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CAR-NK cell-based therapies: translational and regulatory breakthroughs
Alison Felipe Bordini Biggi1,2, Fernando Souza-Fonseca-Guimaraes1
1Frazer Institute, Faculty of Health, Medicine and Behavioural Sciences, The University of Queensland, Woolloongabba, QLD, Australia.
Abstract:
In this article for the "Highlights of 2025" series, we discuss advances in chimeric antigen receptor (CAR)-engineered natural killer (NK) cell therapies. We highlight iPSC-derived manufacturing, expansion into autoimmune disease, discovery of intrinsic regulators, and rational antigen targeting, illustrating how discovery-driven biology and engineering are reshaping CAR-NK therapies toward broader clinical applicability. Figure made in ©BioRender-biorender.com.
Insights
Chimeric antigen receptor (CAR)-engineered natural killer (NK) cell therapies are advancing rapidly. Key developments include iPSC-derived manufacturing and new applications in autoimmune diseases, expanding clinical potential.
Area of Science:
- Immunology
- Cell Therapy
- Biotechnology
Background:
- Chimeric antigen receptor (CAR)-engineered natural killer (NK) cell therapy represents a promising frontier in cancer immunotherapy and beyond.
- Significant challenges remain in manufacturing, efficacy, and expanding therapeutic applications.
Purpose of the Study:
- To review recent advancements in CAR-NK cell therapies.
- To highlight key areas of innovation including manufacturing, disease targets, and biological understanding.
- To discuss the potential for broader clinical applicability.
Main Methods:
- Review of recent scientific literature and research findings in CAR-NK cell therapy.
- Analysis of emerging trends in iPSC-derived manufacturing and autoimmune disease applications.
- Discussion of novel discoveries in intrinsic NK cell regulation and antigen targeting strategies.
Main Results:
- Induced pluripotent stem cell (iPSC)-derived manufacturing is improving scalability and consistency.
- CAR-NK therapies are showing potential beyond oncology, including in autoimmune diseases.
- Understanding intrinsic NK cell regulators and employing rational antigen targeting are enhancing efficacy.
Conclusions:
- Discovery-driven biology and engineering innovations are significantly reshaping CAR-NK therapies.
- These advancements are paving the way for broader clinical applicability of CAR-NK cell therapies.
- The field is rapidly evolving, promising new therapeutic options.

