Statistical analysis
No formal hypothesis was tested in the phase I study. Design considerations were not made with regard to explicit power and type I error considerations, but were made to obtain preliminary safety, feasibility, pharmacokinetics, pharmacodynamics and antitumour activity information in this population. Dose escalation was conducted in a traditional 3 + 3 design, and each dose level was cleared with 3 patients treated with 3 TCRs. Measurements were taken from distinct samples. neoTCR editing and IFNγ production at product release are reported as the average of two replicate tests from the same sample. For correlations, data were first tested for normal or log-normal distributions. Pearson’s correlations were performed on normally distributed data, otherwise Spearman’s correlation was performed. Additional statistical tests are indicated in each figure legend.