Clinical Pharmacology of Cytokine Release Syndrome with T-Cell-Engaging Bispecific Antibodies: Current Insights and Drug Development Strategies.

ABSTRACT: Cytokine release syndrome (CRS) is a common acute toxicity in T-cell therapies, including T-cell-engaging bispecific antibodies (T-BiSp). Effective CRS management and prevention are crucial in T-BiSp development. Required hospitalization for seven of the nine approved T-BiSp and the need for clinical intervention in severe cases highlight the importance of mitigation strategies to reduce health care burden and improve patient outcomes. In this review, we discuss the emerging evidence on CRS mitigation, management, and prediction. We cover different strategies for dose optimization, current and emerging (pre) treatment strategies, quantitative pharmacology tools used during drug development, and biomarkers and predictive factors. Insights are gleaned on step-up dosing and formulation effect

SUBMITTER: Radtke KK 

PROVIDER: S-EPMC11739781 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature