This is an open-label, single-dose, prospective, monocenter, Phase I interventional study (not first-in-human) to assess the safety, tolerability, and preliminary efficacy of autologous anti-CD19 CAR-T cells as an advanced therapy medicinal product in adult patients; with severe and refractory systemic autoimmune rheumatic diseases, including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), Sjogren's disease (SjD), systemic sclerosis (SSc) and idiopathic inflammatory myositis (IIM).
Patients ≥ 18 and ≤ 75 years of age at the time of inclusion visit.
ECOG Performance status 0 to 2.
Signed informed consent (or legal representative) must be obtained from the patient prior to participation in the study.
Patients must have valid health insurance coverage in the country where the study is conducted.
Active hepatitis B (defined by detectable HBV DNA) or C infection (defined by detectable HCV RNA),
Known HIV infection,
Previous treatment with any gene therapy product or CAR-T cells therapy.
Inadequate organ function during screening
Single group
anti-CD19 CAR-T cells
Biological/VaccineThe anti-CD19 CAR-T cells will be administered as a single infusion at the dose of 1x106 cells/kg body weight
Unacceptable toxicities over a period of 4 weeks after the single CAR-T cell infusion
Unacceptable toxicities are defined over a period of 4 weeks after the single CAR-T cell infusion as either: * Cytokine Release Syndrome (CRS) ≥ grade 3 or, * Immune-effector Cell Associated Neurotoxicity Syndrome (ICANS) ≥ grade 3 or, * Organ toxicity (cardiac, dermatologic, gastrointestinal, hepatic, pulmonary, renal/genitourinary, or neurologic) ≥ grade 3
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