CMC evaluation considerations for tumor-infiltrating lymphocyte in clinical trial application
CUI Jing
WANG Xue
WEI Wei
Abstract：In recent years,tumor-infiltrating lymphocytes(TIL)as a type of cell therapy product in adoptive T cell therapy(ACT)have attracted widespread attention,and clinical studies have been conducted in various solid tumors.Compared with other cell therapies such as chimeric antigen receptor T-cell immunotherapy(CAR-T)and T-cell receptor engineered T cells(TCR-T),TIL possess advantages such as better tumor tropism,the ability to targeting and recognize multiple tumor antigens,and lower immunotoxicity.Currently,one TIL product has been approved for marketing and the number of TIL products approved for clinical trials is increasing rapidly,multiple TIL products in China have also obtained approval for clinical trials.Based on current knowledge and combined with evaluation experience,this article summarizes the safety-related issues in the chemistry,manufacturing,and controls(CMC)of TIL during the clinical trial application and proposes evaluation considerations,aiming to promote the development and clinical application of TIL products.
Keywords：tumor-infiltrating lymphocyteschimeric antigen receptor T-cell immunotherapyT-cell receptor engineered T cellsclinical trialschemistrymanufacturingand controls evaluation
Publication Date：2025-12-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 2622-2628 )