AEs of CTCAE grade 3 or higher (safety population)
| System organ class and preferred term . | Cohort 1: 0.01 mg/kg (n = 3) . | Cohort 2: 0.04 mg/kg (n = 3) . | Cohort 3: 0.15 mg/kg (n = 3) . | Cohort 4: 0.5 mg/kg (n = 6) . | Cohort 5: 1.5 mg/kg (n = 3) . | Cohort 6: 4.5 mg/kg (n = 3) . | Cohort 7: 7 mg/kg (n = 3) . | Cohort 8: 2 × 4.5 mg/kg (n = 4) . | Overall (n = 28) . |
|---|---|---|---|---|---|---|---|---|---|
| Any AE of CTCAE grade ≥3 | 0 | 0 | 0 | 1 (16.7) | 3 (100.0) | 1 (33.3) | 2 (66.7) | 1 (25.0) | 8 (28.6) |
| Blood and lymphatic disorders | |||||||||
| Anemia | 0 | 0 | 0 | 1 (16.7) | 0 | 1 (33.3) | 0 | 0 | 2 (7.1) |
| Hemolytic anemia | 0 | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | 0 | 1 (3.6) |
| Thrombocytopenia | 0 | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | 0 | 1 (3.6) |
| General disorders | |||||||||
| Multiorgan failure | 0 | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | 0 | 1 (3.6) |
| Pyrexia | 0 | 0 | 0 | 0 | 1 (33.3) | 0 | 0 | 0 | 1 (3.6) |
| Thrombosis in device | 0 | 0 | 0 | 0 | 1 (33.3) | 0 | 0 | 0 | 1 (3.6) |
| Infections and infestations | |||||||||
| Bronchitis | 0 | 0 | 0 | 0 | 1 (33.3) | 0 | 0 | 0 | 1 (3.6) |
| Pneumonia | 0 | 0 | 0 | 1 (16.7) | 1 (33.3) | 0 | 1 (33.3) | 1 (25.0) | 4 (14.3) |
| Staphylococcal infection | 0 | 0 | 0 | 0 | 0 | 0 | 1 (33.3) | 0 | 1 (3.6) |
| Investigations | |||||||||
| Bilirubin increased | 0 | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | 0 | 1 (3.6) |
| Metabolism and nutrition | |||||||||
| Hypoalbuminemia | 0 | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | 0 | 1 (3.6) |
| Neoplasms | |||||||||
| T-cell lymphoma | 0 | 0 | 0 | 0 | 1 (33.3) | 0 | 0 | 0 | 1 (3.6) |
| System organ class and preferred term . | Cohort 1: 0.01 mg/kg (n = 3) . | Cohort 2: 0.04 mg/kg (n = 3) . | Cohort 3: 0.15 mg/kg (n = 3) . | Cohort 4: 0.5 mg/kg (n = 6) . | Cohort 5: 1.5 mg/kg (n = 3) . | Cohort 6: 4.5 mg/kg (n = 3) . | Cohort 7: 7 mg/kg (n = 3) . | Cohort 8: 2 × 4.5 mg/kg (n = 4) . | Overall (n = 28) . |
|---|---|---|---|---|---|---|---|---|---|
| Any AE of CTCAE grade ≥3 | 0 | 0 | 0 | 1 (16.7) | 3 (100.0) | 1 (33.3) | 2 (66.7) | 1 (25.0) | 8 (28.6) |
| Blood and lymphatic disorders | |||||||||
| Anemia | 0 | 0 | 0 | 1 (16.7) | 0 | 1 (33.3) | 0 | 0 | 2 (7.1) |
| Hemolytic anemia | 0 | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | 0 | 1 (3.6) |
| Thrombocytopenia | 0 | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | 0 | 1 (3.6) |
| General disorders | |||||||||
| Multiorgan failure | 0 | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | 0 | 1 (3.6) |
| Pyrexia | 0 | 0 | 0 | 0 | 1 (33.3) | 0 | 0 | 0 | 1 (3.6) |
| Thrombosis in device | 0 | 0 | 0 | 0 | 1 (33.3) | 0 | 0 | 0 | 1 (3.6) |
| Infections and infestations | |||||||||
| Bronchitis | 0 | 0 | 0 | 0 | 1 (33.3) | 0 | 0 | 0 | 1 (3.6) |
| Pneumonia | 0 | 0 | 0 | 1 (16.7) | 1 (33.3) | 0 | 1 (33.3) | 1 (25.0) | 4 (14.3) |
| Staphylococcal infection | 0 | 0 | 0 | 0 | 0 | 0 | 1 (33.3) | 0 | 1 (3.6) |
| Investigations | |||||||||
| Bilirubin increased | 0 | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | 0 | 1 (3.6) |
| Metabolism and nutrition | |||||||||
| Hypoalbuminemia | 0 | 0 | 0 | 1 (16.7) | 0 | 0 | 0 | 0 | 1 (3.6) |
| Neoplasms | |||||||||
| T-cell lymphoma | 0 | 0 | 0 | 0 | 1 (33.3) | 0 | 0 | 0 | 1 (3.6) |
Data are presented as n (%) of AEs.