Investigational Cell Therapy Beyond Oncology: Education, Communication, and Lessons Learned from Utilizing a Centralized Oncology Based Cell Therapy Program

Abstract: Scientific challenges of cell therapies are frequently published and discussed, but the operational challenges of supporting cellular therapy trials in non-oncology programs are not well documented. We reviewed study operational hurdles and methodologies to optimize communication and education for non-oncology caregivers and PIs participating in cellular therapy research. Additionally, we developed methods to promote research compliance and ensure patient safety when treating non-oncology patients with novel cell therapies by developing a centralized cell therapy team based in an oncology research program.

Introduction: To support the unique requirements of cell therapy research, the Swedish Cancer Institute hematology cell therapy team acted as the centralized support program to guide patients and non-oncology disease teams through the highest acuity part of the protocol from preparing for cell collection to clinical management until day +30 post cell infusion. Non oncology indications for investigational cellular therapy included Systemic Lupus Erythematosus, Multiple Sclerosis and Systemic Scleroderma studies with both allogenic and autologous cell products. Multiple methods of communication, education, and management were used to support these non-oncology research teams and patients. The best practices we developed are discussed here.

Methods: Improvement methodologies primarily focused on review and improvement of communication and education focused on physicians, research team members and patients. Communication improvements at the physician level included multidisciplinary workgroups being formed for trial review with the cell therapy medical director in which all cell therapy trials would be vetted by the cell therapy team for scientific merit and feasibility. Local steering committees would independently verify the utility of studies for the disease indication. Study sponsors were communicated with to ensure that a second screening visit with a physician was included in study budgets to ensure that a cell therapy physician would meet with patients prior to consenting to ensure patient's awareness of cell therapy involvement and to have patients make fully informed consent decisions on participation. Research operations held multiple meetings to develop patient flow methodologies that enabled disease team experts to manage disease nuances while the cell therapy team managed cell therapy components. Multidisciplinary pharmacy and budget review was implemented to ensure medications that would traditionally be covered as part of oncology care were reviewed for non-oncology patients. Ensuring the regulatory teams understood the necessary staff across both teams and managed both IRB and IBC site listings was essential, and a multidisciplinary approach was needed. Modifying materials related to cell therapy to become inclusive of non-oncology patients was one of the focus areas of improving patient education.

Results/Conclusion: Developing a central cell therapy team structure and frequent communication to specify who manages specific portions of both the study and the patient journey proved to be a critical component of our multidisciplinary approach. Constructing preferred communication pathways and patient flow prior to subject enrollment was important to establish continuity of patient care. Developing an ongoing continual process improvement review and feedback mechanisms for all members of the multidisciplinary groups was critical to patient safety and study compliance. Creating reoccurring meetings with stakeholders has allowed continual review and improvements to the centralized cell therapy support model at Swedish Cancer Institute. Developing a structured framework that non-oncologic trials could be integrated into with the flexibility for unique patient care scenarios has enabled the cell therapy team to remain adaptive for current and future cell therapy trials. At Swedish non-oncology teams have been able to onboard new trials and successfully treat multiple patients using the described centralized cell therapy model.

Namburi:Pfizer: Honoraria; GSK: Honoraria; BMS: Honoraria; Genentech: Honoraria; Janssen: Honoraria. Patel:AstraZeneca: Consultancy, Research Funding, Speakers Bureau; Kite: Consultancy, Research Funding, Speakers Bureau; BeiGene: Consultancy; Epizyme: Consultancy, Research Funding; Curis, Inc: Research Funding; CRISPR Therapeutics: Research Funding; Pharmacyclics/Janssen: Consultancy, Research Funding; Nurix: Research Funding; Morphosys: Consultancy; Merck: Consultancy, Research Funding; MEI Pharma: Consultancy, Research Funding; Loxo Oncology: Consultancy, Research Funding; Genentech/Roche: Consultancy, Research Funding; Fate Therapeutics: Research Funding; Caribou Biosciences: Consultancy; Bristol Myers Squibb: Consultancy, Research Funding, Speakers Bureau; Adaptive Biotechnologies: Research Funding; ADC Therapeutics: Consultancy; AbbVie: Consultancy; Sunesis Pharmaceuticals: Consultancy, Research Funding; TG Therapeutics: Consultancy, Speakers Bureau; Trillium Therapeutics/Pfizer: Consultancy, Research Funding; Xencor: Consultancy, Research Funding.