January 2018 Edition Vol.11, Issue 1

CAR and Driver: Prepping Moffitt Cancer Center to Deliver CAR-Ts

By Neil Canavan

Choosing Frederick Locke, MD, to head up the formation of the cancer immunotherapy wing at Moffitt was a gimme. “Throughout my career, even before I went to medical school I’ve wanted to utilize the immune system as a way to treat cancer,” says Locke.

In February 2015, Locke convened a meeting of Moffitt’s bone marrow transplant, and malignant hematology faculty to discuss how to bring CAR-T cell therapy to their patients – because Locke already knew that, it was not a matter of if the technology would be commercialized, but when.

“It became clear that (CD-19 directed) CAR-T cell therapy was really on the cusp of a breakthrough,” Locke recalls. Single center investigations were reporting astounding efficacy in hematologic cancers, and in particular, pediatric ALL, and registration trials for FDA approval were rapidly accruing. “It was pretty clear that these had the chance to be revolutionary in the treatment of these diseases, so at that point we sought to get involved,” adding that Moffitt had to move quickly, having not been involved – unlike the University of Pennsylvania – in any of the developmental efforts of CAR-Ts.

Thus, the rapid formation at the Moffitt Cancer Center of the Immune Cell Therapy service (ICE- T).

Which is not to say that the effort was without certain challenges, such as turf wars. “There was a potential for that, for those divisions,” Locke admits. “We had to break down silos and barriers so the leukemia doctors and the lymphoma doctors could work together in a way that serves all doctors across the institution.”

The experience was not entirely de novo, after all, the first immunotherapy, the checkpoint inhibitor, Yervoy, was approved for solid tumors in 2011. “That’s part of how the ICE-T service came about,” explains Locke, “Because we needed a place to put these patients that were getting these therapies that resembled each other (immunotherapy), but in patients that all had different diseases (leukemia, lymphoma, lung cancer). So instead of sending one patient to the leukemia service to get CAR-T, and another to the lymphoma service to get CAR-T cell we pulled it all together with a new clinical service.”

Great. Now down to brass tacks: what did Locke/Moffitt actually do? “We created a new group to monitor the (treatment) for these patients, so a team of expert clinical trial coordinators, and data managers who were familiar with these cellular immunotherapies, as well as administrators, and infrastructure.” To wit:

  • Five new faculty to handle the increased volume (estimated at 175 patients per year)
  • Two new hires, one PhD., one MD, PhD, to develop new CAR-T constructs
  • A new, larger, apheresis unit for collecting patient’s T cells
  • Six additional beds in the outpatient facility, for a total of 19
  • A new inpatient/outpatient wing for cellular therapy (planned)
  • Financial specialists

“We have a whole team at Moffitt focused on reimbursement for this.” Assuring that they have authorizations, figuring out strategies to deal with Medicare/Medicaid… “We’ve been preparing for many months, and the executives at Moffitt, and our chief financial officer has really led a lot of the team that’s focused on operationalizing this, making sure it’s viable.”

Any advice for institutions looking at the potential of the CAR-T market?

“You need to leverage your existing hematopoietic stem cell transplant program, (and have people) come together to create the expertise required,” says Locke, who sees little choice if you want to stay in the game, because after all – “I believe this therapy is here to stay.”

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