Table 2 Summary of toxicities attributed to CAR-T cells*

From: Locoregional delivery of IL-13Rα2-targeting CAR-T cells in recurrent high-grade glioma: a phase 1 trial

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)

  1. *Events of grade 3 or higher, according to the NCI Common Toxicity Criteria, with possible or higher attribution to CAR-T cell administration while on protocol therapy are reported.
  2. ^No events of grade 4 or higher with possible or higher attribution to CAR-T cell administration while on protocol therapy were observed on arms 1, 2 or 5.
  3. **Events (grade 3 or higher) that were probably attributed to CAR-T cell administration while on protocol therapy.