Table 3.
Treatment-emergent AEs suspected to be related to Inati-cel, occurring in at least 20% of patients, and AEs of special interest
| Inati-cel adverse reactions | n = 48 |
||
|---|---|---|---|
| All grades, n (%) | Grade 3/4, n (%) | Grade 5, n (%) | |
| AEs of special interest | |||
| CRS | 42 (87.5%) | 6 (12.5%) | 0 |
| ICANS | 4 (8.3%) | 3 (6.2%) | 0 |
| Hypogammaglobulinemia | 30 (62.5%) | 0 | 0 |
| Infection | 33 (68.8%) | 21 (43.8%) | 2 (4.2%) |
| HLH/MAS | 3 (6.2%) | 1 (2.1%) | 0 |
| Hematologic | |||
| Neutropenia | 46 (95.8%) | 46 (95.8%) | 0 |
| Leukopenia | 46 (95.8%) | 46 (95.8%) | 0 |
| Anemia | 44 (91.7%) | 38 (79.2%) | 0 |
| Thrombocytopenia | 43 (89.6%) | 37 (77.1%) | 1 (2.1%) |
| Lymphopenia | 42 (87.5%) | 42 (87.5%) | 0 |
| Hyperfibrinolysis | 15 (31.2%) | 1 (2.1%) | |
| Coagulopathy | 10 (20.8%) | 3 (6.2%) | 0 |
| Investigations | |||
| Alanine aminotransferase increased | 22 (45.8%) | 0 | 0 |
| Globulins decreased | 20 (41.7%) | 0 | 0 |
| Blood fibrinogen decreased | 19 (39.6%) | 10 (20.8%) | 0 |
| Aspartate aminotransferase increased | 16 (33.3%) | 2 (4.2%) | 0 |
| γ-glutamyltransferase increased | 15 (31.2%) | 4 (8.3%) | 0 |
| Blood bilirubin increased | 10 (20.8%) | 2 (4.2%) | 0 |
| Metabolism and nutritional disorders | |||
| Hypokalemia | 24 (50.0%) | 4 (8.3%) | 0 |
| Hypocalcemia | 13 (27.1%) | 1 (2.1%) | 0 |
| Hypertriglyceridemia | 12 (25.0%) | 1 (2.1%) | 0 |
| Hypoalbuminemia | 11 (22.9%) | 1 (2.1%) | 0 |