Abstract
Rapid advancements in the field of immunotherapy have significantly improved cancer treatments. Specifically, an individualized cell-based modality which involves the removal of some of the patient’s own white blood cells, including T cells, has revolutionized research in this field. This study focuses on the recent advances and current challenges of Chimeric Antigen Receptor- T (CAR-T) cell therapy and its regulations in the United States (US) and European Union (EU). Understanding the regulatory regimes of CAR-T cell therapy is critical for researchers and manufacturers as they navigate the hurdles of bringing CAR-T cell therapy to the global market. Benefits of CAR-T cell therapy include high response rates and the potential of long-term remissions in some haematological malignancies. However, the drawbacks are still evident including high costs, adverse reactions, and limited efficacy to solid tumours. CAR-T cell therapy is rapidly advancing, with 1231 clinical trials launched globally according to www.clinicalTrial.gov. The future of CAR-T cell therapy holds enormous promise but improving its safety, effectiveness, and availability are still barriers to its successful implementation.
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Adapted from Maakaron et al. (2022)
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Funding was provided by Irish Research Council for Science, Engineering and Technology (Grant no. GOIPG/2021/12571257).
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Joy, R., Phair, K., O’Hara, R. et al. Recent advances and current challenges in CAR-T cell therapy. Biotechnol Lett 46, 115–126 (2024). https://doi.org/10.1007/s10529-023-03461-0
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DOI: https://doi.org/10.1007/s10529-023-03461-0