A number of non-stem cell therapies, including cellular vaccines and chimeric antigen receptor (CAR) T cells, are offered to cancer centers. “Demand is growing, with several CAR products heading for imminent U.S. Food and Drug Administration approval,” said Sarah Nikiforow, MD, PhD, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School in Boston, MA.
“The variety of products poses a challenge to even experienced cancer centers,” she said. Nikiforow presented her work on behalf of colleagues on Monday, December 6, at the 58th American Society of Hematology Annual Meeting and Exposition in San Diego, CA.
Study authors sought to establish a clinical and operational infrastructure to guide the delivery of such treatments efficiently and safely. To do so, they used care models and workflows across different inpatient and outpatient settings, as well as disease group providers who weren’t yet familiar with cell therapies. In all, they conducted 30 interviews with internal stakeholders across different sites, including research, cell processing, nursing, physician, pharmacy, and operational areas and queried experts at other cell-engineering sites.
Interviews identified main areas of interest: cell distribution; trial initiation; communication, training, and clinical care; resource utilization; and safety and outcome monitoring. Researchers also established a steering committee to generate guiding principles: “make safety paramount, systematically coordinate care, recognize each cell therapy and sponsor’s unique requirements, and minimize unnecessary infrastructure.” The spectrum of care was also established, focusing on how patients are identified; financial clearance for treatment, admission, and administration; outpatient workup; cell collection; and post-infusion follow-up.
Several findings and subsequent strategies to address findings emerged.
- Cell distribution: Even though product manufacturing occurred at central contracted sites, novel internal workflows were required to ensure chain of identity through multiple hand-offs. A standard questionnaire, as well as biweekly meetings, were established so that staff could discussion logistics and impediments.
- Trial initiation: A start-up kit was established to communicated entities and workflows to guide investigators unfamiliar with cell therapies navigate submission.
- Communication, training, and clinical care: Guidance in budget design, tools to flag high-risk patients in electronic medical records (EMRs), and education on nomenclature were developed. Other strategies were implemented, including educational sessions; methods of communication for key issues through email lists, EMR flags, case management system, and toxicity management order sets; and a weekly forum for physicians and clinical stakeholders to share clinical events and needs.
- Resource use: Deficits were identified, dedicated clinician positions were formed, and scheduling was combined to enhance capacity within and outside current BMT infrastructure; and
- Safety and outcome monitoring: A format and forum was established for quarterly assessment of key outcomes allowing institutional oversight over the gamut of investigational cell therapies and standard of care administrations.
“With the explosion in outpatient cancer vaccines and CAR T cells, the need for additional physical resources, new medications, experienced clinicians, and communication tools became evident,” Nikiforow said. “The investment of individual centers to bring cellular therapies safely into clinical care should not be underappreciated, particularly given the high-risk nature of these treatments and the unique processes and high-coordinated activities these new modalities require.”