1. Nalley, Catlin

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With the growing momentum and success surrounding CAR T-cell therapy, the Cleveland Clinic Cancer Center recognized the importance of ongoing discovery in the field of cellular therapy. This prompted the development of a multidisciplinary team research approach.

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One of the individuals leading this charge is Betty Hamilton, MD, Associate Director of the Blood and Marrow Transplant Program at Cleveland Clinic, who is coordinating novel cellular therapies within different cancer programs to initiate and expand new clinical trials.


"Transplant is the original cellular therapy, and we have a lot of experience in this area, particularly now with CAR T-cell trials in lymphoma," noted Hamilton. "We already work closely with our lymphoma program and so it was a natural collaboration.


"It also made sense for all of these cellular therapies to come under one umbrella," she continued. "We recognized the need for a team-based approach to conduct these trials successfully, as well as to expand into other spaces, including solid tumors."


Collaborative Environment

The Cellular Therapy Assist Team, which is housed within the Blood and Marrow Transplant program, provides support to other disease groups, including myeloma, leukemia, thoracic oncology, and melanoma, and helps them optimize the management of cell therapy clinical trials.


The team is comprised of physicians, research coordinators, nurses, and program managers who work together to manage the logistics and operations of cellular therapy clinical trials. Team members review studies and opportunities for new research while working with various disease groups, explained Hamilton.


"When we become aware of a new protocol, the Cellular Therapy Assist Team, as well as the disease group, work together to open the trial and address any challenges," she elaborated. "These trials require significant coordination and collaboration between both groups because, while there are obviously disease-related issues, there are other issues to contend with as well.


"For instance, a lot of these trials involve lymphodepleting chemotherapy," Hamilton continued. "While the transplant team is very familiar with this, some disease groups may not have as much experience in this area. By working as a team, we are able to utilize everyone's specific expertise."


As cellular therapies continued to expand rapidly, Cleveland Clinic realized there was a need for a mechanism to assist the various disease groups, according to Hamilton.


"Our goal was not to take over the trial, but rather provide support," she explained. "We saw a gap where a dedicated team could help other research groups open cellular therapy studies while also assisting with administration of therapy and patient monitoring.


"We have developed a successful model for a team-based research experience in cellular therapy across different disease groups," she continued. "We recognize that there is a learning curve when it comes to not only conducting these trials, but also working collaboratively. And so, we continue to evaluate the resources needed and adjust our approach."


Since the Cellular Therapy Assist Team began, Hamilton has received a positive response from everyone involved. "From my perspective, it has been very helpful," she noted. "Due to the number of moving parts, cellular therapy research takes a village and I believe the other disease groups have also found it very valuable."


Successful cellular therapy trials depend on teamwork, Hamilton emphasized. "The logistics involved in this type of research are very complex and involve a number of different teams. Another critical layer of this work is, of course, the clinical care of patients, specifically the management of side effects of these novel therapies."


Ongoing research has shown that severe side effects can be associated with CAR T-cell therapy, such as cytokine release syndrome and neurotoxicity. Cleveland Clinic researchers are also exploring this area to better understand and address these adverse events.


"It really takes all of us to make sure we're taking the best care of patients and doing things as effectively and efficiently as possible," emphasized Hamilton.


Ongoing Expansion

Looking to the future, Hamilton envisions the continued growth of the CAT program and ongoing collaboration across Cleveland Clinic.


"We will see continued expansion through further collaboration," she said. "I believe this will become an enterprise-wide effort encompassing not only cellular therapies and immuno-oncology, but also immunotherapies in general, across a number of diseases. By not limiting ourselves, the program and its impact can continue to grow."


The outlook for cellular therapies is equally bright and Hamilton believes this approach will become the standard of care. "We continue to move towards more personalized, precise care that is tailored to a patient's specific cancer," she concluded. "This is truly an exciting time for oncology and cellular therapies, and critical to our success is team science."


Catlin Nalley is a contributing writer.


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