Table 3.
Treatment-emergent adverse events of special interest
| All patients (n = 23) |
Dose level 1 (n = 9) |
Dose level 2 (n = 14) |
|
|---|---|---|---|
| Patients with CRS | |||
| Any grade | 17 (74) | 7 (78) | 10 (71) |
| Grade 1 | 7 (30) | 3 (33) | 4 (29) |
| Grade 2 | 8 (35) | 4 (44) | 4 (29) |
| Grade 3 | 2 (9) | 0 | 2 (14) |
| Grade 4 | 0 | 0 | 0 |
| Grade 5 | 0 | 0 | 0 |
| Time to CRS onset, days | 3 (1-10) | 7 (1-10) | 2 (1-10) |
| Time to CRS resolution, days | 12 (2-50) | 6 (2-30) | 12.5 (2-50) |
| Patients with NEs* | |||
| Any grade | 9 (39) | 2 (22) | 7 (50) |
| Grade 1 | 0 | 0 | 0 |
| Grade 2 | 4 (17) | 0 | 4 (29) |
| Grade 3† | 4 (17) | 2 (22) | 2 (14) |
| Grade 4† | 1 (4) | 0 | 1 (7) |
| Grade 5 | 0 | 0 | 0 |
| Time to NE onset, days | 4 (2-21) | 16 (11-21) | 4 (2-11) |
| Time to NE resolution, days | 20.5 (6-50) | 8.5 (6-11) | 29.5 (9-50) |
| Patients with CRS and/or NE | 18 (78) | 7 (78) | 11 (79) |
| Patients with CRS only | 9 (39) | 5 (56) | 4 (29) |
| Patients with NE only | 1 (4) | 0 | 1 (7) |
| Tocilizumab and/or corticosteroid use | |||
| Tocilizumab only | 6 (26) | 3 (33) | 3 (21) |
| Corticosteroids only | 1 (4) | 0 | 1 (7) |
| Both tocilizumab and corticosteroids | 8 (35) | 2 (22) | 6 (43) |
| Tocilizumab and/or corticosteroids | 15 (65) | 5 (56) | 10 (71) |
Data are expressed as n (%) or median (range).
*
NEs were liso-cel–related neurological adverse events defined by the investigator.
†
NEs were not mutually exclusive (encephalopathy [n = 3], aphasia [n = 1], confusional state [n = 1], muscular weakness [n = 1], somnolence [n = 1]).