Table 2.
Overall safety profile by dose level of YTB323
| DL1 (2.5 × 106) n = 4 | DL2 (12.5 × 106) n = 16 | |||
|---|---|---|---|---|
| Any grade n (%) | Grade ≥3 n (%) | Any grade n (%) | Grade ≥3 n (%) | |
| Adverse events | ||||
| Any AEa | 4 (100) | 4 (100) | 16 (100) | 12 (75) |
| Deathb | 2 (50) | 2 (50) | 3 (19) | 3 (19) |
| Related to YTB323 | 0 | 0 | ||
| Infections | 2 (50) | 1 (25) | 3 (19) | 1 (6) |
| CRSc | 1 (25) | 0 | 5 (31) | 1 (6) |
| Neurologic AR | 1 (25) | 0 | 4 (25)d | 1 (6) |
| Hematology laboratory abnormalities after YTB323 treatment | ||||
| Any cytopeniae | 4 (100) | 4 (100) | 16 (100) | 16 (100) |
| Anemia | 4 (100) | 4 (100) | 16 (100) | 7 (44) |
| Leukopenia | 4 (100) | 3 (75) | 16 (100) | 14 (88) |
| Lymphopenia | 4 (100) | 3 (75) | 16 (100) | 16 (100) |
| Neutropenia | 4 (100) | 4 (100) | 16 (100) | 14 (88) |
| Thrombocytopenia | 4 (100) | 2 (50) | 16 (100) | 8 (50) |
NOTE: MedDRA v24.0 and CTCAE v5.0 were used for the reporting of AEs.
Abbreviations: AE, adverse event; AR, adverse reaction; CRS, cytokine release syndrome; CTCAE, Common Terminology Criteria for Adverse Events; DL, dose level; ICANS, immune effector cell–associated neurotoxicity syndrome; MedDRA, Medical Dictionary for Regulatory Activities.
aAll AEs were reported regardless of the study drug relationship.
bThree deaths were due to disease progression (1 at DL1, 2 at DL2), 1 was due to intestinal hemorrhage (at DL2), and 1 was due to sepsis (at DL1).
cGrading of CRS according to Lee et al. (16) criteria.
dOne patient experienced a grade 2 seizure that constituted grade 3 ICANS, and 1 other patient experienced grade 3 ICANS.
eReported regardless of study drug relationship.