Mapping real-world car T-cell implementation to support future scale out - DR

The National Cancer Institute awarded ST Jude Children's Research Hospital Inc. $283,091 on September 2, 2026, under the Cancer Research Manpower program (CFDA 93.398) to support a career development project in implementation science for pediatric CAR-T cell therapy.

The award funds Dr. Duffy's research to identify generalizable lessons for implementing chimeric antigen receptor T-cell programs across resource-constrained healthcare settings and to develop tools facilitating CAR-T program scale-out. Using the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework, Aim 1 engages five pediatric oncology centers—two in Brazil, one in India, one in Singapore, and one in Vietnam—that have recently established CAR-T programs to identify multilevel determinants, stakeholder networks, and implementation strategies associated with successful program development across varied regulatory, financing, manufacturing, and healthcare delivery environments. Aim 2 uses these findings to develop and validate an implementation planning toolkit for future CAR-T program expansion. Research activities include stakeholder interviews and focus groups, collection of program-level implementation data, and social network analysis to identify infrastructure, workforce, partnerships, and implementation strategies required to deliver CAR-T across heterogeneous settings.

The project runs through August 31, 2031, with place of performance in Memphis, Tennessee.

Duffy's career goal is to be an independent investigator in clinical and implementation science research with the skills to improve access and effectively translate novel, evidence-based therapies for children with cancer globally. Chimeric antigen receptor (car) T cells were FDA-approved for pediatric all in 2017, yet substantial multilevel barriers limit access to car-T in resource-constrained settings. This award will provide DR. Duffy with the training and research experience to identify generalizable lessons for implementation strategies and develop tools to facilitate car-T program development across a variety of healthcare environments. Using the exploration, preparation, implementation, and sustainment (EPIS) framework, aim 1 will engage five pediatric oncology centers administering car-T therapy to identify multilevel determinants, stakeholder networks, and implementation strategies associated with successful program development. Each of these five centers (two in brazil, one in india, one in singapore, and one in vietnam) has recently established unique approaches to car-T program development and provides expertise in program implementation across a variety of regulatory, financing, manufacturing, and healthcare delivery environments. Aim 2 will use these findings to develop and validate an implementation planning toolkit to facilitate future car-T program scale-out. Research activities will include stakeholder interviews and focus groups, collection of program-level implementation data, and social network analysis to identify the infrastructure, workforce, partnerships, and implementation strategies required to deliver car-T across heterogeneous settings. Engagement with these successful "early adopter" centers is necessary to identify novel strategies, infrastructure models, and manufacturing approaches that do not currently exist in the united states (U.S.) and may inform more efficient, scalable, and accessible car-T delivery domestically. This research directly supports the mission of the NIH and NCI by generating evidence to accelerate the adoption of less toxic, more effective cancer immunotherapies and to ensure real-world implementation keeps pace with scientific discovery. Furthermore, IT will also provide implementation strategies to expand car-T access in underserved and resource-constrained U.S. Healthcare settings, improving survival and reducing the burden of the most common pediatric cancer. The results from this K08 will inform the development of a future R01 to evaluate the impact of this car-T implementation toolkit on car-T program development. Through the proposed activities, DR. Duffy will acquire training in 1) methodologies to facilitate translation of complex interventions (social network analysis, qualitative analysis, delphi methodology); 2) global policy; 3) clinical immunology; 4) and leadership and career development at the intersection of pediatric global oncology and implementation science. These skills will generate rigorous, multilevel evidence and strategies to support the real-world translation of car T-cells and foster DR. Duffy's transition to independence.