Table 2 Adverse events, overall and by trial.
Events | Phase 1/2 (FT01) (n = 15) | Compassionate (FT02) (n = 6) | Phase 2 (FT03) (n = 15) | Overall (n = 36) |
|---|---|---|---|---|
CRS, n (%) | ||||
No CRS | 8 (53) | 4 (67) | 9 (69) | 21 (58) |
Grade 1 | 3 (20) | 1 (17) | 4 (27) | 8 (22) |
Grade 2 | 4 (27) | 1 (17) | 2 (13) | 7 (19) |
Grade ≥ 3 | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
ICANS, n (%) | ||||
No ICANs | 14 (93) | 6 (100) | 15 (100) | 35 (97) |
Grade 1 | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Grade 2 | 1 (7) | 0 (0) | 0 (0) | 1 (3) |
Grade ≥ 3 | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Neurotoxicity, n (%) | ||||
Grade 3 | 2 (13) | 0 (0) | 0 (0) | 2 (6) |
GVHD, n (%) | ||||
Grade 1–4 | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
Infection, n (%) | ||||
No infection | 11 (73) | 5 (83) | 10 (67) | 26 (72) |
Grade 1 | 1 (7) | 0 (0) | 1 (7) | 2 (6) |
Grade 2 | 1 (7) | 0 (0) | 1 (7) | 2 (6) |
Grade 3 | 0 (0) | 1 (17) | 3 (20) | 4 (11) |
Grade 4 | 1 (7) | 0 (0) | 0 (0) | 1 (3) |
Grade 5 | 1 (7) | 0 (0) | 0 (0) | 1 (3) |
Prolonged cytopenia, n (%)a | ||||
Grade ≥ 3 neutropenia, day 28 | 5 (45) | 3 (50) | 6 (43) | 14 (47) |
Grade ≥ 3 thrombocytopenia, day 28 | 4 (36) | 4 (80) | 7 (50) | 15 (50) |
Grade ≥ 3 neutropenia, day 90 | 0 (0) | 1 (25) | 6 (55) | 7 (33) |
Grade ≥ 3 thrombocytopenia, day 90 | 3 (50) | 1 (25) | 4 (36) | 8 (38) |
