Anti-CD 19 CAR-T Cell Therapy in Patients With ANCA Vasculitis

Inclusion Criteria: * Understand and voluntarily sign an informed consent form * Male or female, age ≥ 18 and ≤ 75 years at ti me of consent * Able to adhere to the study visits and protocol * Fulfilment of * EITHER both of the following * 2022 ACR-EULAR classification criteria for granulomatosis with polyangiitis (GPA) * detectable anti-PR3 antibodies (≥ 20 AU/ml in CLIA) at screening * OR both of the following * 2022 ACR/EULAR classification criteria for microscopic polyangiitis (MPA) * detectable anti-MPO antibodies (≥ 10 AU/ml in CLIA) at screening * Active disease, defined as Clinical activity (BVAS ≥ 3) at screening * Insufficient response or intolerance/contraindication to glucocorticoids and to at least one of the following treatments: rituximab, mycophenolate mofetil, azathioprine, methotrexate, cyclophosphamide, avacopan. Insufficient response is defined as having disease activity based on the definition explained in the previous bullet point * Male subjects unless surgically sterile, must agree to use two acceptable 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 * Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening and must agree to use a highly effective contraceptive method (Pearl index less than 1) starting from the time of signing the ICF and f…