Larry Saltzman, MD: Participating in a Clinical Trial for CAR T-cell Therapy During a Global Pandemic

Since his diagnosis with chronic lymphocytic leukemia in January 2010, life for Larry Saltzman, a board-certified family physician, has been a roller coaster. In the past 11 years, he has gone through several therapies, three clinical trials, several recurrences, and some serious side effects from his treatments.

One of the challenges that he faces is being immunocompromised during the COVID-19 pandemic as a result of leukemia treatments that depleted his body of B cells that make antibodies. This makes him more vulnerable to infections including COVID-19 because he does not have the protection usually conferred by vaccination.

“I know through some blood testing that the COVID-19 vaccines have not produced any antibody response in my system,” Larry said. “When I was in chemotherapy, I was very careful about being in public. I learned how to not shake hands and how to elbow bump with people. And with the world we’re living in today, I’m even more secluded because I have no immunity. So, I’m very careful.”

As a result, Larry is an avid advocate of vaccination.

“I rely on people around me to get vaccinated and protect themselves,” he said. “Ultimately that protects me from this infection. And it is just very hard to stomach when I hear about people who are vaccine hesitant.”

In December of 2009, Larry felt some bumps on his neck that turned out to be swollen lymph nodes. Follow-up tests led to a diagnosis of leukemia. Upon his physician’s recommendation, Larry followed a “watch and wait” approach up until 2013, when he had a flare-up and began treatment with a chemotherapeutic.

Since then, he has been on several treatment regimens, including molecularly targeted therapeutics such as ibrutinib and, as of December 2019, an experimental immunotherapeutic, known as CAR T-cell therapy, through a clinical trial at the Fred Hutchinson Cancer Research Center in Seattle. The CAR T-cell therapy effectively controlled his cancer but also caused many serious side effects. He was hospitalized twice within a month of receiving the treatment with episodes of cytokine release syndrome.

“The CAR T cells create inflammation…and because it inflames everything, my heartbeats were not normal rhythm. It also affected my lungs and my brain,” Larry said.

Following his CAR T-cell treatment at the end of January 2020, Larry returned home to Sacramento. Soon after, the United States was hit by the first surge of the COVID-19 pandemic. Because he was immunocompromised, Larry’s health care team urged him to stay at home and avoid any potential exposure to SARS-CoV-2. This caused serious disruption to his participation in the clinical trial, which required regular follow-up care and visits to Seattle. When the country and most of the health care facilities shut down in March 2020, Larry couldn’t return to Seattle for the bone marrow biopsies, scans, and blood tests that were part of the clinical trial protocol.

“I was in Sacramento with CAR T-cell treatment that couldn’t be stopped. And when I asked my doctors in Seattle, they said: We don’t want you on an airplane. We don’t want you in Seattle. You’ll just have to do the best you can.”

The pandemic also took a toll on his social and personal life. Larry and his wife have been reluctant even to go into a grocery store or to travel to Seattle to see their son and his family.

“It’s been a real emotional challenge because we are social beings and we have not been able to be social,” he said.

Moreover, as a physician, Larry is concerned about the long impact of the pandemic on public health.

“I worry about how many people are missing their mammograms or their colonoscopies, or other preventative treatments or procedures that should be done to keep people healthy.”

Another area of patient care that has been adversely impacted by COVID-19 is clinical trials, which are key to the development of new and improved anticancer agents. Although the pandemic has caused a decline in enrollment in clinical trials because patients are worried about exposure to COVID-19, adult recruitment in cancer clinical trials was an ongoing challenge even before the pandemic. There are many barriers, including out-of-pocket costs related to treatments or travel, that deter patients with cancer from enrolling into lifesaving clinical research. This is a real issue that needs to be addressed urgently.

“I think if policy makers could take a closer look at what it takes to manage the preparation and testing of new treatments and what the real cost is, we would all be much better off,” Larry said.