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They are associated with different safety challenges when compared to established therapeutics, such as small chemical entities or monoclonal antibodies, due to immunogenicity, off\u2010target effects and organ\u2010specific toxicities. This review evaluates the current clinical evidence on ATMP toxicity, highlighting key mechanisms of toxicity and describing approaches to risk management.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A scoping review was conducted using the MEDLINE and Embase databases to identify studies reporting toxicities associated with gene therapy medicinal products (GTMPs), somatic\u2010cell therapy medicinal products, tissue\u2010engineered products and combined ATMPs. Data were extracted and collated qualitatively, focusing on acute and chronic clinical toxicity.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Acute toxicity, such as cytokine release syndrome and immune effector cell\u2010associated neurotoxicity syndrome were most often reported in GTMPs, particularly chimeric antigen receptor T\u2010cell therapies. Chronic risks of GTMPs include genotoxicity and tumorigenicity, especially with high\u2010dose adeno\u2010associated virus\u2010based therapies. Somatic\u2010cell therapy medicinal products carry risks of immunological toxicity and tumour formation, particularly in stem cell\u2010based approaches. Tissue\u2010engineered products present challenges of biocompatibility, scaffold degradation and host integration. Management strategies to mitigate anticipated toxicity include preconditioning regimens, safer vector design, immunosuppressive therapies (e.g. tocilizumab) and long\u2010term monitoring.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>ATMPs offer significant therapeutic promise but require robust safety assessments and proactive risk management plans to address their complex potential toxicity profiles. Personalized approaches, advanced preclinical models and stringent regulatory oversight are essential to ensure these therapies fulfil their potential without compromising patient safety.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/bcp.70104","type":"journal-article","created":{"date-parts":[[2025,6,13]],"date-time":"2025-06-13T02:55:33Z","timestamp":1749783333000},"page":"2222-2240","source":"Crossref","is-referenced-by-count":5,"title":["The clinical toxicity of advanced therapy medicinal products"],"prefix":"10.1002","volume":"91","author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-4320-1785","authenticated-orcid":false,"given":"Fraser J. 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