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)
Novartis Pharmaceuticals
123 participants
Dec 17, 2024
INTERVENTIONAL
Conditions
Summary
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)
Eligibility
Inclusion Criteria4
- 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
- Participant must meet criteria for severe myositis
Exclusion Criteria7
- 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
- BMI at Screening of ≤17 or ≥40 kg/m2
- Severe muscle damage at Screening
- Inadequate organ function
- Hypersensitivity and/or contraindications to any product (including its ingredients) to be given to the participant as per the study protocol
- Other inflammatory and non-inflammatory myopathies
- Any medical conditions that are not related to IIM that would jeopardize the ability of the participant to tolerate CD19 CAR-T cell therapy
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Interventions
Single infusion of rapcabtagene autoleucel after lymphodepleting therapy with fludarabine (adjusted based on renal impairment) and cyclophosphamide daily for 3 days.
Investigator choice of treatment as per protocol
Locations(55)
View Full Details on ClinicalTrials.gov
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NCT06665256