Hepatocellular CarcinomaPhase 1NCT05339321
Autologous HBV-specific T Cell Receptor Engineered T Cells (TCR-T) in Patients With HBV-related Advanced HCC
A Phase 1 study testing SCG101 and PD1/PD-L1 checkpoint inhibitor in people with Hepatocellular Carcinoma, run by Peking Union Medical College Hospital at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- SCG101 and PD1/PD-L1 checkpoint inhibitor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 4 sitesChina
- Study dates
- 14 Apr 2021to Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Shunda Du
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai
Yuhong Zhou, Doctor
- Recruiting
The First Hospital of China Medical University
Shenyang
Yunpeng Liu
- Recruiting
The Sixth People's Hospital of Shenyang
Shenyang
Wei Wu
About this study
Official title: A Phase 1 Clinical Study of Autologous HBV-specific TCR-T Cell Therapy (SCG101) in Patients With HBV-related HCC
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.
Read the detailed description
This is an open-label, multi-center clinical study to evaluate the safety, tolerability and effectiveness of SCG101, with and without PD-1/PD-L1 checkpoint inhibitors, in patients with HBV-related HCC. Lymphodepleting regimen of cyclophosphamide and fludarabine will be given prior to SCG101 infusion.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- SCG101, PD1/PD-L1 checkpoint inhibitor
- Keywords
- HCC
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCG101Genetic
SCG101 is an autologous HBV-specific T cell receptor engineered T cell therapy.
PD1/PD-L1 checkpoint inhibitorBiological
Commercially approved for HCC treatment.
| Study group | Role | What they receive |
|---|---|---|
| SCG101 | Experimental | SCG101 will be given via Intravenous (IV) infusion. Receives: Genetic: SCG101 |
| SCG101 + PD1/PD-L1 checkpoint inhibitor | Experimental | SCG101 will be given via Intravenous (IV) infusion. The PD-1/PD-L1 checkpoint inhibitor will be given per product label. Receives: Genetic: SCG101; Biological: PD1/PD-L1 checkpoint inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 28 days
Secondary outcomes (2)
Efficacy: antitumor activity of SCG101 in subjects with HBV-related HCC
Tumor response assessment in accordance with mRECIST and iRECIST
Measured: Up to 2 years
Efficacy: antiviral activity of SCG101
Changes in serum levels of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV-DNA) before and after SCG101 infusion
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start14 Apr 2021
- Primary completionJul 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shunda Du, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339321
- Sponsor's protocol ID
- SCG101-CI-101
- Status last verified
- Apr 2022
- First submitted
- 14 Apr 2022
- Last updated
- 10 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40803751Wan 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.
PubMed 38808361
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study of Autologous HBV-specific TCR-T Cell Therapy (SCG101) in Patients With HBV-related HCC
- ClinicalTrials.gov ID
- NCT05339321
- Acronym / sponsor ID
- SCG101-CI-101
- Conditions
- Hepatocellular Carcinoma
- Keywords
- HCC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label, multi-center clinical study to evaluate the safety, tolerability and effectiveness of SCG101, with and without PD-1/PD-L1 checkpoint inhibitors, in patients with HBV-related HCC. Lymphodepleting regimen of cyclophosphamide and fludarabine will be given prior to SCG101 infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCG101 | Experimental | Genetic: SCG101SCG101 will be given via Intravenous (IV) infusion. |
| SCG101 + PD1/PD-L1 checkpoint inhibitor | Experimental | Genetic: SCG101, Biological: PD1/PD-L1 checkpoint inhibitorSCG101 will be given via Intravenous (IV) infusion. The PD-1/PD-L1 checkpoint inhibitor will be given per product label. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCG101SCG101 is an autologous HBV-specific T cell receptor engineered T cell therapy. | Genetic | SCG101, SCG101 + PD1/PD-L1 checkpoint inhibitor |
| PD1/PD-L1 checkpoint inhibitorCommercially approved for HCC treatment. | Biological | SCG101 + PD1/PD-L1 checkpoint inhibitor |
Primary outcome
Number of subjects with adverse events (AEs) and laboratory abnormalities defined as dose limiting toxicities (DLT)
Time frame: 28 days
To assess the tolerability of SCG101 and determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D)
2 secondary outcomes
Efficacy: antitumor activity of SCG101 in subjects with HBV-related HCC
Time frame: Up to 2 years
Efficacy: antiviral activity of SCG101
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Derived from this study: PubMed 40803751Wu 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.
- Derived from this study: PubMed 38808361Wan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shunda Du principal investigator
Peking Union Medical College Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SCG101 and PD1/PD-L1 checkpoint inhibitor in people with Hepatocellular Carcinoma, run by Peking Union Medical College Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shunda Du, Doctor (+86-10-69156114, dushd@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse events (AEs) and laboratory abnormalities defined as dose limiting toxicities (DLT) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05339321, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.