Predictors Of Severe CRS In Longitudinal CAR T-Cell Clinical Trial Data

​​Background

• Cytokine release syndrome (CRS) is a life-threatening toxicity of chimeric antigen receptor (CAR) T-cell therapy and there is a limited understanding of its risk factors.1-2
• Since 2016, no fewer than 15 trials have been put on hold or abandoned due to safety concerns arising out of CRS.
• Known markers of severe CRS lack specificity or require specialized lab facilities, making them impractical for safety surveillance during trials.¹
• Prior studies on risk factors of CRS following CAR-T treatment are based on small numbers of subjects and findings have not been validated externally.
• Even less is known about the temporal patterns in hematological and chemistry markers collected during CAR-T treatments and their potential use in safety surveillance.