{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T18:29:38Z","timestamp":1793212178889,"version":"4.5.0"},"reference-count":61,"publisher":"The Korean Association for the Study of the Liver","issue":"4","license":[{"start":{"date-parts":[[2024,5,29]],"date-time":"2024-05-29T00:00:00Z","timestamp":1716940800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/3.0\/"}],"funder":[{"name":"SCG Cell Therapy Pte. Ltd."},{"DOI":"10.13039\/501100001659","name":"Deutsche Forschungsgemeinschaft","doi-asserted-by":"publisher","award":["SFB-TRR 338\/1 2021\u2013452881907"],"award-info":[{"award-number":["SFB-TRR 338\/1 2021\u2013452881907"]}],"id":[{"id":"10.13039\/501100001659","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["e-cmh.org"],"crossmark-restriction":true},"short-container-title":["Clin Mol Hepatol"],"published-print":{"date-parts":[[2024,10,1]]},"abstract":"<jats:p>Background\/Aims: Hepatitis B virus (HBV)-DNA integration in HBV-related hepatocellular carcinoma (HBV-HCC) can be targeted by HBV-specific T cells. SCG101 is an autologous, HBV-specific T-cell product expressing a T-cell receptor (TCR) after lentiviral transduction recognizing the envelope-derived peptide (S&lt;sub&gt;20-28&lt;\/sub&gt;) on HLA-A2. We here validated its safety and efficacy preclinically and applied it to an HBV-related HCC patient (NCT05339321).Methods: Good Manufacturing Practice-grade manufactured cells were assessed for off-target reactivity and functionality against hepatoma cells. Subsequently, a patient with advanced HBV-HCC (Child-Pugh class A, Barcelona Clinic Liver Cancer stage B, Eastern Cooperative Oncology Group performance status 0, hepatitis B e antigen-, serum hepatitis B surface antigen [HBsAg]+, HBsAg+ hepatocytes 10%) received 7.9\u00d710&lt;sup&gt;7&lt;\/sup&gt; cells\/kg after lymphodepletion. Safety, T-cell persistence, and antiviral and antitumor efficacy were evaluated.Results: SCG101, produced at high numbers in a closed-bag system, showed HBV-specific functionality against HBV-HCC cells &lt;i&gt;in vitro&lt;\/i&gt; and &lt;i&gt;in vivo&lt;\/i&gt;. Clinically, treatment was well tolerated, and all adverse events, including transient hepatic damage, were reversible. On day 3, ALT levels increased to 1,404 U\/L, and concurrently, serum HBsAg started decreasing by 3.84 log&lt;sup&gt;10&lt;\/sup&gt; and remained &lt;1 IU\/mL for over six months. HBsAg-expressing hepatocytes in liver biopsies were undetectable after 73 days. The patient achieved a partial response according to modified RECIST with a &gt;70% reduction in target lesion size. Transferred T cells expanded, developed a stem cell-like memory phenotype, and were still detectable after six months in the patient\u2019s blood.Conclusions: SCG101 T-cell therapy showed encouraging efficacy and safety in preclinical models and in a patient with primary HBV-HCC and concomitant chronic hepatitis B with the capability to eliminate HBsAg&lt;sup&gt;+&lt;\/sup&gt; cells and achieve sustained tumor control after single dosing.<\/jats:p>","DOI":"10.3350\/cmh.2024.0058","type":"journal-article","created":{"date-parts":[[2024,5,29]],"date-time":"2024-05-29T07:31:06Z","timestamp":1716967866000},"page":"735-755","update-policy":"https:\/\/doi.org\/10.3350\/crossmark_policy","source":"Crossref","is-referenced-by-count":31,"title":["Genetically-modified, redirected T cells target hepatitis B surface antigen-positive hepatocytes and hepatocellular carcinoma lesions in a clinical 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