Evidence map›Paper›PMID 40803751›Full record

ArticleGut2025

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.

Xiang'an Wu, Dongmei Quan, Wei Li, Karin Wisskirchen, Wei Wu, Yuhong Zhou, Yun-Peng Liu, Xueshuai Wan, Xiaorui Wang, Xuxu Zhang and 6 more

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Gut, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05339321 (A Phase 1 Clinical Study of Autologous HBV-specific TCR-T Cell Therapy), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05339321 phase1unknown statusnot on this map

A Phase 1 Clinical Study of Autologous HBV-specific TCR-T Cell Therapy (SCG101) in Patients With HBV-related HCC

TypeinterventionalSponsorPeking Union Medical College HospitalRan2021 to 2023Enrolled36ConditionsHepatocellular CarcinomaArmsSCG101, PD1/PD-L1 checkpoint inhibitor
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors.

Xiang'an Wu *Department of Liver Surgery, Peking Union Medical College Hospital, Beijing, Beijing, China.ORCID 0009-0009-8729-8113
Dongmei Quan *Department of General Surgery, The Sixth People's Hospital of Shenyang, Shenyang, China.ORCID 0000-0002-5361-1484
Wei Li *Department of Medical Oncology, Zhongshan Hospital Fudan University, Shanghai, Shanghai, China.
Karin WisskirchenSCG Cell Therapy GmbH, Munich, Germany.ORCID 0000-0002-7447-4044
Wei WuDepartment of General Surgery, The Sixth People's Hospital of Shenyang, Shenyang, China.ORCID 0009-0007-4250-5559
Yuhong ZhouDepartment of Medical Oncology, Zhongshan Hospital Fudan University, Shanghai, Shanghai, China.ORCID 0000-0001-6333-8226
Yun-Peng LiuDepartment of Medical Oncology, The First Hospital of China Medical University, Shenyang, China.ORCID 0000-0002-9645-7990
Xueshuai WanDepartment of Liver Surgery, Peking Union Medical College Hospital, Beijing, Beijing, China.ORCID 0000-0003-2140-5384
Xiaorui WangSCG Cell Therapy Pte Ltd, Singapore.ORCID 0009-0003-6675-5094
Xuxu ZhangSCG (Shanghai) Cell Therapy Co Ltd, Shanghai, China.ORCID 0009-0005-2930-2322
Lu YangSCG (Shanghai) Cell Therapy Co Ltd, Shanghai, China.ORCID 0009-0005-1280-0413
Mengyao ZhengSCG (Shanghai) Cell Therapy Co Ltd, Shanghai, China.ORCID 0009-0000-3396-3434
Ke ZhangSCG Cell Therapy Pte Ltd, Singapore.ORCID 0000-0002-4595-7098
Ulrike ProtzerInstitute of Virology, Technical University of Munich / Helmholtz Munich, Munich, Germany protzer@tum.de dushd@pumch.cn qu_xiujuan@hotmail.com.ORCID 0000-0002-9421-1911
Shunda DuDepartment of Liver Surgery, Peking Union Medical College Hospital, Beijing, Beijing, China protzer@tum.de dushd@pumch.cn qu_xiujuan@hotmail.com.ORCID 0000-0002-9357-3259
Xiujuan QuDepartment of Medical Oncology, The First Hospital of China Medical University, Shenyang, China protzer@tum.de dushd@pumch.cn qu_xiujuan@hotmail.com.ORCID 0009-0005-9366-2314

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSCG101 is an autologous T-cell therapy specifically targeting hepatitis B virus (HBV) using a natural, high-affinity T-cell receptor that is stably expressed.

objectiveWe evaluated the safety, pharmacokinetics, pharmacodynamics and efficacy of SCG101 in patients with HBV-related hepatocellular carcinoma (HCC) in an investigator-initiated trial.

designSix 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 5×10

resultsWithin 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) log

conclusionAs 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.

Indexed as

Carcinoma, HepatocellularHepatitis BHepatitis B virusImmunotherapy, AdoptiveLiver NeoplasmsReceptors, Antigen, T-CellT-LymphocytesAdultAgedFemaleHumansMaleMiddle AgedTreatment OutcomeReceptors, Antigen, T-CellALPHA BETA T CELLSHEPATITIS BHEPATOCELLULAR CARCINOMAIMMUNOTHERAPY

Identifiers

PMID40803751
PMCPMC12703252

What Socratic holds

Textmetadata
LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.