Summary of immunotoxicity based on AUTO3 dose received
| . | 50 × 106 AUTO3 No Pembro. (N = 4) . | 50 × 106 AUTO3 D14 Pembro. (N = 3) . | 150 × 106-450 × 106 AUTO3 D14 Pembro. (N = 8) . | 150 × 106-450 × 106 AUTO3 D1 Pembro. inpatient (N = 17) . | 150 × 106-450 × 106 AUTO3 D1 Pembro. OPD (N = 20) . | Total (N = 52) . |
|---|---|---|---|---|---|---|
| Maximum grade CRS (ASTCT criteria) | ||||||
| G1 | 1 (25%) | 0 | 2 (25%) | 4 (23.5%) | 4 (20%) | 11 (21.2%) |
| G2 | 0 | 0 | 2 (25%) | 1 (5.9%) | 4 (20%) | 7 (13.5%) |
| G3 | 0 | 0 | 0 | 0 | 1 (5%)∗ | 1 (1.9%) |
| G4/5 | 0 | 0 | 0 | 0 | 0 | 0 |
| Maximum G neurotoxicity† | ||||||
| All grades | 1 (25%) | 0 | 0 | 1 (5.9%) | 2 (10%) | 4 (7.7%) |
| ≥G 3 | 1 (25%) | 0 | 0 | 0 | 1 (5%) | 2 (3.8%) |
| HLH | ||||||
| All grades | 0 | 0 | 1 (12.5%) | 1 (5.9%) | 0 | 2 |
| ≥G3 | 0 | 0 | 1 (12.5%) | 1 (5.9%) | 0 | 2 |
| Cytopenias at D30 | ||||||
| ≥G3 Neutropenia | 2 (50%) | 1 (33.3%) | 2 (25%) | 5 (29.4%) | 7 (35%) | 17 (32.7%) |
| ≥G3 thrombocytopenia | 3 (75%) | 3 (100%) | 3 (37.5%) | 5 (29.4%) | 7 (35%) | 21 (40.4%) |
| Maximum grade infections | ||||||
| All grades | 0 | 1 (33.3%) | 7 (87.5%) | 6 (35.3%) | 7 (35%) | 21 (40.4%) |
| ≥G3 | 0 | 0 | 6 (75%) | 3 (17.6%) | 3 (15%) | 12 (23.1%) |
| Hypogammaglobuliemia (≤4 g/L IgG) | ||||||
| All grades | 0 | 0 | 1(12.5%) | 1 (5.9%) | 0 | 2 (3.8%) |
| ≥G3 | 0 | 0 | 0 | 0 | 0 | 0 |
| . | 50 × 106 AUTO3 No Pembro. (N = 4) . | 50 × 106 AUTO3 D14 Pembro. (N = 3) . | 150 × 106-450 × 106 AUTO3 D14 Pembro. (N = 8) . | 150 × 106-450 × 106 AUTO3 D1 Pembro. inpatient (N = 17) . | 150 × 106-450 × 106 AUTO3 D1 Pembro. OPD (N = 20) . | Total (N = 52) . |
|---|---|---|---|---|---|---|
| Maximum grade CRS (ASTCT criteria) | ||||||
| G1 | 1 (25%) | 0 | 2 (25%) | 4 (23.5%) | 4 (20%) | 11 (21.2%) |
| G2 | 0 | 0 | 2 (25%) | 1 (5.9%) | 4 (20%) | 7 (13.5%) |
| G3 | 0 | 0 | 0 | 0 | 1 (5%)∗ | 1 (1.9%) |
| G4/5 | 0 | 0 | 0 | 0 | 0 | 0 |
| Maximum G neurotoxicity† | ||||||
| All grades | 1 (25%) | 0 | 0 | 1 (5.9%) | 2 (10%) | 4 (7.7%) |
| ≥G 3 | 1 (25%) | 0 | 0 | 0 | 1 (5%) | 2 (3.8%) |
| HLH | ||||||
| All grades | 0 | 0 | 1 (12.5%) | 1 (5.9%) | 0 | 2 |
| ≥G3 | 0 | 0 | 1 (12.5%) | 1 (5.9%) | 0 | 2 |
| Cytopenias at D30 | ||||||
| ≥G3 Neutropenia | 2 (50%) | 1 (33.3%) | 2 (25%) | 5 (29.4%) | 7 (35%) | 17 (32.7%) |
| ≥G3 thrombocytopenia | 3 (75%) | 3 (100%) | 3 (37.5%) | 5 (29.4%) | 7 (35%) | 21 (40.4%) |
| Maximum grade infections | ||||||
| All grades | 0 | 1 (33.3%) | 7 (87.5%) | 6 (35.3%) | 7 (35%) | 21 (40.4%) |
| ≥G3 | 0 | 0 | 6 (75%) | 3 (17.6%) | 3 (15%) | 12 (23.1%) |
| Hypogammaglobuliemia (≤4 g/L IgG) | ||||||
| All grades | 0 | 0 | 1(12.5%) | 1 (5.9%) | 0 | 2 (3.8%) |
| ≥G3 | 0 | 0 | 0 | 0 | 0 | 0 |
ASTCT, American Society for Transplantation and Cellular Therapy; D, day; IgG, immunoglobulin G; Pembro, pembrolizumab.
One patient who had no CRS with primary infusion developed G3 CRS (severe hypoxia) with retreatment 1 year later, which happened in a setting of no CAR-T and significant disease burden in lung that had been treated with radiation.
NT grading based on general NT by NCI-CTCAE and CARTOX-10.