Considerations for patient selection for cell and gene therapy trials using tumor associated antigens as target in early phase development

For cell and gene therapies, including those using tumor associated antigens (TAAs) as targets, effective patient selection is critical for success. In this paper, we discuss considerations for patient selection for cell and gene therapy products in early phase clinical development. Surprisingly, many obvious key factors like the TAA themselves, the major histocompatibility complex (MHC), as well as practical implication of patient selection on the trial design and conduct are not given the consideration that they should be given. The article focuses on ideal patient selection for cell and gene therapies using TAAs and implications for clinical trial design.

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