Anti-CD19 CAR T-Cell Therapy in Refractory Systemic Autoimmune Diseases
Trial Parameters
Brief Summary
The CATARSIS study explores the use of anti-CD19 CAR T-cell therapy as a novel approach for treating refractory systemic autoimmune diseases, specifically SLE, SSc, DM/PM, and AAV. These life-threatening conditions often resist current therapies, and B cells play a key role in their pathogenesis. The study employs CD19-CAR\_Lenti, an autologous CAR T-cell product targeting CD19-positive B cells, aiming to reduce inflammation and autoimmunity. This open-label, single-dose, phase I basket trial will assess the safety, feasibility, and preliminary efficacy of CAR T-cell therapy, focusing on adverse events, infection rates, and overall response at 24 weeks. Eight participants will be included.
Eligibility Criteria
Inclusion criteria * General 1. Subjects must understand and voluntarily sign an informed consent form, including written consent for data protection; 2. Adults aged ≥ 18 years and \< 65 years at time of consent; 3. 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; 4. 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 \<1) starting from the time of signing the ICF and for 12 months after dosing of the IMP; 5. Must be able to adhere to the study visit schedule and other protocol requirements; 6. Double vaccination (2 doses) against SARS-CoV-2 or SARS-CoV-2 within the last 6 months. * SLE subjects a) Fulfilling the 2019 ACR/EULAR clas