Plate Nº 93 · recorded October 10, 2026
Health & Medicine ResearchReported finding
Updated CAR T-Cell Therapy Guidance Targets Severe Autoimmune Diseases
A panel of 31 international experts has published 2026 consensus recommendations in The Lancet Rheumatology for CAR T-cell therapy in severe, treatment-refractory autoimmune diseases.
By James Calloway3 min read646 words
In brief
- 31 international experts drafted the 2026 update, published in The Lancet Rheumatology (DOI: 10.1016/S2665-9913(26)00249-3).
- EBMT, ISCT and JACIE developed the document with contributions from EULAR and ECTRIMS, replacing 2024 best-practice recommendations.
- Guidance covers four disease groups: rheumatological, neurological, hematological and pediatric autoimmune indications.
- Raffaella Greco (Milan) and Dominique Farge (Paris) coordinated the consensus effort.
- The panel strongly recommends reporting every treated patient to the expanded EBMT Registry for long-term outcome tracking.
A panel of 31 international experts has released updated 2026 consensus recommendations for using CAR T-cell therapy in patients with severe autoimmune diseases that no longer respond to standard treatments. Published in The Lancet Rheumatology, the document updates the first best-practice recommendations issued in 2024.
What does CAR T-cell therapy actually do?
CAR T-cell therapy is a treatment in which doctors collect a patient's own immune cells, called T-cells, from the blood. Technicians modify those cells in a laboratory so they can recognize and attack disease-causing cells, then return them to the patient as an infusion. The approach produced lasting remissions in certain blood cancers and is now being tested for severe autoimmune conditions, including lupus, where the immune system attacks the body's own tissues.
Why update the 2024 guidance now?
Three organizations developed the new document jointly: EBMT (European Society for Blood and Marrow Transplantation), ISCT (International Society for Cell & Gene Therapy) and JACIE (Joint Accreditation Committee of ISCT and EBMT). EULAR and ECTRIMS, two major rheumatology and multiple sclerosis societies, also contributed representatives.
The experts used EBMT's structured practice harmonization methodology, a process designed for medical areas where high-level evidence is still emerging. Recommendations span four categories of disease:
- Rheumatological conditions
- Neurological conditions
- Hematological conditions
- Pediatric cases
Coordinators Raffaella Greco of San Raffaele Hospital in Milan and Dominique Farge of St-Louis Hospital in Paris said the field is moving quickly.
"CAR T-cell therapy is emerging as an important new therapeutic approach for patients with severe and refractory autoimmune diseases," they said. "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."
Who should receive the therapy?
The panel recommends considering CAR T-cell therapy for patients whose autoimmune disease stays active or worsens despite appropriate standard treatment. Whenever possible, treatment should take place inside a registered clinical trial. When no trial is available, a documented multidisciplinary team — including autoimmune disease specialists and hematology or cellular therapy experts — should make the decision.
The guidance directs clinicians to experienced centers. Preferred sites carry FACT or JACIE accreditation for immune effector cell therapies, ensuring consistent quality and safety.
What does the new guidance cover?
The 2026 recommendations organize care around six stages:
- Patient selection
- Diagnostic assessment before treatment
- Treatment planning
- Clinical management during and after infusion
- Follow-up
- Immune monitoring
A central concern is telling apart two events that can look similar: inflammation caused by the CAR T-cell therapy itself, and a flare of the underlying autoimmune disease. Distinguishing the two, the experts wrote, requires close collaboration between hematology, cellular therapy and autoimmune disease teams.
What about children and adolescents?
The document provides separate guidance for younger patients, for whom evidence remains especially thin. Recommendations emphasize a multidisciplinary assessment that weighs disease severity, prior treatments, organ damage, development, fertility, quality of life and the long-term effects of chronic immunosuppression.
How will long-term safety be tracked?
The panel strongly recommends reporting data on every treated patient to the EBMT Registry, which has been expanded to follow autoimmune disease patients across participating centers. Long-term outcomes, durability of response and late toxicities remain open questions. Both the U.S. Food and Drug Administration and the European Medicines Agency have recently called for systematic data collection in this area.
What research gaps remain?
The authors list four priorities for future work:
- Larger controlled clinical trials
- Biomarkers that predict response and toxicity
- Novel CAR targets
- Strategies to broaden patient access
The 2026 recommendations are designed as "living guidance" and will continue to evolve as new evidence and clinical experience emerge.
The paper carries the DOI 10.1016/S2665-9913(26)00249-3.
via Medical Xpress (Source)
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