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Risk of secondary T-cell malignancy after CAR T-cell therapy

https://doi.org/10.1136/dtb.2025.000023

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    Key learning points

    • Secondary malignancies of T-cell origin, including lymphomas and leukaemias, have been reported within weeks or years following treatment with chimeric antigen receptor (CAR) T-cell therapy.

    • The risks are associated with all currently licensed B-cell maturation antigen (BCMA)-directed or CD19-directed CAR T-cell medicines.

    • Patients receiving these treatments should be monitored lifelong for secondary T-cell malignancies.

    Patients who have receieved BCMA-directed or CD19-directed chimeric antigen receptor (CAR) T-cell therapy should receive life-long monitoring for secondary T-cell malignancies.1 2

    Overview

    The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have identified a risk of secondary malignancies of T-cell origin following treatment with CAR T-cell …

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    Footnotes

    • Provenance and peer review Commissioned; internally peer reviewed.