Table 2.
Report of CRS, ICANS, GvHD, and infections in safety analysis set by dose level.
| CAR T-cell dose | DL1 (3 × 107) | DL2 (1 × 108) | DL3 (3 × 108) | DL4 (9 × 108) | Total | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| N = 3 | N = 3 | N = 6 | N = 4 | N = 16 | ||||||
| Gr 1/2 | Gr ≥3 | Gr 1/2 | Gr ≥3 | Gr 1/2 | Gr ≥3 | Gr 1/2 | Gr ≥3 | Gr 1/2 | Gr ≥3 | |
| CRS, n (%) | – | – | – | – | 4 (66.7) | – | 4 (100.0) | – | 8 (50.0) | – |
| ICANS, n (%) | – | – | – | – | – | – | – | – | – | – |
| GvHD, n (%) | – | – | – | – | – | – | – | – | – | – |
| Infectionsa, n (%) | – | – | – | 1 (33.3) | 1 (16.7) | 2 (33.3) | 2 (50.0) | – | 3 (18.8) | 3 (18.8) |
a
Includes COVID-19, pneumonia, enterocolitis, urinary tract infections, upper respiratory tract infections, sinusitis, mucosal infection, folliculitis, and device-related infection.
Abbreviations: CAR, chimeric antigen receptor; COVID-19, coronavirus disease 2019; CRS, cytokine release syndrome; DL, dose level; Gr, grade; GvHD, graft versus host disease; ICANS, immune effector cell–associated neurotoxicity syndrome.