Agilent - Breakthroughs in Immunotherapy- 2019 - 20

Breakthroughs in Immunotherapy

cell therapy may adversely affect a patient
is still progressing.
The product's risk profile dictates what
safety requirements need to be assessed.
Allogeneic products pose a graft versus
host disease (GvHD) risk. Another risk
is cytokine release syndrome (CRS),
a systemic inflammatory response
syndrome that arises as a complication
due to infections, which may also occur
when administering adoptive T cell therapies. These are difficult to predict due to
the inherent variation between patient
immune responses.
Since cell therapies are being used to treat
life threatening illnesses such as cancer,
the risk of toxicity is often outweighed by
the potential for improved patient survival.
There is a difference between toxicity
that has no benefit to the patient and
therapeutic toxicity, which can be an indication that the cells are actually killing the
tumor cells.. "What we really are controlling for is unexpected side effects," states

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Dr. Lowdell. "Indeed, you might end up
screening out the effective agent because
part of the adverse effect may be the therapeutic response."
"When we look at potency in more patientlike in vitro models, we are looking for
predictive signals that can be correlated
with clinical trial observations," says Dr.
Roy. "In terms of CAR-T cells, we are
beginning to understand why some cases
of neurotoxicity and CRS happen, but do
not yet have the detailed understanding to
predict the outcomes of these therapies."
"Twenty to thirty percent of patients are
not helped by CAR-T therapy. Our center
and others are starting to look into the
many unanswered questions. It goes
back to quality attributes," continues Dr.
Roy. "What are the properties of the most
effective, potent and safe cell therapies?
We have learned a lot from the biologics
era. As a field, we need to think about
the correlative, predictive parameters of
potency assays early on." n
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Agilent - Breakthroughs in Immunotherapy- 2019

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