International panel updates guidelines for CAR T-cell therapy in autoimmune disease

An international panel of 31 experts published updated consensus guidelines in The Lancet Rheumatology on October 5, 2026, establishing a shared clinical framework for CAR T-cell therapy in severe autoimmune diseases. Coordinated by EBMT, ISCT, and JACIE, the guidelines address patient selection, safety, and mandatory registry reporting. The publication comes amid safety concerns in the sector following trial pauses by Novartis and Bristol Myers Squibb after three patient deaths, even as Kyverna Therapeutics prepares a 2026 BLA filing for miv-cel.

Updated international guidelines for CAR T-Cell therapy

• ▪The 2026 CAR T-cell guidelines were jointly coordinated by the EBMT, ISCT, and JACIE, with contributions from representatives of EULAR and ECTRIMS.
• ▪An international panel of 31 experts published updated consensus guidelines for CAR T-cell therapy in severe autoimmune diseases in The Lancet Rheumatology on October 5, 2026.
• ▪The updated recommendations cover patient selection, diagnostic assessment, treatment planning, management of toxicities, follow-up, and immune monitoring across rheumatological, neurological, hematological, and pediatric indications.
• ▪The updated guidelines expand CAR T-cell therapy recommendations to pediatric patients and rare hematological autoimmune diseases, including refractory immune thrombocytopenia, autoimmune hemolytic anemia, and acquired hemophilia.

Care delivery recommendations for CAR T therapy

• ▪University of Virginia associate professor Daniel Lee stated that post-therapy care for autoimmune CAR T patients must be shared collaboratively between cell therapists and home rheumatologists or neurologists.
• ▪The consensus guidelines recommend that CAR T-cell therapy for severe autoimmune disease be administered within clinical trials whenever possible.
• ▪Outside of clinical trials, the consensus panel recommends evaluating CAR T-cell candidates through documented multidisciplinary assessments involving autoimmune specialists and cellular therapy experts at accredited centers.

Mandated registry reporting for long-term outcome data

• ▪The consensus panel strongly recommends reporting all autoimmune disease patients treated with cellular therapies or hematopoietic stem cell transplantation to registries such as the EBMT Registry.
• ▪Data reporting to the EBMT Registry aims to capture long-term outcomes, toxicity profiles, and response durability to meet FDA and European Medicines Agency post-authorization requirements.

Safety setbacks in Novartis CAR T trials

• ▪The three fatal cases in Novartis' rap-cel studies were attributed to immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS).
• ▪Leerink Partners analysts stated on September 1, 2026, that serious immune-related toxicities in Novartis' rap-cel trials add considerable uncertainty to using CAR T therapies in nonfatal autoimmune conditions.
• ▪Novartis confirmed in September 2026 that it paused studies of its CAR T candidate rapcabtagene autoleucel (rap-cel) in autoimmune diseases following the deaths of three patients.

Manufacturing causes and safety profile of alternative CAR T therapies

• ▪Bristol Myers Squibb voluntarily froze autoimmune trials for its CAR T therapy zolacabtagene autoleucel (zola-cel) after observing transient and reversible inflammatory events.
• ▪IN8bio CEO Will Ho suggested safety setbacks with rap-cel and zola-cel stem from manufacturing process modifications designed to shorten T-cell expansion times before patient infusion.
• ▪Kyverna Therapeutics CEO Warner Biddle attributed miv-cel's favorable safety profile to its manufacturing process and a human CD28 co-stimulatory domain specifically designed for safety in autoimmune disease.

Kyverna Therapeutics advances stiff person syndrome treatment

• ▪Kyverna Therapeutics plans to complete a rolling biologics license application for mivocabtagene autoleucel (miv-cel) to treat stiff person syndrome by the end of 2026.
• ▪One-year durability data from Kyverna Therapeutics' Phase 2 KYSA-8 trial showed mivocabtagene autoleucel improved mobility in 26 stiff person syndrome patients without high-grade CRS, ICANS, or IEC-HS toxicities.

Debatable claims

• ▪CAR T-cell therapy is too dangerous to use for non-terminal autoimmune diseases
• ▪Expanding CAR T-cell therapy recommendations to pediatric autoimmune patients is premature
• ▪CAR T-cell therapies for autoimmune diseases should be administered strictly within clinical trials