Badanie 1 fazy z zastosowaniem pochodzących od zdrowego dawcy allogenicznych limfocytów CAR T ukierunkowanych na antygen CD19 u uczestników z ciężkimi, opornymi na leczenie chorobami autoimmunologicznymi

Kryteria włączenia kto może wziąć udział (11)

1. - Systemic lupus erythematosus (SLE) population:.
2. i) Diagnosis of SLE based on the 2019 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR).
3. ii) 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.
4. iii) Inadequate response or intolerance to steroids and immunosuppressive therapies.
5. iv) Participants must have active disease at screening. - Inflammatory myopathy (IIM) population:.
6. i) Participants meeting the 2017 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria.
7. ii) Participants must meet criteria for with severe, refractory IIM. iii) Participants who had inadequate response to steroids and prior immunosuppressive therapies.
8. iv) Evidence of active disease. - Systemic sclerosis (SSc) population:.
9. i) Participant must fulfill the 2013 American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) classification criteria for systemic sclerosis.
10. ii) 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:.
11. i) 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.