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CATARSIS: Anti-CD19 CAR T-Cell Therapy in Refractory Systemic Autoimmune Diseases
NCT06685042Phase 2Recruiting
- Sponsor
- Policlinico Gemelli
- Start
- Nov 2024
- Primary completion
- Dec 2025
- Modality
- Gene Editing, Gene Silencing, CAR-T Cells
- Countries
- 1
01
Overview
Phase 2, open-label, single-arm trial of CD19-CAR_Lenti T cell in systemic lupus erythematosus (SLE), systemic sclerosis (SSc), dermatomyositis (DM) and 2 more, sponsored by Policlinico Gemelli. Primary endpoints: Incidence and grading of severity of Cytokine Release Syndrome (CRS) and CAR T cell Associated Neurotoxicity Syndrome (ICANS) at 4 weeks, Incidence of infections, leukopenia and/or hypogammaglobulinemia at 24 weeks and 1 more. Started Nov 2024; status: recruiting.
02
Drugs
CD19-CAR_Lenti T cell
03
Conditions
systemic lupus erythematosus (SLE)systemic sclerosis (SSc)dermatomyositis (DM)polymyositis (PM)Antineutrophil cytoplasmic antibody-associated vasculitis (AAV)
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