Study Investigating the Safety of Anti-CD19 CAR-T Cells Therapy Produced at Gustave Roussy for Adults With Severe and Refractory Systemic Autoimmune Rheumatic Diseases

This is an open-label, single-dose, prospective, monocenter, Phase I interventional study (not first-in-human) to assess the safety, tolerability, and preliminary efficacy of autologous anti-CD19 CAR-T cells as an advanced therapy medicinal product in adult patients; with severe and refractory systemic autoimmune rheumatic diseases, including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), Sjogren's disease (SjD), systemic sclerosis (SSc) and idiopathic inflammatory myositis (IIM).

NCT Number	NCT07544225
Lead Sponsor	Gustave Roussy, Cancer Campus, Grand Paris
Conditions	Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Sjogren's Disease With Dry Eyes, Systemic Sclerosis (SSc), Idiopathic Inflammatory Myositis (IIM)
Enrollment	6 participants
Start Date	2026-09-01
Primary Completion	2029-02-01 (estimated)
Study Completion	2043-02-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-22