Table 2 Adverse events, CRS, and ICANS.

From: Next-day manufacture of a novel anti-CD19 CAR-T therapy for B-cell acute lymphoblastic leukemia: first-in-human clinical study

Variable

Total (N = 25)

Any grade

Grade 1–2

Grade ≥3

number of patients (percent)

Adverse eventsa

Any

25 (100)

25 (100)

25 (100)

Hematological

 Leukopenia

22 (88)

0

22 (88)

 Anemia

19 (76)

6 (24)

13 (52)

 Lymphopenia

19 (76)

0

19 (76)

 Thrombocytopenia

19 (76)

5 (20)

14 (56)

 Neutropenia

16 (64)

2 (8)

14 (56)

Gastrointestinal

 Diarrhea

9 (36)

9 (36)

0

 Nausea

8 (32)

8 (32)

0

Other

 Anorexia

13 (52)

13 (52)

0

 Hypokalemia

12 (48)

10 (40)

2 (8)

 Hypocalcemia

12 (48)

12 (48)

0

 Fatigue

11 (44)

11 (44)

0

 Hypoalbuminemia

9 (36)

8 (32)

1 (4)

 Hyponatremia

9 (36)

9 (36)

0

 Headache

9 (36)

9 (36)

0

 Fever

8 (32)

8 (32)

0

 Hypomagnesemia

7 (28)

7 (28)

0

 Elevated ALT

6 (24)

6 (24)

0

 Total bile acid increased

5 (20)

4 (16)

1 (4)

 Hypophosphatemia

5 (20)

5 (20)

0

CRS

24 (96)

18 (72)

6 (24)

ICANS

7 (28)

0

7 (28)

  1. aListed adverse events are not designated as symptoms of CRS or ICANS and occurred in at least 20% of patients.
  2. ALT alanine transaminase, AST aspartate transaminase, CRS cytokine release syndrome, ICANS immune effector cell-associated neurotoxicity syndrome.
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