Table 3.

DLT

Dose levelDose and scheduleNumber treatedDLT
1A5 µg/kg × 61None
2A10 µg/kg × 61None
3A20 µg/kg × 61None
3B20 µg/kg × 64None
4A30 µg/kg × 64Grade 3 and 4 CLS (1 case each*)
4B30 µg/kg × 65None
5B40 µg/kg × 68Grade 5 hypercalcemia (1 case)
5C32 [40] µg/kg × 1011Grade 4 hepatobiliary disorder (1 case)
6B50 µg/kg × 66None
6C50 µg/kg × 1014Grade 4 HUS (2 cases)
  • Cohorts: A: every other day × 6, no steroids; B: every other day × 6, dexamethasone prophylaxis cycle 1; C: every other day × 10, dexamethasone prophylaxis in cycle 1, doses 1 to 6.

  • * DLT preferred terms: vascular leak syndrome in 1 patient and bilateral pleural effusions, hypoxia, and hypertension in the other patient.

  • Manufacturing process change: 32 µg/kg equivalent to 40 µg/kg of prior product.