Phase 1 CAR-T Safety Study, Autoimmune Rheumatic Diseases
Summary
This ClinicalTrials.gov registry entry documents a Phase I open-label, monocenter interventional study conducted at Gustave Roussy evaluating the safety, tolerability, and preliminary efficacy of a single dose of autologous anti-CD19 CAR-T cells as an advanced therapy medicinal product. The study enrolls adult patients with severe and refractory systemic autoimmune rheumatic diseases, specifically rheumatoid arthritis, systemic lupus erythematosus, Sjogren's disease, systemic sclerosis, and idiopathic inflammatory myositis. No compliance obligations or deadlines are created by this registry entry.
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What changed
The ClinicalTrials.gov record registers a Phase I interventional study (NCT07544225) investigating autologous anti-CD19 CAR-T cells for five severe autoimmune rheumatic indications: rheumatoid arthritis, systemic lupus erythematosus, Sjogren's disease, systemic sclerosis, and idiopathic inflammatory myositis. The study is open-label, single-dose, and monocenter, conducted at Gustave Roussy in France. This registry entry is informational and creates no compliance obligations for regulated entities.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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
Phase 1 NCT07544225 Kind: PHASE1 Apr 22, 2026
Abstract
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).
Conditions: Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Sjogren's Disease With Dry Eyes, Systemic Sclerosis (SSc), Idiopathic Inflammatory Myositis (IIM)
Interventions: anti-CD19 CAR-T cells
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