Statistical considerations
toxicity
In this phase I clinical trial, sample sizes were not based on statistical methods. The aim of both trial parts was to evaluate the toxicity profile rather than formally to demonstrate any efficacy endpoints. The database cut-off date was April 30, 2021, when all participants had reached 24 months of follow-up, and OS data were updated last October 5, 2022.Descriptive statistics were used to categorize AEs according to their nature and severity. Furthermore, descriptive statistics were applied to demographic data, CTC results, and generation of the global HRQoL spider plot and line graphs, to demonstrate changes in TCR clonotype counts and longevity, and to depict percentage changes by waterfall plots.Unless otherwise stated, all statistical testing between groups was made by Fisher’s exact tests, two-sided Mann–Whitney U tests, or Kruskal–Wallis tests.Statistical significance was defined as PFS and OS were estimated at database cut-off with corresponding 95% confidence intervals estimated by the Kaplan–Meier method and independent groups compared by log-rank tests. Data analyses were performed either in R v.3.6.0 or higher [