Comparison of B-cell Depletion by Rituximab and Anti-CD 19 CAR-T Therapy in Patients With Rheumatoid Arthritis

Main Inclusion Criteria: * Understand and voluntarily sign an informed consent form * Male or female, age ≥ 18 and ≤ 80 years at time of consent * Able to adhere to the study visits and protocol * Fulfilment of the 2010 ACR-EULAR RA classification criteria * ACPA positivity (cut off 20 mU/ml) at screening * Disease Activity Score DAS28-ESR\>3.2 at screening * Failure (defined as inadequate response after at least 3 months of therapy) of at least one conventional DMARD and at least two tsDMARD/bDMARDs * At least one swollen joint with Power Doppler activity of at least grade 1 or B-mode activity of at least grade 2 at screening * Willingness to participate in a synovial puncture and biopsy * Male subjects unless surgically sterile, must agree to use two accepta-ble methods for contraception (e.g. spermicide and condom) during the trial and refrain from fathering a child starting from the time of signing the Informed Consent Form (ICF) until 12 months after dosing of the IMP or rituximab * Females of childbearing potential (FCBP) must have a negative serum pregnancy test at screening and must agree to use a highly effective contraceptive method (Pearl index \<1) starting from the time of signing the ICF and for 12 months after dosing of the IMP or rituximab * Updated vaccination record according to the STIKO recommendations for immunocompromised patients Main Exclusion Criteria: * ANC \< 1.000/mm3, ALC \< 500/mm3 or hemoglobin \< 8g/dl, absolute CD3+T cell count \< 100/µl * …