Table 2.
Treatment-emergent AEs of special interest (grade 3 and higher)
| AEs | DL0 (%) | DL1 (%) | DL2 (%) | DL3 (%) | DL3.5 (%) | DL4 (%) | DL5 (%) | Overall (%) |
|---|---|---|---|---|---|---|---|---|
| Gavo-cel dose (cells per m2) | 5 × 107/m2* | 5 × 107/m2 | 1 × 108/m2* | 1 × 108/m2 | 3 × 108/m2 | 5 × 108/m2* | 5 × 108/m2 | |
| Number of patients | 1 | 8 | 1 | 13 | 5 | 1 | 3 | 32 |
| Hematologic toxicity | ||||||||
| Lymphopenia | 1 (100) | 8 (100) | 0 | 13 (100) | 5 (100) | 1 (100) | 3 (100) | 31 (97) |
| Neutropenia | 0 | 8 (100) | 0 | 13 (100) | 5 (100) | 0 | 3 (100) | 29 (91) |
| Thrombocytopenia | 0 | 2 (25) | 0 | 2 (15) | 1 (20) | 0 | 2 (67) | 7 (22) |
| On-target/on-tumor | ||||||||
| CRS | 0 | 2 (25) | 0 | 2 (15) | 1 (20) | 0 | 3 (100) | 8 (25) |
| On-target/off-tumor | ||||||||
| Pericarditis/pericardial effusion | 0 | 0 | 0 | 0 | 1 (20) | 0 | 0 | 1 (3) |
| Pleuritis/pleural effusion | 0 | 0 | 0 | 1 (8) | 1 (20) | 0 | 0 | 2 (6) |
| Peritonitis/ascites | 0 | 0 | 0 | 1 (8) | 0 | 0 | 0 | 1 (3) |
| Other | ||||||||
| Pneumonitis | 0 | 1 (13) | 0 | 0 | 3§+ (60) | 0 | 1 (33) | 5 (16) |
| Sepsis | 0 | 1 (13)§++ | 0 | 0 | 0 | 0 | 0 | 1 (3) |
| Hemorrhage | 0 | 0 | 0 | 0 | 0 | 0 | 1 (33)§+++ | 1 (3) |
| Respiratory failure | 0 | 0 | 0 | 0 | 0 | 0 | 1 (33)§++++ |
All emergent AEs described in the table were deemed at least possibly related to protocol-defined therapy.
* No LD.
§ Grade 5 AEs: +One patient developed respiratory failure possibly related to gavo-cel; ++patient developed fungal sepsis unrelated to gavo-cel; +++patient had bronchioalveolar hemorrhage after CRS-related disseminated intravascular coagulation; ++++respiratory failure in patient with concomitant CMV pulmonary infection and pneumothorax.