Bench-to-Bedside Perspectives on the Development of Soluble TCR-Based Protein Biologics: Current Landscape, Control Strategy and Future Direction
- 1School of Life Science and Bio-pharmaceutics, Shenyang Pharmaceutical University, Shenyang 110016, China
- 2State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, National Institutes for Drug Control, Beijing 102629, China
Abstract
Soluble T-cell receptor (TCR)-based biologics (protein-based) are an emerging class of immunotherapeutic agents that recognize antigenic peptides presented by the human leukocyte antigen (HLA) on the surface of target cells. Furthermore, they simultaneously bind to cluster of differentiation 3 (CD3) subunits on T cells, recruit T cells to target cells, and promote T-cell activation and degranulation, ultimately eliminating tumor cells. Soluble TCR-based protein biologics target intracellular antigens that are inaccessible to conventional antibody-based drugs. Consequently, the development of soluble TCR-based protein biologics has generated significant interest. One soluble TCR-based protein biologic is already approved for marketing, and several other drugs are entering clinical stages. Soluble TCR-based protein biologics have substantial therapeutic benefits but may cause cytokine release syndrome (CRS), off-target toxicity, and drug resistance. This review outlines the structural characteristics and mechanisms of action of soluble TCR-based protein biologics, introduces nonclinical research concerning soluble TCR-based protein biologics, describes the clinical progress, discusses the quality control of TCR drugs, and explores the challenges and possible future improvements for soluble TCR-based protein biologics.
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BibTeX
@article{zhang2026benchtobedside,
title = {{Bench-to-Bedside Perspectives on the Development of Soluble TCR-Based Protein Biologics: Current Landscape, Control Strategy and Future Direction}},
author = {Jingyi Zhang and Hongxin An and Chuanfei Yu and Weiyu Li and Meng Li and Lan Wang},
journal = {International Journal of Molecular Sciences},
year = {2026},
month = oct,
doi = {10.3390/ijms27198859},
url = {https://www.mdpi.com/1422-0067/27/19/8859},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Bench-to-Bedside Perspectives on the Development of Soluble TCR-Based Protein Biologics: Current Landscape, Control Strategy and Future Direction
AU - Jingyi Zhang
AU - Hongxin An
AU - Chuanfei Yu
AU - Weiyu Li
AU - Meng Li
AU - Lan Wang
PY - 2026
DA - 2026/10/04
JO - International Journal of Molecular Sciences
DO - 10.3390/ijms27198859
UR - https://www.mdpi.com/1422-0067/27/19/8859
AB - Soluble T-cell receptor (TCR)-based biologics (protein-based) are an emerging class of immunotherapeutic agents that recognize antigenic peptides presented by the human leukocyte antigen (HLA) on the surface of target cells. Furthermore, they simultaneously bind to cluster of differentiation 3 (CD3) subunits on T cells, recruit T cells to target cells, and promote T-cell activation and degranulation, ultimately eliminating tumor cells. Soluble TCR-based protein biologics target intracellular antigens that are inaccessible to conventional antibody-based drugs. Consequently, the development of soluble TCR-based protein biologics has generated significant interest. One soluble TCR-based protein biologic is already approved for marketing, and several other drugs are entering clinical stages. Soluble TCR-based protein biologics have substantial therapeutic benefits but may cause cytokine release syndrome (CRS), off-target toxicity, and drug resistance. This review outlines the structural characteristics and mechanisms of action of soluble TCR-based protein biologics, introduces nonclinical research concerning soluble TCR-based protein biologics, describes the clinical progress, discusses the quality control of TCR drugs, and explores the challenges and possible future improvements for soluble TCR-based protein biologics.
SN - 1422-0067
ER -