May 27, 2021
The Important Role of Nurses in Cell Therapy
Erica Elefant is Director Clinical Scientist at Adaptimmune. Managing all aspects of our clinical trials from beginning to end, she is a member of the team working on the Phase 2 SPEARHEAD-1 trial with our cell therapy afamitresgene autoleucel. The Company recently reported initial data from the trial showing an overall response rate of 39.3% (13 out of 33 patients), 41.4% (12/29) for synovial sarcoma and 25.0% (1/4) for MRCLS. Based on this data, we intend to file our first BLA next year.
Having trained as a nurse, she tells us about her journey and her motivation to bring more focus on nurses in the field of cell therapy.
What did you do before you started at Adaptimmune?
After an initial career as a social worker, I chose to move into the field of nursing. I was employed full time while going to nursing school – and one of my professors introduced me to a physician in need of a trial coordinator. I had no idea what the job entailed except logistically I could work where I was going to school – so I took a leap of faith and moved into this role for 3 years until I graduated. I took a job at Children's Hospital of Philadelphia’s clinical research institute managing pediatric trials. From there, I held Clinical Science Operations roles at BMS, Janssen and Avid, before making my way to Adaptimmune two years ago.
What is the role of nurses in cell therapy?
Nurses play a critical role throughout the patient journey when receiving cell therapy in a clinical trial. They are the ones who spend the most time with patients. They start the patient interaction from the very beginning and provide patients with information on all aspects of the trial, including eligibility criteria, schedule of steps such as apheresis, how the T-cells work and are administered, as well as the type and frequency of tests/evaluations that will be performed. There is a good deal of information that is presented that can take time for a patient or caregiver to absorb. Nurses can ensure their questions and concerns are addressed.
In addition to the education and support, nurses are also typically in charge of scheduling the trial procedures required for gathering data. Finally, nurses are the ones administering the lymphodepleting chemotherapy and T-cell therapy, meaning that they are on the front line for assessing and managing adverse events (AEs).
What motivated you to present the poster at ONS?
One of my favorite parts of the job is conducting training for the research staff at the sites conducting our trials – especially nurses who play a significant role in working with patients in our trials.
To effectively care for patients receiving SPEAR T-cell and other cell therapies, nurses need to be equipped with knowledge about these novel therapies. I saw a need to start engaging with nurses to provide information to enhance their practice.
I was pleased to collaborate with nurses on our trials to develop the poster presented at the 2020 Oncology Nursing Society meeting titled ‘Nursing considerations for the use of MAGE-A4-targeted SPEAR T-cells in patients with synovial sarcoma’. Presenting a poster is a great opportunity to disseminate information to a broad group of oncology nurses.
What has been the nurse’s response to the ONS poster?
They have welcomed it as something that will provide them the knowledge they need, and agree it is crucial to share this information with more nurses. The cell therapy landscape is constantly evolving and comprised of many aspects – so it is imperative nurses are kept up to date on these new therapies for them to be prepared on how to best care for patients who may be treated.
In terms of nursing considerations, what has been your experience working in cell therapy clinical trials?
I have learned that the centers conducting cell therapy trials require a complex infrastructure to manage the patient journey from patient identification, through apheresis and lymphodepletion, to the safe infusion of the T-cell therapy. Nurses have a key role in navigating the patient through the treatment process.
This includes the monitoring and management of unique AEs such as cytokine release syndrome, cytopenias and neurotoxicity requiring safety assessments after the patient receives the T-cells. Nurses also perform long-term monitoring done in an out-patient setting and educate patients and families on the identification of these AEs once released from the hospital.
Is there anything else that needs to be done to increase the level of support available to nurses?
When treating patients with cell therapies in our trials, we request tumor tissue samples, often requiring biopsies, which is an invasive procedure, to conduct translational science analysis to further our understanding of these therapies. We started work on materials nurses can use to explain to patients why these samples are so important and how agreeing to a biopsy can contribute to research which can ultimately help them and future patients.
I also believe that we need to create and provide more forums for nurses to access clinical trial data as this can prepare nurses to provide evidence-based education on associated risks/benefits. Overall nurses’ clinical practice can be enhanced when equipped with information and knowledge associated with the administration of these novel therapies.