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Table 2 Adverse events within 2 months after infusion

From: A bispecific CAR-T cell therapy targeting BCMA and CD38 in relapsed or refractory multiple myeloma

Adverse event

Any Grade

Grade 3

Grade 4

Number of patients (percent)

   

CRS per Lee Criteria

20 (87)

2 (9)

3 (13)

CRS per ASTCT Consensus*

20 (87)

4 (17)

0

CRES

0

0

0

Hematologic

   

Leukopenia

20 (87)

6 (26)

13 (57)

Neutropenia

22 (96)

3 (13)

17 (74)

Anemia

10 (43)

3 (13)

0

Thrombocytopenia

14 (61)

4 (17)

7 (30)

Pulmonary

   

Pleural effusion

3 (13)

1 (4)

0

Pulmonary edema

1 (4)

1 (4)

0

Gastrointestinal

   

Diarrhea

3 (13)

0

0

Vomiting

1 (4)

0

0

Hepatic

   

AST increase

8 (35)

3 (13)

0

ALT increase

10 (43)

4 (17)

1 (4)

Nephritic

   

Creatinine increase

3 (13)

0

1 (4)

Infection

   

Oral candidiasis

1(4)

0

0

Upper respiratory tract infection

2 (9)

0

0

Lung infection

1 (4)

1 (4)

0

Digestive infection

1 (4)

1 (4)

0

Others

   

Fever

19 (83)

2 (9)

0

Hypotension

1 (4)

0

0

Hypoxemia

3 (13)

1 (4)

1 (4)

Sinus tachycardia

8 (35)

1 (4)

0

Hypocalcemia

15 (65)

2 (9)

1 (4)

Hypokalemia

6 (26)

0

0

Hyponatremia

5 (22)

0

0

  1. CRS, cytokine release syndrome; CRES, CAR T-cell-related encephalopathy syndrome; ALT, alanine aminotransferase; AST, aspartate aminotransferase
  2. *CRS was downgraded per ASTCT consensus for the following reasons: patient 5 for grade 3 hepatotoxicity, patient 7 for grade 4 coagulopathy, patient 9 for grade 4 nephrotoxicity and patient 19 for emergency thoracentesis due to fatal pleural effusion