There’s eight steps in the process to
get CAR T-cells. You have to identify the patient first. And then you have to make
sure that that’s the appropriate therapy for the patient. You need to have a line placed in order
for us to collect your T cells, so it’s an operative procedure where we put a
large-bore IV in a big vein. With the apheresis procedure we have a
prescribed dose of cells we want to collect. The apheresis machine is a cell
separator so it actually can figure out where your T lymphocytes are, take out
those and return all the other blood products. So it’s a centrifuge – it spins
out. At the end of one day’s collection we’ll look at those cells, we’ll do a
count, and if that meets that criteria then we’re done. If not, we’ll do apheresis on day two. Once the apheresis is complete we’ll send the cells over to the Dana-Farber cell manipulation facility and they are responsible for freezing those cells, packaging them, and getting them ready
for transport to Novartis. The estimated time that they give us is 24 to 28 days. Once Novartis releases them they will ship them back to us frozen to the cell manufacturing facility where they will stay frozen in a liquid nitrogen tank until the doctors say that we’re good to give it back. Then we’re gonna bring you
back into the hospital when the cells are here, We’re gonna check to make sure you’re
still well enough to get them. The patients would get five days of
chemotherapy conditioning just to wipe out any bad cells that are still
circulating around and make room for the new T cells. And then the Kymriah gets
infused – it gets infused over a half an hour. It’s very small – it looks like a bag of
blood, about 50cc – so less than two ounces. After your infusion there is a
risk that you could develop cytokine release syndrome which is a known risk for any CAR T cell product. And you could get quite ill with that – we may need to heighten our level of care for you and you may need to get transferred to the intensive care unit. We work in conjunction with our intensivists up in the intensive care unit so that they are collaborating on this with us, they know
who the patient is, when they’re coming in… they’re well aware if you need to
go somebody is expecting you. And then you’ll be observed in the intensive care
unit until you’re stable, and then you’ll come back downstairs to the bone marrow transplant unit. The window to develop that cytokine release is three to 22 days post infusion. If we kept you until day 35 you’re beyond the window and it’s safe to go home.