Research
Autoimmune Diseases Working Party (ADWP)
Experts from EBMT, ISCT and JACIE, with representatives from EULAR and ECTRIMS, have published updated recommendations supporting careful patient selection, multidisciplinary care and long-term follow-up as CAR T-cell therapy expands beyond cancer.
An international multidisciplinary group of 31 experts has updated consensus recommendations for using chimeric antigen receptor (CAR) T-cell therapy in people with severe, treatment-refractory autoimmune diseases.
Published in The Lancet Rheumatology, the 2026 recommendations were developed jointly by EBMT, the International Society for Cell & Gene Therapy (ISCT) and JACIE, with contributions from representatives of the European Alliance of Associations for Rheumatology (EULAR) and the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). They update the first best-practice recommendations released in 2024.
The new guidance reflects growing clinical experience with CAR T-cell therapy beyond cancer. It covers rheumatological, neurological, haematological and paediatric indications, addressing patient selection, diagnostic assessment, treatment planning, clinical management, follow-up and immune monitoring.
A shared framework for patient selection and care
The consensus recommends considering CAR T-cell therapy for patients whose severe autoimmune disease remains active or progressive despite appropriate standard treatment. Whenever possible, treatment should take place within a clinical trial.
Where a trial is unavailable, decisions should follow a documented multidisciplinary assessment involving autoimmune disease specialists and haematology or cellular therapy experts.
Treatment should be delivered in experienced centres, preferably those accredited by FACT/JACIE for immune effector cell therapies, to support consistent quality and safety standards. Disease-specific assessment and monitoring remain essential because autoimmune diseases vary considerably in organ involvement, comorbidities and previous treatments.
Although early clinical experience has shown promising results in some patients who have not responded to existing therapies, the expert panel stresses that CAR T-cell therapy in autoimmune diseases remains an evolving field. The recommendations were therefore developed using EBMT’s structured practice harmonisation methodology for areas where high-level evidence is still emerging.
Supporting safe and consistent clinical practice
“CAR T-cell therapy is emerging as an important new therapeutic approach for patients with severe and refractory autoimmune diseases. However, this remains a rapidly evolving field, and careful patient selection, multidisciplinary management and long-term follow-up are essential. These recommendations provide a shared framework to support patient safety and greater consistency in clinical practice while we continue to build the evidence base.”
Raffaella Greco, San Raffaele Hospital, Milan, and Dominique Farge, Saint-Louis Hospital, Paris, coordinators of the consensus recommendations.
The guidance places strong emphasis on care before and after CAR T-cell infusion, including diagnostic assessment, treatment planning, immune monitoring and management of treatment-related toxicities.
It also highlights the importance of distinguishing inflammatory complications associated with CAR T-cell therapy from progression or flare of the underlying autoimmune disease. This requires close collaboration among haematology, cellular therapy and autoimmune disease specialist teams.
Building the long-term evidence base
Long-term follow-up and systematic data collection are central priorities. The panel strongly recommends reporting patients treated with CAR T-cell therapies to the EBMT Registry to strengthen understanding of long-term outcomes, durability of response and late toxicities.
The registry has been expanded to support the follow-up of patients with autoimmune diseases across participating centres.
The recommendations also address children and adolescents, for whom evidence remains limited. Multidisciplinary assessments should consider disease severity, previous treatments, organ damage, development, fertility, quality of life and the long-term effects of chronic immunosuppression.
An international multidisciplinary effort
The guidance was developed through a structured international consensus process involving specialists in haematopoietic cell transplantation, CAR T-cell therapy and autoimmune diseases from multiple disciplines and countries.
The authors identify several priorities for future research, including larger controlled clinical trials, biomarkers of response and toxicity, novel CAR targets and strategies to improve access to treatment. Long-term registry data will be critical to defining the role of CAR T-cell therapy across different autoimmune diseases.
The 2026 recommendations are intended as living guidance under the auspices of EBMT, ISCT and JACIE and will continue to evolve as new evidence and clinical experience emerge.
Publication: The updated recommendations are published in The Lancet Rheumatology.