PuSH - Publication Server of Helmholtz Zentrum München: Clinical results of an HBV-specific T-cell receptor-T-cell therapy (SCG101) in patients with HBV-related hepatocellular carcinoma treated in an investigator-initiated, interventional trial.

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Wu, X.* ; Quan, D.* ; Li, W.* ; Wisskirchen, K.* ; Wu, W.* ; Zhou, Y.* ; Liu, Y.P.* ; Wan, X.* ; Wang, X.* ; Zhang, X.* ; Yang, L.* ; Zheng, M.* ; Zhang, K.* ; Protzer, U. ; Du, S.* ; Qu, X.*

Clinical results of an HBV-specific T-cell receptor-T-cell therapy (SCG101) in patients with HBV-related hepatocellular carcinoma treated in an investigator-initiated, interventional trial.

Gut, DOI: 10.1136/gutjnl-2025-335456 (2025)

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BACKGROUND: SCG101 is an autologous T-cell therapy specifically targeting hepatitis B virus (HBV) using a natural, high-affinity T-cell receptor that is stably expressed. OBJECTIVE: We evaluated the safety, pharmacokinetics, pharmacodynamics and efficacy of SCG101 in patients with HBV-related hepatocellular carcinoma (HCC) in an investigator-initiated trial. DESIGN: Six human leucocyte antigen (HLA)-A*02:01-positive, serum hepatitis B surface antigen (HBsAg)-positive and hepatitis B e antigen-negative patients with advanced HBV-HCC, who had failed one to three prior systemic therapies, received SCG101 at doses of 5×10⁷ or 1×10⁸ TCR-T⁺ cells/kg three days after lymphodepletion. RESULTS: Within 1 week, all patients experienced a significant but transient alanine aminotransferase elevation paralleled by a 76±57 fold expansion of T cells detected in peripheral blood. No neurotoxicity, but a cytokine release syndrome reaching up to grade 3 was observed. However, these side effects were not dose-limiting and could be managed with corticosteroids, anti-interleukin-6 and/or vasopressor therapy. Indicating on-target activity of SCG101, serum HBsAg levels dropped by 1.96 (0.16-3.84) log₁₀ within 2 weeks. According to modified Response Evaluation Criteria in Solid Tumours, three of the six patients achieved tumour shrinkage with a best percentage change in target lesion size of -19.5%, -74.6% and -100%. One showed complete remission of the target lesion, remaining progression-free for 27 months and one other achieved a durable (>6 months) remission. During follow-up (median 10.9 months), three patients died, and one was lost to follow-up. CONCLUSION: As monotherapy for patients with HBV-HCC, SCG101 demonstrated pronounced antiviral and antitumour activities and a safety profile manageable with supportive care. SCG101's T-cell expansion, serum HBsAg drop and tumour response collectively underscore on-target activity. TRIAL REGISTRATION NUMBER: NCT05339321.

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