DLT
| Dose level . | Dose and schedule . | Number treated . | DLT . |
|---|---|---|---|
| 1A | 5 µg/kg × 6 | 1 | None |
| 2A | 10 µg/kg × 6 | 1 | None |
| 3A | 20 µg/kg × 6 | 1 | None |
| 3B | 20 µg/kg × 6 | 4 | None |
| 4A | 30 µg/kg × 6 | 4 | Grade 3 and 4 CLS (1 case each*) |
| 4B | 30 µg/kg × 6 | 5 | None |
| 5B | 40 µg/kg × 6 | 8 | Grade 5 hypercalcemia (1 case) |
| 5C | 32† [40] µg/kg × 10 | 11 | Grade 4 hepatobiliary disorder (1 case) |
| 6B | 50 µg/kg × 6 | 6 | None |
| 6C | 50 µg/kg × 10 | 14 | Grade 4 HUS (2 cases) |
| Dose level . | Dose and schedule . | Number treated . | DLT . |
|---|---|---|---|
| 1A | 5 µg/kg × 6 | 1 | None |
| 2A | 10 µg/kg × 6 | 1 | None |
| 3A | 20 µg/kg × 6 | 1 | None |
| 3B | 20 µg/kg × 6 | 4 | None |
| 4A | 30 µg/kg × 6 | 4 | Grade 3 and 4 CLS (1 case each*) |
| 4B | 30 µg/kg × 6 | 5 | None |
| 5B | 40 µg/kg × 6 | 8 | Grade 5 hypercalcemia (1 case) |
| 5C | 32† [40] µg/kg × 10 | 11 | Grade 4 hepatobiliary disorder (1 case) |
| 6B | 50 µg/kg × 6 | 6 | None |
| 6C | 50 µg/kg × 10 | 14 | Grade 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.