Autologous HBV-specific T Cell Receptor Engineered T Cells (TCR-T) in Patients With HBV-related Advanced HCC
A Phase 1 Clinical Study of Autologous HBV-specific TCR-T Cell Therapy (SCG101) in Patients With HBV-related HCC
1 other identifier
interventional
36
1 country
4
Brief Summary
Adoptive cell therapy with TCR-T cells targeting HBV antigens represents an innovative opportunity for treatment of HBV-related HCC. SCG101 is a genetically modified autologous TCR-T cell therapy with a natural high-avidity TCR directed towards the HLA-A\*02-restricted HBsAg peptide. This is a phase 1 clinical study of SCG101 alone and with PD-1/PD-L1 checkpoint inhibitors in HBV-related HCC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 hepatocellular-carcinoma
Started Apr 2021
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 14, 2021
CompletedFirst Submitted
Initial submission to the registry
April 14, 2022
CompletedFirst Posted
Study publicly available on registry
April 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedMay 10, 2022
April 1, 2022
2.2 years
April 14, 2022
May 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of subjects with adverse events (AEs) and laboratory abnormalities defined as dose limiting toxicities (DLT)
To assess the tolerability of SCG101 and determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D)
28 days
Secondary Outcomes (2)
Efficacy: antitumor activity of SCG101 in subjects with HBV-related HCC
Up to 2 years
Efficacy: antiviral activity of SCG101
Up to 2 years
Study Arms (2)
SCG101
EXPERIMENTALSCG101 will be given via Intravenous (IV) infusion.
SCG101 + PD1/PD-L1 checkpoint inhibitor
EXPERIMENTALSCG101 will be given via Intravenous (IV) infusion. The PD-1/PD-L1 checkpoint inhibitor will be given per product label.
Interventions
SCG101 is an autologous HBV-specific T cell receptor engineered T cell therapy.
Commercially approved for HCC treatment.
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed, or imaging diagnosed HCC
- HLA-A \*02 genotyping
- HBsAg positive in serum or tumor tissue
- Have at least one measurable lesion at baseline as per mRECIST and RECIST v1.1 criteria
- Child-Pugh score ≤ 7
- ECOG performance status of 0 or 1
- Life expectancy of 3 months or greater
- Patient with adequate organ function
You may not qualify if:
- Uncontrolled portal vein or inferior vena cava tumor thrombosis
- Untreated or active Central nervous system (CNS) metastasis or other clinically significant CNS diseases
- Active or uncontrollable infections
- History of organ transplantation
- Lack of peripheral or central venous access or any condition that would interfere with study drug administration or collection of study sample
- History of positive results for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS)
- Prior exposure to any cell therapy
- Other severe medical conditions that may limit subject's participation in this trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Peking Union Medical College Hospital
Beijing, China
Zhongshan Hospital, Fudan University
Shanghai, China
The First Hospital of China Medical University
Shenyang, China
The Sixth People's Hospital of Shenyang
Shenyang, China
Related Publications (2)
Wu X, Quan D, Li W, Wisskirchen K, Wu W, Zhou Y, Liu YP, 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. 2025 Dec 5;75(1):147-160. doi: 10.1136/gutjnl-2025-335456.
PMID: 40803751DERIVEDWan X, Wisskirchen K, Jin T, Yang L, Wang X, Wu X, Liu F, Wu Y, Ma C, Pang Y, Li Q, Zhang K, Protzer U, Du S. Genetically-modified, redirected T cells target hepatitis B surface antigen-positive hepatocytes and hepatocellular carcinoma lesions in a clinical setting. Clin Mol Hepatol. 2024 Oct;30(4):735-755. doi: 10.3350/cmh.2024.0058. Epub 2024 May 29.
PMID: 38808361DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shunda Du
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2022
First Posted
April 21, 2022
Study Start
April 14, 2021
Primary Completion
July 1, 2023
Study Completion
December 1, 2023
Last Updated
May 10, 2022
Record last verified: 2022-04