Table 2 Summary of toxicities attributed to CAR-T cells*
CTCAE v4.0 AE category | AE detail | Arms 1 and 2 (ICT) N = 20 | Arm 3 (ICV) N = 11 | Arm 4 (Dual) N = 12 | Arm 5 (Dual Tn/mem) N = 22 | ||
|---|---|---|---|---|---|---|---|
Grade 3^ No. (%) | Grade 3 No. (%) | Grade 4 No. (%) | Grade 3 No. (%) | Grade 4 No. (%) | Grade 3^ No. (%) | ||
Gastrointestinal disorders | Nausea | 0 | 1 (9) | 0 | 2 (17) | 0 | 0 |
Vomiting | 1 (5) | 0 | 0 | 2 (17) | 0 | 0 | |
General disorders and administration site conditions | Fatigue | 1 (5) | 1 (9) | 0 | 0 | 0 | 0 |
Gait disturbance | 0 | 0 | 0 | 1 (8) | 0 | 0 | |
Investigations | Alanine aminotransferase increased | 0 | 0 | 0 | 0 | 0 | 1 (5) |
Lymphocyte count decreased | 2 (10) | 0 | 0 | 0 | 0 | 0 | |
Metabolism and nutrition disorders | Hyponatremia | 0 | 0 | 0 | 0 | 0 | 1 (5) |
Musculoskeletal and connective tissue disorders | Back pain | 0 | 0 | 0 | 0 | 0 | 1 (5) |
Neck pain | 0 | 0 | 0 | 0 | 0 | 1 (5) | |
Generalized muscle weakness | 0 | 0 | 0 | 1 (8) | 0 | 0 | |
Nervous system disorders | Ataxia | 0 | 0 | 0 | 0 | 0 | 1 (5)** |
Depressed level of consciousness | 0 | 1 (9) | 0 | 0 | 0 | 0 | |
Dysphasia | 1 (5) | 1 (9) | 0 | 0 | 0 | 0 | |
Edema cerebral | 0 | 0 | 1 (9) | 0 | 1(8) | 0 | |
Encephalopathy | 0 | 0 | 0 | 1 (8)** | 0 | 0 | |
Headache | 3 (15) | 1 (9) | 0 | 3 (25) | 0 | 2 (9) | |
Hydrocephalus | 0 | 1 (9) | 0 | 0 | 0 | 1 (5) | |
Nervous system disorders—left side Hemiparesis | 0 | 0 | 0 | 1 (8) | 0 | 0 | |
Peripheral motor neuropathy | 0 | 1 (9) | 0 | 0 | 0 | 0 | |
Vascular disorders | Hypertension | 2 (10) | 4 (36) | 0 | 1 (8) | 0 | 2 (9) |