Table 1 Overview of case characteristics, tumour sample test results, and causality assessment.

From: Secondary malignancy of T-cell origin after CAR T-cell therapy: EMA’s conclusions from the evaluation of 38 suspected cases

CAR T-cell therapy

Age (years)

Sex

Time to onset (months)

MedDRA PT classification

Tumour sample tested

CAR transgene test result

Causality assessment

BCMA directed

LVV

N = 9 cases

47–71

1 case unknown

4 Female

4 Male

1 Unknown

2–21

• Anaplastic T-cell lymphoma n = 1

• Enteropathy-associated T cell lymphoma n = 1

• Gastrointestinal T-Cell Lymphoma n = 1

• Large granular lymphocyte (LGL) leukaemia n = 1

• Peripheral T-Cell Lymphoma n = 3

• T-cell lymphoma n = 2

Yes n = 7

No n = 2

Positive n = 5

Negative n = 2

Probable: n = 5

Unlikely n = 2

Conditional n = 1

Not assessable n = 1

CD19-directed LVV

N = 13 cases

46–75

5 cases unknown

6 Female

5 Male

2 Unknown

1–35

2 cases unknown

• Peripheral T-Cell Lymphoma n = 3

• Cutaneous T-cell lymphoma n = 1

• Large granular lymphocyte (LGL) leukaemia n = 1

• T-cell lymphoma n = 8

Yes n = 8

No n = 5

Positive n = 2

Negative n = 6

Probable n = 2

Possible n = 5

Unlikely n = 6

CD19-directed γ-RVV

N = 16 cases

29–64

6 cases unknown

7 Female

7 Male

2 Unknown

2–57

1 case unknown

• Angioimmunoblastic T-cell lymphoma n = 1

• Lymphoproliferative Disorder n = 1

• Large granular lymphocyte (LGL) leukaemia n = 5

• Lymphocytic leukaemia n = 2

• T-cell lymphoma n = 7

Yes n = 4

No n = 12

Negative n = 4

Possible n = 8

Unlikely n = 4

Not assessable n = 4

  1. BCMA directed LVV B-cell maturation antigen directed lentiviral vector (i.e., idecabtagene vicleucel and ciltacabtagene autoleucel), CD19-directed LVV cluster of differentiation 19 directed lentiviral vector (i.e., lisocabtagen maraleucel, tisagenlecleucel), CD19-directed RVV cluster of differentiation 19 directed γ-retroviral vector (i.e., axicabtagene ciloleucel, brexucabtagene autoleucel).
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