AEs by dose level
| AEs . | 2 × 106 cells per kg n = 4 . | 3.25 × 106 cells per kg n = 4 . | 5 × 106 cells per kg n = 5 . | |||
|---|---|---|---|---|---|---|
| All grades n (%) . | Grade ≥3 n (%) . | All grades n (%) . | Grade ≥3 n (%) . | All grades n (%) . | Grade ≥3 n (%) . | |
| Lymphocyte count decreased | 4 (100) | 2 (50) | 4 (100) | 1 (25) | 5 (100) | 3 (60) |
| Neutrophil count decreased | 4 (100) | 3 (75) | 4 (100) | 4 (100) | 5 (100) | 5 (100) |
| White blood cells decreased | 4 (100) | 4 (100) | 4 (100) | 4 (100) | 5 (100) | 4 (80) |
| Anemia | 4 (100) | 1 (25) | 4 (100) | 0 | 4 (80) | 2 (40) |
| Platelet count decreased | 3 (75) | 1 (25) | 4 (100) | 1 (25) | 4 (80) | 1 (25) |
| Bacteremia | 1 (25) | 1 (25) | 0 | 0 | 0 | 0 |
| Sepsis | 2 (50) | 2 (50) | 0 | 0 | 0 | 0 |
| Shingles | 0 | 0 | 0 | 0 | 1 (20) | 1 (20) |
| Grade | 1–2 n (%) | 1–2 n (%) | 1–2 n (%) | |||
| CRS | 4 (100) | 2 (50) | 3 (60) | |||
| Fatigue | 3 (75) | 2 (50) | 4 (80) | |||
| Hypertension | 2 (50) | 1 (25) | 2 (40) | |||
| Sinus tachycardia | 2 (50) | 1 (25) | 2 (40) | |||
| Upper respiratory infection | 0 | 1 (25) | 1 (20) | |||
| Aspartate aminotransferase increased | 1 (25) | 1 (25) | 0 | |||
| Alanine aminotransferase increased | 1 (25) | 1 (25) | 0 | |||
| Activated partial thromboplastin time prolonged | 1 (25) | 1 (25) | 2 (40) | |||
| AEs . | 2 × 106 cells per kg n = 4 . | 3.25 × 106 cells per kg n = 4 . | 5 × 106 cells per kg n = 5 . | |||
|---|---|---|---|---|---|---|
| All grades n (%) . | Grade ≥3 n (%) . | All grades n (%) . | Grade ≥3 n (%) . | All grades n (%) . | Grade ≥3 n (%) . | |
| Lymphocyte count decreased | 4 (100) | 2 (50) | 4 (100) | 1 (25) | 5 (100) | 3 (60) |
| Neutrophil count decreased | 4 (100) | 3 (75) | 4 (100) | 4 (100) | 5 (100) | 5 (100) |
| White blood cells decreased | 4 (100) | 4 (100) | 4 (100) | 4 (100) | 5 (100) | 4 (80) |
| Anemia | 4 (100) | 1 (25) | 4 (100) | 0 | 4 (80) | 2 (40) |
| Platelet count decreased | 3 (75) | 1 (25) | 4 (100) | 1 (25) | 4 (80) | 1 (25) |
| Bacteremia | 1 (25) | 1 (25) | 0 | 0 | 0 | 0 |
| Sepsis | 2 (50) | 2 (50) | 0 | 0 | 0 | 0 |
| Shingles | 0 | 0 | 0 | 0 | 1 (20) | 1 (20) |
| Grade | 1–2 n (%) | 1–2 n (%) | 1–2 n (%) | |||
| CRS | 4 (100) | 2 (50) | 3 (60) | |||
| Fatigue | 3 (75) | 2 (50) | 4 (80) | |||
| Hypertension | 2 (50) | 1 (25) | 2 (40) | |||
| Sinus tachycardia | 2 (50) | 1 (25) | 2 (40) | |||
| Upper respiratory infection | 0 | 1 (25) | 1 (20) | |||
| Aspartate aminotransferase increased | 1 (25) | 1 (25) | 0 | |||
| Alanine aminotransferase increased | 1 (25) | 1 (25) | 0 | |||
| Activated partial thromboplastin time prolonged | 1 (25) | 1 (25) | 2 (40) | |||
Listed are the grade 1 to 2 AEs that occurred in at least 15% of the patients and all events of grade 3 or higher occurred in patients from the time of infusion of CAR T cells until day 90. All were graded per the CTCAE version 5.0 except CRS, which was graded according to the criteria of Lee et al10.