Table 2.
List of adverse reactions
| Adverse reactions | Grade | Adverse reactions | Grade | ||||
|---|---|---|---|---|---|---|---|
| I–II | III | IV | I–II | III | IV | ||
| CRS | 1 | 0 | 0 | Constitutional | |||
| Graft-versus-host disease | 0 | 0 | 0 | Anorexia | 1 | 0 | 0 |
| Neurological toxicity | 0 | 0 | 0 | Asthenia | 12 | 1 | 0 |
| Hematological toxicity | Fever/chillsa | 2 | 0 | 0 | |||
| Neutropenia | 3 | 5 | 29 | Insomnia | 2 | 0 | 0 |
| Lymphopenia | 0 | 0 | 37 | Somnolence | 0 | 1 | 0 |
| Thrombocytopenia | 23 | 4 | 6 | Gastrointestinal | |||
| Anemia | 19 | 18 | 0 | Diarrhea | 4 | 0 | 0 |
| Petechia/other bleeding | 1 | 0 | 0 | Hemorrhoids | 3 | 0 | 0 |
| Laboratory values | Ileus | 0 | 2 | 0 | |||
| Elevated creatinine | 4 | 0 | 0 | Mucositis | 4 | 0 | 0 |
| Elevated LFTs | 9 | 1 | 0 | Nausea/vomiting | 8 | 0 | 0 |
| Elevated CRP | 2 | 0 | 0 | Cardiovascular | |||
| Elevated ferritin | 5 | 0 | 0 | Chest pain | 2 | 0 | 0 |
| Hyperglycemia | 1 | 0 | 0 | Dysrhythmia | 7 | 0 | 0 |
| Elevated LDH | 3 | 0 | 0 | Hypertension | 1 | 0 | 0 |
| Hypomagnesemia | 1 | 0 | 0 | Hypotension | 5 | 0 | 0 |
| Respiratory | Edema/fluid overload | 2 | 1 | 0 | |||
| Dyspnea | 1 | 0 | 0 | Miscellaneous | |||
| Pleural effusion | 0 | 1 | 0 | Anxiety | 3 | 0 | 0 |
| Pneumonitis | 1 | 1 | 0 | Headache/dizziness | 2 | 0 | 0 |
| Infection | Muscle/bone pain | 4 | 0 | 0 | |||
| Bacterial infection | 3 | 1 | 0 | Paresthesia | 4 | 0 | 0 |
| Viral infection | 4 | 3 | 0 | Rash/skin discoloration | 4 | 0 | 0 |
| Febrile neutropeniab | 0 | 4 | 0 | Other | 2 | 0 | 0 |
LFT, liver function test; CRP, C-reactive protein; LDH, lactate dehydrogenase.
The table includes all side effects from the time of infusion until day +40, irrespective of their attribution to the CAR19/IL-15 NK cell therapy. Abnormalities due to the original disease were not captured.
aOne patient had isolated chills; one patient had fever and was classified as CRS corresponding to the reported CRS case.
bOne patient had fever related to MRSA pneumonia; one patient had a fever that resolved within 24 h of starting antibiotics; one patient had two neutropenic fever episodes (the first episode occurred before the cells were given and the second episode was a recurrence of this fever and did not fit criteria for CRS).