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

Korábbi kezelés

• Previous CAR-T cell therapy. viii) Significant lung impairment. ix) Inadequate organ function. x) Active, clinically significant, central nervous system (CNS) disorders.

Más betegség

• 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.

Egyéb

• 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.

• 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.