Topic Significance/Background This is an unparalleled time in cancer research, particularly with the use of cellular therapeutics to target both solid and liquid tumors. This science is challenging the boundaries of clinical care to update guidelines, streamline processes, and integrate clinical and research teams. The University of Kansas Cancer Center was launched into the cell therapy space when we enrolled the first adult patient on Novartis Juliet CAR-T trial for DLBCL. Our team learned that inpatient and outpatient infrastructure and multidisciplinary collaboration are essential to promoting quality clinical care to complement this innovative new field of cellular immunotherapy. As of September 2019, our center has 19 active cell therapy trials, 10 studies in start-up, and 27 in the research pipeline. We have had the opportunity to participate in clinical trials assessing safety and efficacy of TILs, CAR-T and TCR in the cell therapy space, along with expanded umbilical, placental, and mesenchymal stem cell products. In order to optimally contribute in this dynamic and vastly changing landscape, it was essential for our teams, both research and clinical, to come together and develop a forum in which all new cell therapies are discussed and vetted. Intervention In order to facilitate this multi-disciplinary cell therapy forum, we instituted the Immune Effector Cell (IEC) Committee. The IEC committee started as a pre-start-up review panel that focused on feasibility of trial conductivity and ensuring appropriate resources and processes were in place for each trial. The IEC committee has now evolved into a formal Disease Working Group (DWG) responsible for the review of all open trials in the cell therapy space, deviation review and reporting, enrollment and accrual management, and patient safety in addition to feasibility and care algorithm management. The IEC DWG meets monthly. Members include clinicians, dedicated cell therapy research staff, pharmacists, laboratory personnel and cancer center leadership. Discussion/Implications The new era of cellular immunotherapy is challenging current clinical trial oversight and workflow development to ensure novel therapies are transitioned seamlessly into clinical care. Developing a structured, multidisciplinary IEC DWG with supervision over all cell therapy clinical research serves as a foundation for innovative, quality care. This forum's assessment of upfront workload promotes synergy with all teams supporting cell therapy including research, apheresis, cell processing, inpatient and outpatient clinical programs. The IEC DWG infrastructure is a supportive environment for solid tumor cell therapy to integrate into the existing clinical framework. Future work at our institution includes a standard site readiness tool to facilitate communication and integration.
Read full abstract