Current status and perspective of off-the-shelf CAR-T cells in cancer immunotherapy

Biomed Pharmacother. 2026 Feb:195:118986. doi: 10.1016/j.biopha.2026.118986. Epub 2026 Jan 12.

Abstract

Recent advances in cancer immunotherapy have highlighted the promise of off-the-shelf chimeric antigen receptor (CAR)-T cell therapy. This has offered solutions to key limitations of conventional autologous approaches, such as patient-specific cell collection and lengthy production times. This review summarizes the development, clinical application, and challenges of CAR-T cell technology. We reviewed CAR design and function, cancer-targeting mechanisms, and approaches to developing universal donor platforms that could replace the need for patient-specific cell harvesting. We discussed key challenges of CAR-T technology and its potential solutions. This review also summarizes CAR-T cell therapies recently approved by the FDA. Finally, we explored future directions, regulatory challenges and the potential of personalized medicine, emphasizing how off-the-shelf CAR-T therapies could revolutionize cancer treatment by making it more scalable and accessible.

Keywords: Allogeneic CAR-T cells; Cancer immunotherapy; FDA-approved CAR-T cells; Immune rejection; Personalized cancer treatment; Regulatory landscape; Tumor heterogeneity; Universal CAR-T cells.

Publication types

  • Review

MeSH terms

  • Animals
  • Humans
  • Immunotherapy* / methods
  • Immunotherapy, Adoptive* / methods
  • Immunotherapy, Adoptive* / trends
  • Neoplasms* / immunology
  • Neoplasms* / therapy
  • Precision Medicine
  • Receptors, Chimeric Antigen* / immunology
  • T-Lymphocytes* / immunology
  • T-Lymphocytes* / transplantation

Substances

  • Receptors, Chimeric Antigen