion will enter a long-term follow-up (LTFU) period lasting up to 15 years after rapcabtagene autoleucel infusion. This LTFU will be described in a separate study protocol.
Principal investigator
Eligibility criteria
Key Inclusion Criteria:
1. Men and women, aged \>18 and ≤65 years, with a diagnosis of probable or definite myositis according to American College of Rheumatology/European League Against Rheumatism 2017 (ACR/EULAR 2017) criteria
2. Participants who had inadequate response to prior therapy
3. Diagnosed with active disease
4. Participant must meet criteria for severe myositis
Key Exclusion Criteria: 1. 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 2. BMI at Screening of ≤18.5 or ≥35 kg/m2 3. Severe muscle damage at Screening 4. Inadequate organ function 5. Hypersensitivity and/or contraindications to any product (including its ingredients) to be given to the participant as per the study protocol 6. Other inflammatory and non-inflammatory myopathies 7. 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.
Key Exclusion Criteria: 1. 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 2. BMI at Screening of ≤18.5 or ≥35 kg/m2 3. Severe muscle damage at Screening 4. Inadequate organ function 5. Hypersensitivity and/or contraindications to any product (including its ingredients) to be given to the participant as per the study protocol 6. Other inflammatory and non-inflammatory myopathies 7. 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.
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