A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases

Ki vehet részt

• Systemic lupus erythematosus (SLE) population:
• Diagnosis of SLE based on the 2019 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR)
• Participant must be positive for at least one of the following antibodies at screening: anti-nuclear antibody, anti-dsDNA, anti-histone, anti-chromatin or anti-Sm antibody
• Inadequate response or intolerance to steroids and immunosuppressive therapies
• Participants must have active disease at screening
• Inflammatory myopathy (IIM) population:
• Participants meeting the 2017 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria
• Participants must meet criteria for with severe, refractory IIM. iii) Participants who had inadequate response to steroids and prior immunosuppressive therapies
• Evidence of active disease
• Systemic sclerosis (SSc) population:
• Participant must fulfill the 2013 American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) classification criteria for systemic sclerosis
• Inadequate disease response or intolerance to prior therapies. iii) Participants diagnosed with progressive systemic sclerosis including skin disease and/or interstitial lung disease
• Rheumatoid arthritis (RA) population:
• Participants with difficult to treat RA. ii) Participants with a diagnosis of RA meeting 2010 ACR/EULAR criteria. iii) Rheumatoid arthritis disease activity at screening and baseline visit. iv) Inadequate disease response or intolerance to standard of care therapy

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• Previous CAR-T cell therapy. viii) Significant lung impairment. ix) Inadequate organ function. x) Active, clinically significant, central nervous system (CNS) disorders
• Any other systemic autoimmune disease. ii) Pregnant or nursing women. iii) Active hepatitis B, C or HIV. iv) Prior history of malignancies. v) Uncontrolled or active infection. vi) History of certain cardiovascular conditions within 6 months prior to screening
• SLE population:; Participants who have SLE because of drugs or have other autoimmune diseases along with SLE
• Rapidly deteriorating SSc, or history of severe kidney disease
• RA population:; People who have additional autoimmune diseases along with RA
• All participants:
• IIM population:; Participants who have other forms of myopathies other than IIM. ii) Severe muscle damage
• SSc population:; People who have high blood pressure in the arteries of the lungs caused by SSc, which needs regular treatment to keep it under control
• Other protocol-defined inclusion/exclusion criteria apply