Evidence map›Paper›PMID 38808361›Full record

ArticleClinical and molecular hepatology2024

Genetically-modified, redirected T cells target hepatitis B surface antigen-positive hepatocytes and hepatocellular carcinoma lesions in a clinical setting.

Xueshuai Wan, Karin Wisskirchen, Tao Jin, Lu Yang, Xiaorui Wang, Xiang'an Wu, Fang Liu, Yu Wu, Christy Ma, Yong Pang and 4 more

Registry-linked trialAbstract read
In one paragraph

Article in Clinical and molecular hepatology, 2024. 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 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing 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

20 citing papers in PubMed.

  1. Article
  2. [Clinical significance and occurrence mechanism of hepatitis B virus DNA integration].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2026
    Review
  3. Article
  4. Article
  5. Review
  6. Review
  7. Review
  8. Adoptive T-cell therapy for virus-associated diseases.Clinical microbiology reviews · 2025
    Review
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Review
  15. Viral oncogenesis in cancer: from mechanisms to therapeutics.Signal transduction and targeted therapy · 2025
    Review
  16. Article
  17. Review
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Xueshuai WanDepartment of Liver Surgery, Peking Union Medical College Hospital, PUMC, and Chinese Academy of Medical Sciences, Beijing, P. R. China.
Karin WisskirchenSCG Cell Therapy Pte. Ltd., Singapore, Singapore.
Tao JinSCG Cell Therapy Pte. Ltd., Singapore, Singapore.
Lu YangSCG Cell Therapy Pte. Ltd., Singapore, Singapore.
Xiaorui WangSCG Cell Therapy Pte. Ltd., Singapore, Singapore.
Xiang'an WuDepartment of Liver Surgery, Peking Union Medical College Hospital, PUMC, and Chinese Academy of Medical Sciences, Beijing, P. R. China.
Fang LiuDepartment of Liver Surgery, Peking Union Medical College Hospital, PUMC, and Chinese Academy of Medical Sciences, Beijing, P. R. China.
Yu WuDepartment of Liver Surgery, Peking Union Medical College Hospital, PUMC, and Chinese Academy of Medical Sciences, Beijing, P. R. China.
Christy MaSCG Cell Therapy Pte. Ltd., Singapore, Singapore.
Yong PangSCG Cell Therapy Pte. Ltd., Singapore, Singapore.
Qi LiSCG Cell Therapy Pte. Ltd., Singapore, Singapore.
Ke ZhangSCG Cell Therapy Pte. Ltd., Singapore, Singapore.
Ulrike ProtzerInstitute of Virology, School of Medicine, Technical University of Munich/ Helmholtz Munich, Munich, Germany.
Shunda DuDepartment of Liver Surgery, Peking Union Medical College Hospital, PUMC, and Chinese Academy of Medical Sciences, Beijing, P. R. China.

Funding

Deutsche Forschungsgemeinschaft SFB-TRR 338/1 2021-452881907SCG Cell Therapy Pte. Ltd.
6 · The paper itself

Abstract

BACKGROUND/

aimsHepatitis 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 (S20-28) on HLA-A2. We here validated its safety and efficacy preclinically and applied it to an HBV-related HCC patient (NCT05339321).

methodsGood 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 7.9×107 cells/kg after lymphodepletion. Safety, T-cell persistence, and antiviral and antitumor efficacy were evaluated.

resultsSCG101, produced at high numbers in a closed-bag system, showed HBV-specific functionality against HBV-HCC cells in vitro and in vivo. 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 log10 and remained <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 >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's blood.

conclusionSCG101 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+ cells and achieve sustained tumor control after single dosing.

Indexed as

Carcinoma, HepatocellularHepatitis B Surface AntigensHepatitis B virusHepatocytesLiver NeoplasmsT-LymphocytesAnimalsHLA-A2 AntigenHumansMaleMiddle AgedReceptors, Antigen, T-CellHepatitis B Surface AntigensHLA-A2 AntigenReceptors, Antigen, T-CellCell therapyHepatitis B virusHepatocellular carcinomaImmunotherapyT cell receptor

Identifiers

PMID38808361
PMCPMC11540345

What Socratic holds

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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.