Table 2.

Adverse events.

AEa	Grade 1	Grade 2	Grade 3	Grade 4
Hematologic AEs
Anaemia	4 (19%)	8 (38%)	6 (29%)	0 (0%)
Lymphocyte count decreased	0 (0%)	2 (10%)	3 (14%)	16 (76%)
Lymphocyte count increased	1 (5%)	1 (5%)	0 (0%)	0 (0%)
Neutrophil count decreased	0 (0%)	4 (19%)	14 (67%)	3 (14%)
Platelet count decreased	2 (10%)	8 (38%)	2 (10%)	0 (0%)
Immune system disorders
CRS	11 (52%)	3 (14%)	0 (0%)	0 (0%)
ICANS	3 (14%)	1 (5%)	0 (0%)	0 (0%)
Nervous system disorders
Dizziness	1 (5%)	0 (0%)	0 (0%)	0 (0%)
Headache	1 (5%)	0 (0%)	0 (0%)	0 (0%)
Paraesthesia	1 (5%)	0 (0%)	0 (0%)	0 (0%)
Muscle weakness lower limb	0 (0%)	1 (5%)	0 (0%)	0 (0%)
Psychiatric disorders
Insomnia	1 (5%)	1 (5%)	0 (0%)	0 (0%)
Metabolism and nutrition disorders
Anorexia	2 (10%)	0 (0%)	0 (0%)	0 (0%)
Hypercalcemia	0 (0%)	0 (0%)	0 (0%)	0 (0%)
Hypertriglyceridemia	2 (10%)	3 (14%)	2 (10%)	3 (14%)
Hyperuricemia	0 (0%)	1 (5%)	0 (0%)	1 (5%)
Hyponatremia	1 (5%)	0 (0%)	1 (5%)	0 (0%)
Hypoalbuminemia	3 (14%)	3 (14%)	3 (14%)	3 (14%)
Hypocalcaemia	2 (10%)	6 (29%)	2 (10%)	6 (29%)
Hypokalaemia	4 (19%)	2 (10%)	4 (19%)	2 (10%)
Hypomagnesemia	2 (10%)	0 (0%)	2 (10%)	0 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	1 (5%)	0 (0%)	0 (0%)	0 (0%)
Back pain	1 (5%)	0 (0%)	0 (0%)	0 (0%)
Bone pain	1 (5%)	0 (0%)	0 (0%)	0 (0%)
Flank pain	1 (5%)	0 (0%)	0 (0%)	0 (0%)
Pain in extremity	4 (19%)	0 (0%)	0 (0%)	0 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	7 (33%)	0 (0%)	0 (0%)	0 (0%)
Productive cough	2 (10%)	0 (0%)	0 (0%)	0 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain	0 (0%)	1 (5%)	1 (5%)	0 (0%)
Skin and subcutaneous tissue disorders
Pruritus	1 (5%)	0 (0%)	0 (0%)	0 (0%)
General disorders and administration site conditions
Chills	2 (10%)	0 (0%)	0 (0%)	0 (0%)
Oedema limbs	1 (5%)	0 (0%)	0 (0%)	0 (0%)
Fatigue	7 (33%)	1 (5%)	0 (0%)	0 (0%)
Fever	13 (62%)	1 (5%)	0 (0%)	0 (0%)
Localised oedema	0 (0%)	1 (5%)	0 (0%)	0 (0%)
Non-cardiac chest pain	1 (5%)	0 (0%)	0 (0%)	0 (0%)
Gastrointestinal disorders
Nausea	4 (19%)	0 (0%)	0 (0%)	0 (0%)
Abdominal distension	3 (14%)	0 (0%)	0 (0%)	0 (0%)
Abdominal pain	1 (5%)	0 (0%)	0 (0%)	0 (0%)
Constipation	3 (14%)	0 (0%)	0 (0%)	0 (0%)
Diarrhoea	4 (19%)	0 (0%)	0 (0%)	0 (0%)
Dysphagia	1 (5%)	0 (0%)	0 (0%)	0 (0%)
Mucositis oral	2 (10%)	0 (0%)	0 (0%)	0 (0%)
Paraesthesia	5 (24%)	0 (0%)	0 (0%)	0 (0%)
Vomiting	0 (0%)	1 (5%)	0 (0%)	0 (0%)
Investigations
Activated partial thromboplastin time prolonged	1 (5%)	0 (0%)	0 (0%)	0 (0%)
Blood lactate dehydrogenase increased	8 (38%)	2 (10%)	0 (0%)	0 (0%)
Fibrinogen decreased	0 (0%)	1 (5%)	0 (0%)	0 (0%)
Proteinuria	1 (5%)	0 (0%)	0 (0%)	0 (0%)
Urine output decreased	1 (5%)	0 (0%)	0 (0%)	0 (0%)
White blood cell decreased	1 (5%)	11 (52%)	4 (19%)	5 (24%)

Note: Data are No. (%); All AEs except for CRS were graded according to NCI CTCAE 5.0; CRS was graded according to the criteria of Lee et al.²² and American Society for Transplantation and Cellular Therapy consensus grading.²³.

Abbreviations: SOC, System Organ Class; WBC, white blood cell; CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome.

^aListed are adverse events, which occurred within 30 days post-infusion in the 21 patients, regardless of whether the investigators attributed the events to the CAR-T cell treatment. This table did not report late-onset (with onset more than 30 days post-infusion) adverse events, including a Pneumocystis jirovecii pneumonia nine months after infusion in one patient.