Table 2.
Adverse among All 32 Treated Patients.
| Adverse events | Any | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 |
|---|---|---|---|---|---|---|
| Any | 30 (93.8) | 0 | 1 (3.1) | 7 (21.9) | 21 (65.6) | 1 (3.1) |
| CRS | 29 (90.6) | 14 (43.8) | 6 (18.7) | 5 (15.6) | 3 (9.4) | 1 (3.1) |
| ICANS | 5 (15.6) | 1 (3.1) | 0 | 4 (12.5) | 0 | 0 |
| Haematological toxicity | ||||||
| Neutropenia | 26 (81.3) | 0 | 0 | 4 (12.5) | 22 (68.8) | 0 |
| Thrombocytopenia | 26 (81.3) | 1 (3.1) | 8 (25.0) | 8 (25.0) | 9 (28.1) | 0 |
| Anaemia | 30 (93.8) | 2 (6.3) | 10 (31.3) | 14 (43.8) | 4 (12.5) | 0 |
| General disorders and administration site conditions | ||||||
| Pyrexia | 29 (90.6) | 10 (31.3) | 14 (43.8) | 4 (12.5) | 1 (3.1) | 0 |
| Fatigue | 14 (43.8) | 10 (31.3) | 4 (12.5) | 0 | 0 | 0 |
| Chills | 13 (40.6) | 11 (34.4) | 2 (6.3) | 0 | 0 | 0 |
| Skin rash | 2 (6.3) | 1 (3.1) | 1 (3.1) | 0 | 0 | 0 |
| Pain | 2 (6.3) | 2 (6.3) | 0 | 0 | 0 | 0 |
| Laboratory tests | ||||||
| ALT increased | 2 (6.3) | 0 | 1 (3.1) | 1 (3.1) | 0 | 0 |
| AST increased | 3 (9.4) | 0 | 2 (6.3) | 1 (3.1) | 0 | 0 |
| T-BIL increased | 3 (9.4) | 2 (6.3) | 1 (3.1) | 0 | 0 | 0 |
| Creatinine increased | 7 (21.9) | 2 (6.3) | 2 (6.3) | 1 (3.1) | 1 (3.1) | 1 (3.1) |
| APTT prolonged | 12 (33.3) | 6 (18.7) | 4 (12.5) | 2 (6.3) | 0 | 0 |
| Disorders of the Cardiac, respiratory system, renal system, and Gastrointestinal system | ||||||
| Hypotension | 13 (40.6) | 4 (12.5) | 1 (3.1) | 7 (21.9) | 1 (3.1) | 0 |
| Hypoxia | 7 (21.9) | 3 (9.4) | 0) | 4 (12.5) | 0 | 0 |
| Heart failure | 2 (6.3) | 0 | 0 | 0 | 2 (6.3) | 0 |
| Dyspnoea | 2 (6.3) | 0 | 1 (3.1) | 1 (3.1) | 0 | 0 |
| Acute kidney injury | 2 (6.3) | 0 | 0 | 0 | 1 (3.1) | 1 (3.1) |
| Nausea | 7 (21.9) | 3 (9.4) | 4 (12.5) | 0 | 0 | 0 |
| Vomiting | 8 (25.0) | 5 (15.6) | 3 (9.4) | 0 | 0 | 0 |
| Abdominal distention | 4 (12.5) | 2 (6.3) | 1 (3.1) | 1 (3.1) | 0 | 0 |
| Diarrhoea | 4 (12.5) | 4 (12.5) | 0 | 0 | 0 | 0 |
| Infections | ||||||
| Lung infection | 5 (15.6) | 0 | 0 | 5 (15.6) | 0 | 0 |
| Septicaemia | 2 (6.3) | 0 | 0 | 2(6.3) | 0 | 0 |
| Neurologic events | ||||||
| Delirium | 2 (6.3) | 0 | 1 (3.1) | 1 (3.1) | 0 | 0 |
| Epilepsy | 2 (6.3) | 0 | 1 (3.1) | 1 (3.1) | 0 | 0 |
| Somnolence | 2 (6.3) | 0 | 1 (3.1) | 1 (3.1) | 0 | 0 |
| Cognitive disturbance | 3 (9.4) | 0 | 1 (3.1) | 2 (6.3) | 0 | 0 |
| Speech disorder | 1 (3.1) | 0 | 1 (3.1) | 0 | 0 | |
Severity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. Cytokine release syndrome and neurologic events were graded according to the American Society for Blood and Marrow Transplantation (ASBMT) consensus. Regarding the grade 5 events, one patient died from acute kidney injury related to CAR T therapy. CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome; ALT, alanine aminotransferase; AST, aspartate aminotransferase; T-BIL, total bilirubin; APTT, activated partial thromboplastin time.