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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
6
The anti-CD19 CAR-T cells will be administered as a single infusion at the dose of 1x106 cells/kg body weight
Gustave Roussy
Villejuif, Val de Marne, France
Unacceptable toxicities over a period of 4 weeks after the single CAR-T cell infusion
Unacceptable toxicities are defined over a period of 4 weeks after the single CAR-T cell infusion as either: * Cytokine Release Syndrome (CRS) ≥ grade 3 or, * Immune-effector Cell Associated Neurotoxicity Syndrome (ICANS) ≥ grade 3 or, * Organ toxicity (cardiac, dermatologic, gastrointestinal, hepatic, pulmonary, renal/genitourinary, or neurologic) ≥ grade 3
Time frame: from CAR-T cells infusion to 30 days post-treatment
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