Jeff Sharman, MD, discusses monitoring for CAR T toxicities in R/R NHL in the community setting, the importance of patient and caregiver education to identify adverse events, and long-term safety monitoring.

Transcript

Jeff Sharman, MD: Our protocol for monitoring these patients will include daily visits to the clinic, and some of those will be just with the treating nurse. But there is also the expectation that not 1 but several of the members of the team will have the opportunity to see the patient during their daily visits in the immediate post-treatment phase. Once a patient is out some length of time, the frequency and intensity of those will decrease, so it might be several times per week. Patients are also educated about what to do in the event of an adverse effect, and they have to have a caregiver who’s also trained who can spot those adverse effects if the patient is not able to do so. Given neurotoxicity, patients may not always be aware of their own, what’s going on inside them, particularly adverse effects such as confusion. There’s really a close follow-up for these patients that lasts for a full month. What we’ve seen in doing this in the outpatient setting is that a sizable fraction of patients can get through without requiring hospitalization.

In the long term, that monitoring continues. It’s not only the short term but also the long term, and these patients are at risk for development of hypogammaglobulinemia or low antibody levels. Oftentimes these patients may need replacement intravenous immunoglobulin, IVIG. But also, because this is a gene therapy product, there’s requisite long-term monitoring to ensure either no secondary malignancies or events triggered by the therapy itself. These patients are followed for a longer period of time.

Patients who have a complication postprocedure are going to be evaluated and triaged according to the nature of their adverse effect. But many of these patients are going to end up hospitalized for management until we know that the adverse event has subsided. With particular attention to neurotoxicity as well as the possibility for cytokine release syndrome, even a subtle fever—which might otherwise be discharged from the emergency department outside a CAR T context—that patient is going to be admitted for monitoring and observation with care appropriately escalated and de-escalated as needed. Ultimately that patient will hopefully be able to go home. That would be the expectation. It’s a really low threshold for a patient experiencing an adverse event to be hospitalized for the monitoring.