After receiving the engineered cells, she experienced no fevers or other signs
of cytokine release syndrome (CRS), a condition that has been observed in other patients undergoing CTL019.
Not exact matches
CAR - T treatments, including competing products from Novartis rivals Kite Pharma and Juno Therapeutics, come with the risk
of potentially deadly side effects such as
cytokine -
release syndrome (CRS), in which a glut
of T - cell - assisting
cytokines can cause high fever, low blood pressure, and problems with lung oxygenation.
But while the technology itself is undeniably exciting, some companies, like Juno Therapeutics, have been struggling with the reality
of dangerous side effects including
cytokine release syndrome and brain swelling during trials.
About half
of the patients in a Kymriah study got
cytokine -
release syndrome, a response to the reprogrammed cells running loose in the body.
(The FDA on Wednesday expanded the approval
of Actemra, a rheumatoid - arthritis drug that can also treat
cytokine -
release syndrome.)
All 10 patients who received the CTL119 cells experienced mild
cytokine release syndrome (CRS), a known potentially lethal type
of toxicity, within a few days after receiving their infusions; however, none required treatment with tocilizumab, an immunosuppressant drug that blocks the effects
of the inflammatory
cytokine IL - 6.
What's more, none
of the patients experienced macrophage activate
syndrome or
cytokine release syndrome, an infusion reaction observed in other gene therapy trials characterized by fever, nausea, chills, hypotension or a rash.
The therapy was found to have an acceptable safety profile in all patients, with no clinical or laboratory signs
of systemic
cytokine release syndrome, a potentially serious toxicity that has been observed in other CAR trials.
Four
of the eight children experienced
cytokine release syndrome.
All six had
cytokine release syndrome (CRS), from which they recovered after treatment with tocilizumab, an immunosuppressant drug that blocks the effects
of the inflammatory
cytokine IL - 6.
The team provided the most comprehensive data yet on
cytokine release syndrome, neurological toxicities and infections after infusion
of a CAR T - cell product, laying the groundwork for reducing the risk
of the most severe toxic effects.
In ZUMA - 1, 12 %
of the patients had a grade 3 or higher
cytokine release syndrome and that is essentially a patient requiring mechanical ventilation or needing treatment with a high - dose vasopressor.
Unfortunately, those patients may be unlikely to make it through the 17 days we need to manufacture the CAR T cells, and it is less likely that they will be able to tolerate the severe
cytokine release syndrome or get through the other acute toxicities
of therapy.
Cytokine release syndrome occurs when many
cytokines get
released into the serum upon CAR T - cell injection; patients can get high fevers and sometimes hypertension, and occasionally there is a need for mechanical ventilation or administration
of vasopressors, but that is rare.