Authors
8 of 11Roberto CaricchioStacie J. BellSasha BernatskyMaria Dall’EraDavid H. GoddardKENNETH C. KALUNIANAlfred H.J. KimFotios Koumpouras
Topics
CAR-T cell therapy researchBiosimilars and Bioanalytical MethodsBiomedical Ethics and RegulationBRIEF REPORTRoberto Caricchio, 1 Stacie Bell, 2 Sasha Bernatsky, 3 Maria Dall’Era, 4 David Goddard, 5 Kenneth Kalunian, 6 Alfred H. J. Kim, 7 Fotios Koumpouras, 8 Jose Rubio, 9 Amit Saxena, 10 and Saira Sheikh, 11 on behalf of the Lupus Clinical Investigators NetworkChimeric antigen receptor (CAR) T-cell therapy, long transformative in oncology, is now rapidly emerging as a fron tier in autoimmune rheumatic diseases, particularly systemic lupus erythematosus (SLE), driven by accumulating evi dence 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 clas sical toxicities (CRS, ICANS, ICAHT) and autoimmune-specific reactions such as LICATS, robust financial and resource planning, and long-term follow-up extending 15 years or more; successful implementation requires coordi nated expertise among rheumatologists, hematologist-oncologists, cellular therapy units, pharmacists, research coor dinators, and ICU-capable teams, all embedded within disciplined communication structures, harmonized SOPs, validated PROs, biorepository governance frameworks, and adherence to national and international cellular therapy standards; in parallel, investigators must anticipate bottlenecks such as apheresis access, manufacturing slot scarcity, competing trial enrollment, fluctuating SLE phenotypes, and heterogeneity-driven signal variability, while sustaining patient engagement over years through education, navigation support, and transparent risk/benefit communication; finally, collaboration with industry partners, clinical trial networks, and patient-advocacy organizations is essential for overcoming operational barriers, securing financial sustainability, and ensuring ethical stewardship, so that CAR T-cell clinical trials in autoimmunity can be executed safely, rigorously, and with maximal therapeutic promise for patients.
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PublishedNov 28, 2025
TypeArticle
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References12