Literature Review on the Development Trends of Gene-Modified Cell Therapies: Focusing on clinical studies of TCR-T cell therapy

• Published in: Korean Journal of Clinical Pharmacy Vol. 35; no. 1; pp. 1 - 12
• Main Authors: Kim, Jongyoon, Lee, Hyang-Mi
• Format: Journal Article
• Language: English
• Published: 한국임상약학회 31.03.2025
• Subjects: 약학
• ISSN: 1226-6051; 2508-786X
• DOI: 10.24304/kjcp.2025.35.1.1

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 were selected 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 York esophageal squamous cell carcinoma (16 trials), melanoma-associated antigen (5 trials), and human papillomavirus 16 E (4 trials). Most studies targeted adults, with three involving pediatric patients. Sponsors included the National Cancer Institute and GlaxoSmithKline, 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 of TCR-T cell therapies and their potential to revolutionize cancer treatment. KCI Citation Count: 0