How long will a patient remain in the hospital after re-infusion?

How long will a patient remain in the hospital after reinfusion? A patient who's receiving CAR T cells, we consider them as being admitted. The first day is the day they receive CAR T cells. Then starts a period of monitoring to see whether the patient develops cytokine release syndrome or if they develop neurotoxicity. We observe patients for at least 10 to 14 days because this has been shown in studies to be the time in which patients do develop CRS and neurotoxicity or any kind of infections. We monitor to see when the blood counts are going down and until they recover. Usually the trend of recovery of blood cells is usually by the 10th or 12th day. So that is the trigger for us as physicians or as providers to realize that it's ready for, it's time for you to go home. When we know that there is no fever, you're feeling okay and your blood counts have recovered, that is the time when you're ready for discharge. After the initial admission, we keep a very close eye on CAR T recipients even after they go home. So initially they will be seen in the clinic, sometimes even twice a week and certainly a minimum of once a week for the first few weeks. And then it varies from patient to patient based on how well their blood counts recover and whether they experience some other complications. It's fairly typical that after CAR T cells, blood counts have a slow recovery. So some patients would go home and still require blood transfusions, platelet transfusions or growth factors such as neupogen or granics, one of those shots that make the white blood cell count recover faster. Those do require quite significant monitoring, which is the reason why we see patients frequently. In most patients, these issues will resolve within a few weeks. Occasional patients who've had a lot of prior therapy for their disease may require several months of this type of frequent monitoring and it may take them a longer time to go back to their normal life. But in general, within, I would say, four to 12 weeks, patients are back to their baseline and are back to the normal activities, in which case also patients who were referred to us from other centers and we see patients even who live three and four hours away can go back to their referring oncologists and continue their follow up with them. So as I mentioned, the CRS timing can be disease specific. With abecma, they really see most of the CRS within the first three days. And so the idea of monitoring through that window and being able to go home early, you know, is an active area of investigation. For the prescribing information, we're keeping everyone for 14 days. Similarly with the carvicti, we're planning 14-day hospital admission. There, the CRS tends to peak seven days in, so it's a slightly different timeline. But I think most programs are aiming towards outpatient infusions and monitoring. And as long as we're able to catch the toxicities in time and have the availability for an admission, I suspect that admission time will be getting shorter very soon. Will a patient need to stay near the treatment center once they are released? If so, for how long? Similar to a transplant, we like to keep patients in the hospital during the most acute time, the most likely toxicities, but these do extend beyond. And so at the moment, most of us have a two week post-infusion hospital stay. As soon as the patient is stable, not having fevers, doing well, able to go home, around day 14, most patients are eligible to then go home. And most centers require that they stay within an hour of the institution. Some places allow a slightly further. I think it depends and should be really managed case by case. Certain patients are at much higher risk of these toxicities than others, such as patients with a high tumor burden going into the CAR-T, patients who have high comorbidities, and other factors that we know place them at higher risk. Many of our patients by the day 15 when they come to their first outpatient appointment are eager to get back to work, are feeling themselves, have recovered their counts. Some patients do have prolonged cytopenias. They may require transfusion support up to twice a week. And so really a case by case basis. But on average, we plan for two weeks in the hospital and two months of close follow up. Will a patient need a full time caregiver? So given the risk of ICANNs and other neurotoxicities and the unpredictable nature, for one, because they are rare events, so we don't have as many cases to go on and have learned for, we generally ask patients not to drive, not to do anything that a neurologic condition would have an adverse effect. And that's the biggest driver in having a required caregiver for those first 60 days. Is there a diet patients will have to follow? Different patients will recover counts at different rates. Prolonged cytopenia is a rare but very much recognized toxicity. Some patients will recover counts but then lose them again and may have low counts for weeks to months following. The vast majority will have fully recovered counts. And so depending on their individual neutropenic status, they should stay on a low microbial diet or be liberated, sometimes much later than others.