Table 2.
Adverse events.
| AEs | Grade 1 | Grade 2 | Grade 3 | Grade 4 |
|---|---|---|---|---|
| Hematologic AEs | ||||
| Anemia | 0 (0%) | 0 (0%) | 4 (33%) | 0 (0%) |
| Febrile neutropenia | 0 (0%) | 0 (0%) | 3 (25%) | 0 (0%) |
| Lymphocyte count decreased | 0 (0%) | 0 (0%) | 1 (8%) | 9 (75%) |
| Neutrophil count decreased | 0 (0%) | 0 (0%) | 1 (8%) | 11 (92%) |
| Platelet count decreased | 0 (0%) | 1 (8%) | 1 (8%) | 5 (42%) |
| White blood cell decreased | 0 (0%) | 0 (0%) | 2 (17%) | 10 (83%) |
| Immune system disorders | ||||
| CRS | 3 (25%) | 1 (8%) | 0 (0%) | 0 (0%) |
| Hypogammaglobulinemia | 5 (42%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Nervous system disorders | ||||
| Dizziness | 1 (8%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Metabolism and nutrition disorders | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Hyperuricemia | 2 (17%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Hypoalbuminemia | 0 (0%) | 1 (8%) | 0 (0%) | 0 (0%) |
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 1 (8%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Pain in extremity | 2 (17%) | 1 (8%) | 0 (0%) | 0 (0%) |
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 3 (25%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Dyspnea | 1 (8%) | 0 (0%) | 0 (0%) | 0 (0%) |
| General disorders and administration site conditions | ||||
| Chills | 1 (8%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Edema limbs | 2 (17%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Fatigue | 1 (8%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Fever | 3 (25%) | 1 (8%) | 0 (0%) | 0 (0%) |
| Pain | 4 (33%) | 1 (8%) | 0 (0%) | 0 (0%) |
| Gastrointestinal disorders | ||||
| Abdominal pain | 1 (8%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Flatulence | 1 (8%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Nausea | 3 (25%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Vomiting | 1 (8%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Infections and infestations | ||||
| Urinary tract infection | 0 (0%) | 1 (8%) | 0 (0%) | 0 (0%) |
| Vascular disorders | ||||
| Hypotension | 1 (8%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Cardiac disorders/Respiratory, thoracic and mediastinal disorders | ||||
| Chest tightness | 1 (8%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Investigations | ||||
| Blood lactate dehydrogenase increased | 6 (50%) | 0 (0%) | 0 (0%) | 0 (0%) |
Note: Data are No (%); All AEs except for CRS and ICANS were graded according to NCI CTCAE 5.0; CRS and ICANS was graded according to the criteria of American Society for Transplantation and Cellular Therapy consensus grading. Abbreviations: CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome. All adverse events regardless of relationship with CAR-DNT cell treatment, which occurred within 30 days post-infusion in the 12 patients, are shown in the table.