A Guide for Initiating and Managing Chimeric Antigen Receptor T Cell Therapy Clinical Trials in Autoimmune Rheumatic Diseases.

ABSTRACT: Chimeric antigen receptor (CAR) T-cell therapy, long transformative in oncology, is now rapidly emerging as a frontier in autoimmune rheumatic diseases, particularly systemic lupus erythematosus (SLE), driven by accumulating evidence of deep B-cell depletion, immune "resetting," and durable drug-free remission in early studies, yet its translation into rheumatology demands mastery of formidable logistical, regulatory, clinical, and ethical complexities that span institutional readiness, multidisciplinary team formation, stringent regulatory compliance, sophisticated operational workflows, comprehensive patient selection and education, meticulous clinical management of both classical toxicities (CRS, ICANS, ICAHT) and autoimmune-specific reactions such as LICATS, robust financial and resour

SUBMITTER: Caricchio R 

PROVIDER: S-EPMC12662744 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature