Digital Patient & Digital Twin: CAR-T Cytokine Release Syndrome (CRS)


To monitor the safety of a new CAR-T treatment, specifically the incidence and grade of CRS – a serious side effect of treatment – in a hematologic malignancies trial. 


Real-world data, coupled with deep and innovative analysis using Phesi’s Trial Accelerator™ platform, was used to improve decision making and ensure patient safety throughout the trial.

  • Phesi created a digital patient profile to establish baseline characteristics.
  • 5,335 patients from 63 cohorts matched the characteristics and treatment profile.
  • 650 patients were identified as having complete grade detail related to CRS toxicity.
  • Phesi used patient-centric data to construct a digital twin to monitor CRS toxicity. 
  • Phesi analysis determined CRS toxicity of the CAR-T treatment did not increase the safety risk for patients and instead was trending towards lower NCI toxicity grades.



Phesi’s approach supported internal decision making and was used to guide discussions on reducing patient and investigator site burden, cost and trial duration.


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