Chimeric antigen receptor (CAR) T cells have demonstrated promising results for cancers
in pre-clinical models and early phase trials. However, some groups have observed
serious adverse events (SAEs) and toxicities attributable to the administration of
CAR T cells, the most clinically significant being cytokine release syndrome (CRS).
In addition, a recent case report described a patient who developed an anaphylaxis
reaction to CAR T cells, ultimately attributed to receipt of multiple doses of cells.
As there are a number of ongoing clinical trials at our institution utilizing CAR
T cells to treat various hematologic and solid malignancies and several patients have
received multiple doses, we performed a retrospective review to assess whether early
or late infusion toxicities were observed with subsequent infusions. We identified
45 of over 200 patients who received more than one dose of CAR T cells between January
2009 and December 2014. We assessed patient characteristics including type of malignancy,
disease status at the time of subsequent infusions, cell product (autologous vs. allogeneic),
presence or absence of prior lymphodepletion, number of infusions, dosing schedule,
and the relationship to development of CRS. Each characteristic was examined for any
correlation to developing a SAE. Our results indicate that at our institution, repeated
CAR T cell infusions are well tolerated, with the majority of grade 3-4 adverse events
being hematologic and electrolyte abnormalities. Furthermore, the majority of SAEs
reported after repeated CAR T cell infusions were attributed as unrelated to the infusion
itself. However, further evaluation of a larger cohort is necessary to determine whether
an association between the timing of repeated infusions and CRS and other SAEs exists.
These findings and our continued evaluation of patients receiving multiple infusions
will help us to ensure the safety of administering multiple doses of CAR T cells in
the future.
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© 2015 Published by Elsevier Inc.