Kite Pharma today announced that their anti-CD19 CAR-T trial left one patient dead in late April this year. During a conference call, Arie S. Belldegrun, CEO of Kite Pharma explained in detail what had happened:
“In late April, we learned that this event in a very sick patients with explosive expulsive disease, meaning a rapidly progressive and symptomatic disease. This patient has shown inadequate responses to both first and second line therapies and those involved in the care cell CAR T therapy was the best and only remaining option. The treatment course was complicated by CRS and neurologic event and despite best attempts, the patient developed multi-organ failure and then fatal cerebral edema.”
… “So this patient had a refractory non-Hodgkin’s lymphoma, at the time of enrollment, he had as I said explosive disease that was rapidly progressing and having a lot of symptoms from the tumor, that includes having fever, and there were lot of concerns about underline infection, however, patients repeated blood culture impact and viral culture came back negative, patient had worsening liver functions, which was attributed to this progressive disease and also during the
initial chemo conditioning therapy, patient developed a new onset malignant perfusion.
So, in all patient had a pretty rapidly progressing disease and also as part of additional work-up, we have generated initial blood and cerebral spinal fluid cytokine level and this patient had one of the highest level of certain cytokines
that we have ever seen in all ZUMA-1 patients, so all those things indicate that patients base line underlying inflammatory conditions were extremely at high level.”
It seems that this patient was already very sick to start with. But even as cell therapies become more mature, this incidence makes it clear that they still lack the desired controllability.
Saftely switches, like the one developed by Bellicum might be part of the solution for that problem.