CAR T-cells in Israel: Clinical development and outcomes of the Sheba institutional-initiated program

For hematologic malignancies, genetically modified autologous CAR T-cells have spearheaded the immunotherapy revolution, given initial clinical success and later regulatory approval of CD19 targeting agents. Since 2016, we developed a clinical-grade local production of CD19 CAR T-cells program, and initiated a phase Ib/II clinical trial targeting various hematologic malignancies, in both children and adults. With more than 100 patients treated to-date, locally produced CD19 CAR T-cells achieved high remission rates in previously relapsed and resistant patients in Israel, echoing worldwide clinical results. Here, we will share the pathway to clinical trial initiation, clinical outcomes, discuss the challenges and benefits of an institutional based program, and options for future development.