Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Clinical Trial of Cell-based Immunotherapy Products (Interim)” (No. 14, 2021)

In 2017, the former State Food and Drug Administration issued the "Technical Guidelines for Research and Evaluation of Cell Therapy Products (Trial)", which generally elaborated on the technical requirements for the development of cell therapy products in accordance with relevant drug management regulations. Since the release of the guidelines, the number of research and development and registration applications for cell therapy products in my country has increased significantly, especially immune cell therapy products.

Immune cell therapy is a treatment method that uses the patient's own or donor-derived immune cells, which are cultured, expanded, activated, or genetically modified, edited, and then returned to the patient's body to stimulate or enhance the body's immune function, thereby achieving disease control, including adoptive cellular therapy (ACT), therapeutic vaccines, etc. According to different mechanisms of action, the current types of cell immunotherapy research mainly include: tumor-infiltrating lymphocytes (TILs), chimeric antigen receptor modified T cells (CAR-T) and engineered T cell receptor modified T cells (TCR-T). In addition, there are other immune cell treatments based on natural killer cells (NK) or dendritic cells (DC), such as cytokine-induced killer cells (CIK).

When immune cell therapy products enter clinical trials, they should follow the general principles and requirements of the Good Clinical Practice (GCP) and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6. At the same time, the cell source, type, in vitro operation and other aspects of immune cell therapy products are highly heterogeneous, and the treatment principles and in vivo effects are more complicated than traditional drugs. In order to achieve the expected therapeutic effect, immune cell therapy products may need to be administered through specific operational measures, administration methods or combined treatment strategies. Rigorous and scientific clinical trials are essential to ensure the safety of subjects and generate reliable clinical trial data. In view of the special biological characteristics of immune cell therapy products, an overall clinical trial strategy different from that of other drugs needs to be adopted in clinical trial research. Therefore, within the framework of the above-mentioned guidelines, it is necessary to further refine the technical recommendations for conducting clinical trials of immune cell therapy products in order to provide more targeted recommendations and guidelines for drug development registration applicants (hereinafter referred to as applicants) and researchers conducting drug clinical trials (hereinafter referred to as researchers).

Specific news link: Notice of the Center for Drug Evaluation of the National Medical Products Administration on the release of the "Technical Guidelines for Clinical Trials of Immune Cell Therapy Products (Trial)" (No. 14 of 2021)