Table II.
Non-Dose Limiting Hematologic Toxicities Observed in Evaluable Patients
| Part A NTX-010 dose level 1 (1×109 vp/kg; n=6) | ||||||||
| Toxicity Type |
Maximum grade of toxicity across cycle
1 (Total, 6 cycles) |
Maximum grade of toxicity across post
documented viral clearance cycles (Total, 4 cycles) |
||||||
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
| Anemia | 1 | 2 | ||||||
| Lymphocyte count decreased | 2 | |||||||
| Neutrophil count decreased | 2 | 1 | 1 | 1 | ||||
| Platelet count decreased | 2 | 1 | ||||||
| White blood cell decreased | 3 | 1 | ||||||
| Part A NTX-010 dose level 2 (1×1010 vp/kg; n=3) | ||||||||
| Toxicity Type |
Maximum grade of toxicity across
cycle 1 (Total, 3 cycles) |
Maximum grade of toxicity across post
documented viral clearance cycles (Total, 5 cycles) |
||||||
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
| Anemia | 1 | 1 | ||||||
| Lymphocyte count decreased | 1 | 1 | 2 | |||||
| Neutrophil count decreased | 1 | 1 | ||||||
| Platelet count decreased | 3 | 1 | ||||||
| White blood cell decreased | 1 | 2 | ||||||
| Part A NTX-010 dose level 3 (1×1011vp/kg; n=3) | ||||||||
| Toxicity Type |
Maximum grade of toxicity across
cycle 1 (Total, 3 cycles) |
Maximum grade of toxicity across post
documented viral clearance cycles (Total, 3 cycles) |
||||||
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
| Anemia | 1 | 1 | ||||||
| Lymphocyte count decreased | 2 | 1 | ||||||
| Neutrophil count decreased | 1 | 1 | ||||||
| Platelet count decreased | 1 | 1 | ||||||
| White blood cell decreased | 2 | 1 | ||||||
| Part B NTX-010 dose level 1 (1×1011vp/kg plus cyclophosphamide; n=6) | ||||||||
| Toxicity Type |
Maximum grade of toxicity across
cycle 1 (Total, 6 cycles) |
Maximum grade of toxicity across post
documented viral clearance cycles (Total, 4 cycles) |
||||||
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
| Anemia | 2 | 2 | ||||||
| Lymphocyte count decreased | 2 | 2 | 2 | |||||
| Neutrophil count decreased | 1 | 4 | ||||||
| Platelet count decreased | 1 | 2 | 1 | |||||
| White blood cell decreased | 2 | 3 | ||||||