Anti-CD19 CAR T-Cell TherApy in Refractory Systemic Autoimmune DISeases - CATARSIS

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• Subjects having any of the following criteria at screening will not be included in the study: - Clinically suitability for a less burdensome and/or approved therapeutic approach, as judged by the investigator; - ANC < 1.000/mm3, ALC < 500/mm3 or hemoglobin < 8 g/dl, absolute CD3+ T cell count ≤100/μl; - Evidence of significant and uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results. - Relevant cardiovascular disease: recent history of myocardial infarction, cardiac angioplasty or stenting, unstable angina, significant arrhythmia, congestive heart failure or left ventricular ejection fraction < 50%, as determined by echocardiography - Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she was to participate in the study or confounds the ability to interpret data from the study; - Impaired renal function, i.e., eGFR < 30 ml/min; - Patients with evidence on thorax CT of advanced fibrotic interstitial lung disease and whose latest pulmonary function test showed a Forced Vital Capacity (FVC) < 40% of predicted or a Diffusing Capacity for Carbon Monoxide (DLCO) < 30% of predicted - Any concomitant severe active infection, including, HIV (even with negative viral load), active hepatitis B (either positive for Hepatitis B core antibody [HBcAb] or positive hepatitis B surface antigen [HBsAg] and NAT tests) and/or C (<12 weeks between achievement of a sustained virological response to the specific treatment and apheresis) according to the American Association for the Study of Liver Diseases guidelines, SARS-CoV 2 (COVID 19), or active tuberculosis as defined by a positive Quantiferon TB-test. If presence of latent tuberculosis is established then treatment according to local guidelines must have been initiated prior to enrolment; - Pregnant or lactating females; - Known hypersensitivity to either any drug components or any auxiliary medicinal products scheduled during trial participation, including during lymphodepletion;; - Malignancy in the last 5 years before screening.The inclusion of patients with previously completely resected carcinoma in situ who have not required treatment other than surgery is allowed. - Previous CAR T cell administration; - A therapeutic schedule not compatible with the wash-out requirements for the leukapheresis procedure (section 5.8.1) and the medications permitted during the study (section 7.11); - Concurrent treatment with other investigational agents or participation in other investigational trials. - Treatment, as part of an investigational clinical trial, with an experimental product with definite or potential effect on T or B-cells in the previous 2 years. - Requirement for immunization with live vaccine during the study period or within 14 days preceding leukapheresis; - Subjects who are younger than 18 years or are incapable to understand the aim, importance and consequences of the study and to give legal informed consent; - Have a history of alcohol or substance abuse within the preceding 6 months that, in the opinion of the Investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results; - Subjects who possibly are dependent on the Sponsor, the Principal Investigator or Investigator (e.g., family members)