Updates to Wearable Tech and Early Detection of CRS in Patients | Sridevi Rajeeve, MD | ASH 2023

Hi, my name is Sridevi Rajeev and I'm a multiple myeloma and cell therapy physician at the Memorial Sloan-Kerring Cancer Center in New York City. I thank Health Tree for giving this opportunity today to talk about our exciting project that we are presenting at the American Society of Hematology 2023 meeting held in sunny San Diego. So in our project, we are actually looking at whether the use of wearable devices for detecting cytokine release syndrome in patients undergoing chimeric antigen receptor T cell or CARP T cell therapy is feasible at all. And we have some exciting data that I'm presenting as an oral presentation on Monday, December the 11th. So these are some abbreviated results of that which I'm excited to share with Health Tree. Now we designed an investigative initiated trial at the Mount Sinai Hospital where I was doing my fellowship training with two questions in mind. A was can we predict cytokine release syndrome in patients who are getting CARP T using wearable devices? Can we detect them earlier and can we use some of this data to predict them? We were also looking at whether there are some blood biomarkers or proteins that are elevated in the blood before the onset of cytokine release syndrome, which we can study and then use those proteins to also predict whether patients are at risk for cytokine release syndrome. The overall goal of trying to predict and detect cytokine release syndrome early is with the hope that we can take CARP T therapy to the outpatient setting one day and we hope that that one day will come soon. So at this meeting we are presenting the results of the wearables portion of the investigative initiated trial. We screened 34 patients. We had 28 patients enroll and actively complete monitoring while they were admitted for CARP T therapy in the hospital. So while they were admitted, we put the wearable device on them and we continuously captured vital signs data and we looked at them retrospectively, meaning after the monitoring was done. So what we found was this. When compared to standard of care, which is nursing recorded vital signs, which is what happens in the hospital when you're admitted and nurses take your vital signs and then we detect changes consistent with cytokine release syndrome, which includes fever, low oxygen saturation or hypoxia or low blood pressure or hypotension. The wearable device that was placed on the patients actually detected signs and symptoms of cytokine release syndrome in every single instance that nursing recorded cytokine release syndrome. And in addition to detecting cytokine release syndrome every single time, it also detected CRS much earlier than standard of care. So we analyze this data by two methods. One is by creating a threshold of 38 degrees Celsius, which is actually the definition of fever by the American Society of Transplantation and Cellular Therapy. So when we had the device pick up signals when temperatures breached 38 degrees Celsius, we found that the device was actually detecting fever around 22 minutes earlier than nurses first recorded fever. We then looked at another method to detect an earlier elevation temperature and that's by creating an individualized threshold for temperature for patients, meaning we take each patient's baseline temperature and when temperatures breached two times the standard deviation above and when the wearable detected this temperature elevation, we called it device detected cytokine release syndrome. And to our surprise, the device detected these changes using this threshold method 184 minutes before nurses first recorded signs and symptoms of CRS. So overall, between these two methods, we saw that the device was continuously capturing vital signs and also detecting cytokine release syndrome as early as almost three hours before nurses first recorded fever. So what are the clinical implications of this? This means that if at all we were to take patients outpatient and patients were to be monitored at home after receiving CAR T's in the clinic, what we can do is actually have them wear the wearable device continuously at home and monitor any changes in vital signs with our command center. And from when we first start seeing sustained changes in vital signs, we can call them back to the clinic or back to the hospital, evaluate them and give them the treatment they need and then once the symptoms are there, they can go back home, thereby avoiding the long days of inpatient stay that is now the standard of care in CAR T therapy. So our project is nearing completion. We are almost completing and rolling every single patient we want and we hope to write up this project very, very soon. But these results are highly encouraging and we think that there's a strong future of taking CAR T's to the outpatient setting by continuous vital signs monitoring using wearable devices. The latter part of our investigator-initiated trial using blood biomarkers to predict cytokine to Prilly syndrome is actively being studied and we hope to complete that project soon. And our overarching goal is to have the CRS prediction index using both vital sign data from wearables, blood data from all the cytokine data that we are collecting and overall build a prediction index in which we can actually, with the help of AI, predict which patient is at the highest risk for cytokine release syndrome and thereby those patients can be monitored in the hospital and those patients who are deemed to be a lower risk can be kept at home and be monitored after CAR T. So I thank Health Tree for this opportunity. I'm excited to talk more about this project in the coming months and get this technology out to all patients. Thank you.