CAR T-cell–associated adverse events
| Event . | Any, n (%) . | Severe (grade 3/4) n (%) . |
|---|---|---|
| CRS | 20 (80) | 4 (16) |
| Tachycardia | 15 (60) | 0 |
| Hypertension | 5 (20) | 1 (4) |
| Cardiac dysfunction/arrhythmia | 1 (4) | 1 (4) |
| Cytopenia | ||
| Neutropenia | 3 (12) | 3 (12) |
| Thrombocytopenia | 4 (16) | 4 (16) |
| Infection | 9 (36) | 6 (24) |
| CAR T-cell–associated neurotoxicity | 18 (72) | 7 (28) |
| Headache | 5 (20) | 1 (8) |
| Tremor or hyperreflexia/clonus | 7 (28) | 0 |
| Altered mental status* | 12 (48) | 5 (20) |
| Seizure (clinical or abnormal EEG)† | 5 (20) | 5 (20) |
| Involuntary movements | 1 (8) | 0 |
| Ataxia | 1 (8) | 0 |
| Event . | Any, n (%) . | Severe (grade 3/4) n (%) . |
|---|---|---|
| CRS | 20 (80) | 4 (16) |
| Tachycardia | 15 (60) | 0 |
| Hypertension | 5 (20) | 1 (4) |
| Cardiac dysfunction/arrhythmia | 1 (4) | 1 (4) |
| Cytopenia | ||
| Neutropenia | 3 (12) | 3 (12) |
| Thrombocytopenia | 4 (16) | 4 (16) |
| Infection | 9 (36) | 6 (24) |
| CAR T-cell–associated neurotoxicity | 18 (72) | 7 (28) |
| Headache | 5 (20) | 1 (8) |
| Tremor or hyperreflexia/clonus | 7 (28) | 0 |
| Altered mental status* | 12 (48) | 5 (20) |
| Seizure (clinical or abnormal EEG)† | 5 (20) | 5 (20) |
| Involuntary movements | 1 (8) | 0 |
| Ataxia | 1 (8) | 0 |
Adverse events were captured for all treated patients (n = 25) until disease relapse, application of alternative therapy, or death. CRS was graded according to the NCI consensus CRS grading system. CRS symptoms include fever, which occurred in 68% (17/25), hypotension in 44% (11/25), and hypoxia in 12% (3/25) of patients. ASTCT CRS consensus grading (fever a required element) occurred in 68% (17/25) of patients, including a sCRS rate of 16% (4/25) of patients. CAR T-cell–associated neurotoxicity included any neurologic sequalae following the infusion of CAR T cells. EEG, electroencephalogram.
Altered mental status included somnolence, depressed level of consciousness, confusion, slurred speech, cognitive disturbance, delirium, and/or personality change.
Seizure included clinically apparent seizure or electroencephalogram findings consistent with seizure.