Case Study

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

Source: Medidata AI
Scientist Lab Research GettyImages-1309776504

​​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.
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