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International consensus sets updated framework for CAR T-cell therapy in severe autoimmune diseases

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International consensus sets updated framework for CAR T-cell therapy in severe autoimmune diseases

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An international multidisciplinary group of 31 experts has updated consensus recommendations to guide the use of CAR T-cell therapy in patients with severe, treatment-refractory autoimmune diseases.

Published in The Lancet Rheumatology, these 2026 recommendations were developed jointly by EBMT, ISCT and JACIE, with contributions from representatives of EULAR and ECTRIMS. They update the first best-practice recommendations released in 2024.

The update reflects the rapid expansion of CAR T-cell therapy beyond cancer and growing clinical experience across autoimmune diseases. The recommendations cover rheumatological, neurological, hematological and pediatric indications and provide guidance on patient selection, diagnostic assessment, treatment planning, clinical management, follow-up and immune monitoring.

While early clinical experience has shown promising results in some patients whose disease has not responded to existing therapies, the expert panel stresses that CAR T-cell therapy remains an evolving field. The recommendations were therefore developed using EBMT's structured practice harmonization methodology, designed for areas where high-level evidence is still emerging.

The consensus recommends considering CAR T-cell therapy for patients with severe autoimmune diseases that remain active or progressive despite appropriate standard treatment. Whenever possible, treatment should be delivered within clinical trials. When trials are unavailable, decisions should be made through a documented multidisciplinary assessment involving both autoimmune disease specialists and hematology or cellular therapy experts.

The experts also recommend treatment in experienced centers, preferably FACT/JACIE-accredited for immune effector cell therapies, to ensure consistent quality and safety standards.


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