HSS Study Highlights Potential for CAR T-Cell Therapy to Transform Lupus Treatment

A type of cellular therapy originally developed to treat cancer is showing promise as a potential treatment for people with difficult-to-treat lupus, according to a new study from researchers at Hospital for Special Surgery (HSS). Known as chimeric antigen receptor (CAR) T-cell therapy, the approach is increasingly being investigated for the treatment of systemic lupus erythematosus (SLE). The study, CAR T-Cell Therapy in SLE: A Pooled Analysis, was presented today at the annual meeting of the American College of Rheumatology, ACR Convergence 2026.

Lupus is a chronic autoimmune disease in which the immune system mistakenly attacks healthy tissue, causing widespread inflammation that can damage the organs, joints and skin.¹ While advances in treatment have greatly improved care, lupus has no cure, and some patients do not respond adequately to available therapies.

Cellular therapy harnesses the power of the immune system to fight malignancies and, more recently, autoimmune diseases. In lupus, CAR T therapies under investigation include approaches that target B cells involved in the autoimmune response.

To better understand the potential of CAR T-cell therapy for these patients, HSS researchers conducted a systematic review of 31 studies involving 243 people with lupus who had previously tried at least two immunosuppressants and evaluated outcomes over a two-year period. The majority of participants were treated with personalized CD19-targeted CAR T therapies using their own immune cells. In the analysis, CAR T-cell therapy demonstrated consistent efficacy in those who initially had high disease activity, leading to near-complete resolution of symptoms by six months.

The analysis also found an encouraging safety profile. Cytokine release syndrome (CRS), a damaging inflammatory response that can occur as a side effect of advanced immunotherapies, was generally mild; immune effector cell-associated neurotoxicity syndrome (ICANS), a neurological complication of T-cell therapy, was infrequent. Together, these findings highlight the potential for CAR T-cell therapy to transform lupus treatment.

"CAR T-cell therapy is poised to revolutionize the management of lupus and other autoimmune diseases, shifting treatment goals from disease control toward sustained remission and, potentially, a cure," said Anca D. Askanase, MD, MPH, Chair of the Department of Medicine and Chief of the Division of Rheumatology at HSS and senior author of the study. "This study provides clinicians and people living with lupus, particularly those for whom conventional treatments have failed, with a broader perspective on the efficacy and safety of CAR T-cell therapy across clinical trials. These encouraging findings may help inform patient selection for future studies and, ultimately, clinical practice."

Key findings include:

· Mean systemic lupus erythematosus disease activity index (SLEDAI) scores, a measure of lupus disease activity, decreased from 13.0 at baseline to 2.2 at six months after treatment

· 64% of participants experienced CRS, 61% of the 243 had low grade CRS (grade 1 or 2)

· 5% of participants experienced ICANS

· 5% of participants experienced severe (grade 3 or 4) infections

· 6% of participants experienced hematologic toxicity lasting more than 28 days

As data on CAR T-cell therapy in SLE rapidly accumulates, individual studies remain limited by small sample size, making it challenging to assess the efficacy and safety of these new therapies. This comprehensive analysis brings together the available evidence to provide a broader understanding of CAR T-cell therapy in refractory SLE. The findings add to a growing body of research supporting the continued investigation into immunotherapy for lupus. Larger prospective studies will be important to better understand long-term outcomes, identify which patients stand to benefit the most, and determine how CAR T therapy could reshape lupus care.

References:

1. Lupus Foundation of America. Lupus Facts and Statistics. Last updated April 11, 2025. Accessed November 8, 2026. www.lupus.org/resources/lupus-facts-and-statistics.