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 |
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 |