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Study identifier: NCT06685042 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Lupus Erythematosus, Systemic · System; Sclerosis · ANCA Associated Vasculitis  ·  Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

PhasePhase 1/Phase 2
Planned participants8
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersNo

About this study

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.

Talk to the study team

Maria Antonietta D'Agostino  ·  (+39)0630159650  ·  mariaantonietta.dagostino@policlinicogemelli.it

Always discuss trial participation with your own doctor first.

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCSRome, Lazio, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT06685042