Development of Chimeric Antigen Receptor (CAR) T Processes

Abstract

Topic Significance & Study Purpose/Background/Rationale Chimeric antigen receptor therapy (CAR-T) is an autologous genetically engineered cell that can lead to dramatic responses in patients with refractory or relapsed leukemia and lymphoma. As a result, two new commercial products, Yescarta and Kymriah, were approved by the Food and Drug Administration (FDA) in October 2017 and May 2018, respectively. CAR-T cell therapy is also associated with a high risk of toxicities prompting many institutions to provide care to these patients on the blood and marrow transplant (BMT) unit. Incorporating this new therapy into existing BMT units presents both challenges and opportunities. The impact has created a dynamic process of change. The purpose of this abstract to describe our experience in developing the infrastructure for the safe administration of CAR-T therapies into an established BMT program. Carefully developing a comprehensive and dynamic approach to CAR-T cell therapies will serve as a foundation for other immune effector cell therapies that will arise in the future. Methods, Intervention, & Analysis To develop the infrastructure, consideration must be given to workflow, policy development, staff and patient education and developing quality metrics to monitor and improve patient care. We developed nursing policies and standards of care. Standards of care specify required assessments and interventions. A key component of the education included standardizing the grading of toxicities so that communication between team members is consistent. All members of the multidisciplinary team needed to complete Risk Evaluation and Mitigation System (REMS) education. New templates for the documentation were developed. We developed metrics for the quality management plan that included expected outcomes. Thresholds for metrics were developed to ensure that if standards are not met there is a plan to investigate. Collaboration with specialists, such as neurology and emergency room staff to inform our management of toxicities. Findings & Interpretation Incorporating a high-risk treatment on an established BMT unit, a thoughtful and comprehensive review of current practices must be performed to develop the infrastructure to ensure the safe and effective administration of the new therapy. Discussion & Implications To optimize the success of CAR -T therapy outcomes, collaboration, education and a comprehensive review of the programs infrastructure must be evaluated and revised.