Exploration of risk control in phase I clinical trials of T cell therapy against cancer

FANG Ying-ying; WANG Xing-he

doi:10.20251/j.cnki.1003-3734.2025.12.007

Abstract：With the increasing difficulty in the treatment of relapsed and refractory malignant tumors,the research on phase I clinical trials of T cell therapy for tumors is becoming more and more in-depth.We discussed the risk control strategy of early clinical trials of T cell anti-tumor therapy by taking into account the current regulations and the latest guidelines at home and abroad,and the special characteristics of early clinical trials of T cell anti-tumor therapy.In terms of drug specificity,it was emphasized that T cell therapy had a unique metabolic process with high risk.In terms of the specificity of early anti-tumor clinical trials,the characteristics and requirements of T cell donors and enrolled patients were emphasized.For risk control,in terms of design,it was emphasized that safety come from design,and it was clarified that the therapeutic efficacy of T cell therapeutics was related to their implantation or transduction efficiency,and that attention need to be paid to the influence of inactive particles and other substances on their therapeutic efficacy and dose,and it was suggested that dose backfill,machine modeling and simulation,and intermediate-term analysis could be used to achieve dose optimization.In terms of management,it was emphasized that safety stems from management,and it was recommended that the management of serious adverse events could be strengthened.Strengthening management in terms of investigator manuals,drug management,and emergency response process for adverse events was emphasized.In terms of implementation,combined with the complexity of the preparation and transportation of cell therapy drugs,feasible suggestions were made.