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Biomarkers identified for cytokine release syndrome risk after CAR T-cell therapy

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Biomarkers identified for cytokine release syndrome risk after CAR T-cell therapy

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For patients with autoimmune disease, higher baseline B-cell counts and systemic inflammation are associated with development of cytokine release syndrome (CRS) after chimeric antigen receptor (CAR) T-cell therapy, according to a study published in the November issue of The Lancet Rheumatology.

Shirley Chiu Wai Chan, M.B.B.S., from Universitätsklinikum Erlangen in Germany, and colleagues conducted a retrospective cohort study in patients with autoimmune diseases treated with autologous CAR T-cell therapy from six centers in Germany and one in China to identify biomarkers predicting incidence and severity of CRS.

A total of 108 patients with autoimmune diseases who received autologous CAR T-cell therapy between March 1, 2021, and July 1, 2025, were included. The researchers found that 80% of patients developed CRS after CAR T-cell therapy (grades 1, 2, and 3 in 66%, 13%, and 1%, respectively). Three patients (3%) developed immune effector cell–associated neurotoxicity syndrome (grades 1 and 2 in 2% and 1%, respectively).

Compared with patients without CRS, those who developed CRS had significantly higher baseline B-cell counts, interleukin (IL)-6 concentrations, and C-reactive protein concentrations. The association between CRS and B-cell counts and IL-6 concentrations was confirmed in multivariable logistic regression (odds ratios, 1.31 and 2.28, respectively).

"These data ... support the biomarker-based identification of populations at increased risk for CRS that might be tackled with preventive treatment or more intense monitoring before and after CAR T-cell administration," the authors write.


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