Treatment-emergent AEs
| TEAEs by maximum severity (N=16) | ||||
| AE | All grades | ≥grade 3 | ||
| No. | % | No. | % | |
| Patients with any AE | 16 | 100 | 15 | 93.8 |
| AEs of special interest | ||||
| Cytokine release syndrome | 13 | 81.3 | 1 | 6.3 |
| ICANS | 2 | 12.5 | 0 | 0 |
| Blood and lymphatic system disorders | ||||
| Neutropenia | 14 | 87.5 | 13 | 81.3 |
| Lymphopenia | 12 | 75 | 12 | 75 |
| Anemia | 12 | 75 | 8 | 50 |
| Thrombocytopenia | 10 | 62.5 | 8 | 50 |
| Leukopenia | 5 | 31.3 | 4 | 25 |
| Gastrointestinal disorders | ||||
| Gastrointestinal hemorrhage | 1 | 6.3 | 1 | 6.3 |
| Nausea | 7 | 43.8 | 0 | 0 |
| Diarrhea | 5 | 31.3 | 0 | 0 |
| Constipation | 3 | 18.8 | 0 | 0 |
| General disorders and administration site conditions | ||||
| Fatigue | 5 | 31.3 | 1 | 6.3 |
| Fever | 5 | 31.3 | 0 | 0 |
| Chills | 4 | 25 | 0 | 0 |
| Edema peripheral | 3 | 18.8 | 0 | 0 |
| Infections and infestations | ||||
| Pneumonia | 2 | 12.5 | 1 | 6.3 |
| Candida infection | 1 | 6.3 | 1 | 6.3 |
| Infection | 1 | 6.3 | 1 | 6.3 |
| Urinary tract infection | 1 | 6.3 | 1 | 6.3 |
| Injury, poisoning and procedural complications | ||||
| Upper limb fracture | 1 | 6.3 | 1 | 6.3 |
| Fall | 3 | 18.8 | 0 | 0 |
| Investigations | ||||
| Blood alkaline phosphatase increased | 3 | 18.8 | 1 | 6.3 |
| Aspartate aminotransferase increased | 3 | 18.8 | 0 | 0 |
| Alanine aminotransferase increased | 3 | 18.8 | 0 | 0 |
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 2 | 12.5 | 1 | 6.3 |
| Hypoalbuminemia | 3 | 18.8 | 0 | 0 |
| Hypokalaemia | 3 | 18.8 | 0 | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Muscular weakness | 1 | 6.3 | 1 | 6.3 |
| Neoplasm benign, malignant and unspecified (including cysts and polyps) | ||||
| Tumor pain | 1 | 6.3 | 1 | 6.3 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnea* | 1 | 6.3 | 1 | 6.3 |
| Epistaxis | 2 | 12.5 | 1 | 6.3 |
| Hypoxia | 3 | 18.8 | 0 | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Rash | 5 | 31.3 | 1 | 6.3 |
| Vascular disorders | ||||
| Hypertension | 1 | 6.3 | 1 | 6.3 |
| Hypotension | 3 | 18.8 | 0 | 0 |
All TEAEs with grade 1 and 2 occurring in at least three patients (incidence ≥18.8%) and additionally ICANS and all events with grades 3–5 regardless of relatedness to trial treatment are presented. AEs were coded using MedDRA. Maximum severity was graded according to NCI-CTCAE, V.5.0. Grades for CRS and ICANS were determined according to CAR-T cell therapy-associated toxicity (CARTOX) criteria.17 Patients were counted only once per AE and severity classification.
*The patient died from dyspnea, which was not considered related to any trial drug.
AE, adverse event; CRS, cytokine release syndrome; ICANS, immune-effector cell-associated neurotoxicity syndrome; MedDRA, Medical Dictionary for Regulatory Activities; NCI-CTCAE, National Cancer Institute–Common Terminology Criteria for Adverse Events; TEAEs, treatment-emergent AEs.