Table 2.
Summary of adverse events incidence, grade and duration by dose level
| Adverse Event | ||||
|---|---|---|---|---|
| DL-1 (n = 6) | DL-2 (n = 3) | DL-3 (n = 3) | Total (n = 12) | |
| Cytokine Release Syndrome (CRS) | ||||
| Any grade | 0 | 1 | 3 | 4 (33.3) |
| Grade 1/2 | 0 | 1 | 2 | 3 (25.0) |
| Grade ≥ 3 | 0 | 0 | 1 | 1 (8.3) |
| Time to onset, days (range) | - | 11 | 2 | 6.5 (2–11) |
| Time from onset to resolution, days (range) | - | 1 | 1 | 1 (1–1) |
| Immune Cell Associated Neurotoxicity Syndrome (ICANS) | ||||
| Any grade | 1 | 1 | 1 | 3 (25.0) |
| Grade 1/2 | 0 | 1 | 1 | 2 (16.7) |
| Grade ≥ 3 | 1 | 0 | 0 | 1 (8.3) |
| Time to onset, days (range) | 12 | 12 | 8 | 12 (8–12) |
| Time from onset to resolution, days (range) | 6 | 2 | 3 | 3 (2–6) |
| Other Adverse Events AE): | ||||
| Total Patients with Grade ≥ 3 AE | 4 | 1 | 2 | 7 (58.3) |
| Neutropenia | 4 | 1 | 2 | 7 (58.3) |
| Anemia | 3 | 0 | 1 | 4 (33.3) |
| Thrombocytopenia | 1 | 0 | 1 | 2 (16.7) |
| Infection | 1 | 0 | 1 | 2 (16.7) |
| vAnorexia | 0 | 0 | 1 | 1 (8.3) |
| Diarrhea | 0 | 0 | 1 | 1 (8.3) |
| COVID-19 | 0 | 1 | 0 | 1 (8.3) |
| Hypokalemia | 0 | 0 | 1 | 1 (8.3) |
| Pneumonia | 1 | 0 | 0 | 1 (8.3) |
| Sepsis | 0 | 0 | 1 | 1 (8.3) |