Anti-CD19 CAR T-Cell Therapy in Refractory Systemic Autoimmune Diseases

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.

NCT Number	NCT06685042
Lead Sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions	Lupus Erythematosus, Systemic, System; Sclerosis, ANCA Associated Vasculitis, Dermatomyositis, Polymyositis
Enrollment	8 participants
Start Date	2024-11-29
Primary Completion	2025-12 (estimated)
Study Completion	2025-12 (estimated)
Updated on ClinicalTrials.gov	2025-04-11