Researchers have found that CD19 chimeric antigen receptor (CAR) T-cell therapy may be safe and effective in patients with autoimmune diseases, according to the findings of a recent case series published by Müller et al in The New England Journal of Medicine. The researchers assigned eight patients with systemic lupus erythematosus, four patients with systemic sclerosis, and three patients with idiopathic inflammatory myositis to receive one infusion of CD19 CAR T cells following preconditioning with fludarabine and cyclophosphamide. After a median follow-up of 15 months, all of the patients with lupus achieved remission according to the Definition of Remission in Systemic Lupus Erythematosus remission criteria; all of the patients with systemic sclerosis experienced reductions in their European Scleroderma Trials and Research Group activity index; and all of the patients with idiopathic inflammatory myositis demonstrated American College of Rheumatology–European League Against Rheumatism major clinical responses. The researchers noted that all of the patients involved in the case series ceased use of immunosuppressive therapy. They further reported that 10 patients experienced grade 1 cytokine-release syndrome, 1 patient experienced grade 2 cytokine-release syndrome, 1 patient experienced grade 1 immune effector cell–associated neurotoxicity, and 1 patient experienced pneumonia-related hospitalization. The researchers concluded, “In this case series, CD19 CAR T-cell transfer appeared to be feasible, safe, and efficacious in three different autoimmune diseases, providing rationale for further controlled clinical trials.”
March 14, 2024