Major challenges:
“(1) As the development of autologous CAR-T therapy may be subject to manufacturing failure, should the randomization occur before or after the ‘successful’ product being developed?
(2) Eligible subjects may receive bridging therapy prior to the administration of CAR-T product during the manufacturing period. How should the treatment effect of interest be properly addressed given the joint effect of bridging therapy and CAR-T product? [I would expand this line of questions to include radiation therapy in the context of solid tumor CAR pre-conditioning regimens and the (putative) synergistic effects between (investigational) adoptive cell therapies and radiation therapy]"
Source: https://ww2.amstat.org/meetings/biop/2020/onlineprogram/Program.cfm