Status: Not yet recruiting
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).
Participants needed: 6
Trial details
Phase: Phase 1Age: 18-75Biological sex: AllType: InterventionalSponsor: Gustave Roussy, Cancer Campus, Grand ParisUpdated: Sep 2, 2026Locations: 1
Eligibility criteria
Patients ≥ 18 and ≤ 75 years of age at the time of inclusion visit. [+42]
Active hepatitis B (defined by detectable HBV DNA) or C infection (defined by de... [+17]