General Considerations for Early-phase Clinical Trials of Chimeric Antigen Receptor T Cell Therapy

Abstract

Abstract: Objective To discuss the factors that affect the design of early-phase clinical trials and analyze the designing principles and methods of early-phase clinical trials. Methods The influencing factors of the clinical trials of CAR-T cells including the product characteristics, preclinical study and safety risk were analyzed, and the important considerations for the early clinical trials were summarized in terms of study objectives, subject and trial design, etc. Results The product characteristics, pre-clinical studies and safety risks of CAR-T cells are significantly different from other drugs, all of which have significant influences on early clinical trials. Conclusion It is important to explore the effective dose, side effects, and initial effectiveness of CAR-T cells in early clinical trials, and furthermore, the clinical applicability and process stability of CAR-T cells should also be validated in early clinical trials.

Key words: chimeric antigen receptor T cells, early-phase clinical trial, pre-clinical study, safety, trial design

CLC Number:

R969

GAO Jian-chao，GAO Chen-yan . General Considerations for Early-phase Clinical Trials of Chimeric Antigen Receptor T Cell Therapy[J]. Chinese Journal of Pharmacovigilance, 2017, 14(10): 611-614.

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