Table 1.

Tisagenlecleucel cellular kinetic parameters in responding patients and nonresponding patients

ParameterStatisticCR/CRi (N = 62)NR (N = 8)
AUC0-28d, copies/μg of DNA × daysn616
Geometric mean (CV%)318,000 (177.8)156,000 (99.4)
Percent change (CR/CRi vs. NR)104%
Median (range)420,000 (21,000–2,740,000)129,000 (72,300–711,000)
Cmax, copies/μgan617
Geometric mean (CV%)34,700 (155.4)20,000 (71.6)
Percent change (CR/CRi vs. NR)74%
Median (range)44,800 (2,210–316,000)22,000 (9,700–57,700)
Tmax, daysn617
Median (min–max)9.91 (0.00764–27.0)20.0 (0.0278–62.7)
T1/2, daysn543
Geometric mean (CV%)16.8 (155.9)2.52 (171.9)
Tlast, daysn628
Median (min–max)102 (17.8–380)27.8 (20.9–83.9)
  • Abbreviations: AUC, area under the curve; Cmax, maximum (peak) expansion; CR, complete remission; CRi, complete remission with incomplete blood count recovery; CV%, coefficient of variation; max, maximum; min, minimum; NR, nonresponding response; T1/2, half-life; Tlast, time of last measurable in peripheral blood; Tmax, time to reach maximum (peak) peripheral blood tisagenlecleucel transgene level.

  • aSeven patients had a Cmax determined from samples collected <1 day after infusion; these samples may represent the amount of tisagenlecleucel in the catheter rather than the amount of expanded tisagenlecleucel.