Immunotherapy using CAR T: What we have learned from trials and where we are heading

Chimeric antigen receptor (CAR) T-cell therapy is successful in the treatment of liquid cancers and is being investigated in solid tumors. While immunotherapy by way of immune checkpoint inhibitors is now standard of care therapy for some solid tumors, there are substantial differences in the design, conduct, and interpretation of immune checkpoint inhibitor clinical trials compared to CAR T-cell clinical trials. In this chapter, we describe the key comparisons between cell therapy and immune checkpoint inhibitor clinical trials and highlight the lessons learned from conducting CAR T-cell trials in a high-volume cancer center. Utilizing this learning experience, we provide guidelines for optimizing the clinical flow of CAR T-cell trials. We believe that a structured approach for CAR T-cell trials in solid tumors as described here can be adopted by other cell therapy trials and provide insights to advancing immunotherapy.