Rapid longitudinal cytokine profile monitoring of patients with hematologic cancer undergoing CAR T-cell therapy. (A) Representative timeline of cytokine profile monitoring. Daily blood draw in general started 5 days before the infusion for baseline collection until the patient was discharged. In the near-real-time monitoring test, the sample was first processed within 45 minutes of blood draw to extract serum and then tested by using the PEdELISA assay within 1 hour. The data typically became available for clinicians within 2 to 3 hours from the initial point of patient blood collection. (B) Good agreement (R² = 0.915) between the PEdELISA and LEGENDplex assays found in measurements of 20 CAR T-patient samples at time points randomly chosen for 6 cytokines. (C) Clinical summary of 10 CAR-T patients that includes the maximum CRS score/CRES grade and the number of measurement time points. (D) Distribution of CRS and non-CRS periods (days) during the entire inpatient duration for 10 CAR-T patients. (E) Baseline cytokine levels of CAR-T patients before CAR T-cell infusion. (F-O) Heatmaps showing the clinical severity quantified according to CRS and CRES grading, the standard scores (z scores) of CRP and ferritin levels, and the standard scores (z scores) of serum cytokine profiles obtained by PEdELISA for 10 CAR-T patients. The grading of CRS, CRES, hypotension, and hypoxia was based on the American Society for Transplantation and Cellular Therapy Consensus Grading.³⁶  Here, each standard score (z score) was calculated based on triplicate measurements of each analyte concentration value. Day 0 represents the day of CAR T-cell infusion; data before day 0 represent the baseline. The patients were grouped according to the severity of CRS or neurotoxicity. (F) Data of patient 06 (grade 4 severe CRS). (G-I) Data of patients 02, 08, and 34 (grade 2 mid-CRS). (J) Data of patient 05 (grade 3 neurotoxicity). (K-O) Data of patients 12, 14, 17, 25, and 33 (grade 0-1 mild or no CRS). Time plots of concentration are additionally shown for IL-6 and TNF-α to provide information on the outcomes of the treatments with tocilizumab (anti–IL-6R) and infliximab (anti–TNF-α). The green/yellow dotted vertical lines represent the time points of tocilizumab/infliximab dosing. The shadow region in panels F and J represents the period in which the patients received dexamethasone.