Condition: Lupus Erythematosus, Systemic · System; Sclerosis · ANCA Associated Vasculitis · Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.
This description comes directly from the study's public registry record.
Maria Antonietta D'Agostino · (+39)0630159650 · mariaantonietta.dagostino@policlinicogemelli.it
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| Fondazione Policlinico Universitario A. Gemelli IRCCS | Rome, Lazio, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06685042