Literature Review on the Development Trends of Gene-Modified Cell Therapies:Focusing on clinical studies of TCR-T cell therapy
10.24304/kjcp.2025.35.1.1
- Author:
Jongyoon KIM
1
;
Hyang-Mi LEE
Author Information
1. Department of Pharmacy, Dongduk Women’s University, Seoul 02748, Republic of Korea
- Publication Type:Review Article
- From:Korean Journal of Clinical Pharmacy
2025;35(1):1-12
- CountryRepublic of Korea
- Language:English
-
Abstract:
Immunotherapy has transformed cancer treatment in the past decade, with combinations of immune checkpoint inhibitors and conventional therapies showing promise across various cancers. This study reviews ongoing clinical trials of T cell receptor-T cell (TCR-T) therapies, analyzing their potential in targeting key cancer antigens for future treatment advancements. We examined data from ClinicalTrials.gov, focusing on phase 1-4 trials with reported results up to August 31, 2024. Trials wereselected based on relevance to TCR-T cell therapy, safety and efficacy evaluation, and predefined inclusion/exclusion criteria.Thirty-three TCR-T clinical trials were identified, with 17 focusing on advanced cancers. Target antigens included New Yorkesophageal squamous cell carcinoma (16 trials), melanoma-associated antigen (5 trials), and human papillomavirus 16 E (4trials). Most studies targeted adults, with three involving pediatric patients. Sponsors included the National Cancer Institute andGlaxoSmithKline, with melanoma being the most studied cancer. One trial (NCT05066165) utilized CRISPR/Cas9 for non-viral TCR gene editing. Recent FDA approval of afamitresgene autoleucel, the first gene-modified TCR-T cell therapy targeting solid tumors, marks a significant milestone. TCR-T therapies are evolving into personalized cancer treatments, with shared antigenbased therapies leading development. The introduction of CRISPR technology is expected to enhance the efficiency and safety of gene-modified therapies, shaping the future of cancer immunotherapy. This review highlights the rapidly advancing field ofTCR-T cell therapies and their potential to revolutionize cancer treatment.
