Hepatitis B Virus Related Hepatocellular CarcinomaPhase 1/2TCR-TNCT05417932
A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
A Phase 1/2 study testing SCG101 in people with Hepatitis B Virus Related Hepatocellular Carcinoma and Hepatocellular Carcinoma Recurrent, run by SCG Cell Therapy Pte. Ltd. at 6 sites in 3 countries.
Trial summary
This Phase 1/ 2a study is a multicenter study to evaluate the safety, tolerability and efficacy of SCG101 in subjects with hepatitis B virus-related hepatocellular carcinoma Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis B Virus Related Hepatocellular Carcinoma, Hepatocellular Carcinoma Recurrent
- What is being tested?
- SCG101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 26 Oct 2022to Oct 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
Main Inclusion Criteria:
- Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)
- Subjects with HCC who have received at least 2 standard systemic therapies
- HLA-A *02
- BCLC stage B or C
- Child-pugh score ≤ 7
- Serum HBeAg negative, serum (or tumor tissue) HBsAg positive, and serum HBV-DNA must be 2 × 1000 IU/ml
- Have at least one measurable leasion at baseline as per mRECIST and RECIST v1.1 criteria
- Life expectancy of 3 months or greater
- Ability to provide informed consent form
- Ability to comply with all the study procedures
Main Exclusion Criteria:
- Subjects with history of another primary cancer
- Untreated or active central nervous system (CNS) or leptomeningeal metastasis, or history of hepatic encephalopathy, or other clinically significant CNS diseases
- Autoimmune diseases requiring immunosuppressive therapy (except topical medication) or subjects with significant persistent immune rejection
- Known history of neurological or mental disorder, including epilepsy or dementia
- Known history of positive results for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS)
- Prior exposure to any cell therapy such as, but not limited to killer (NK) cells, cytokine-induced killer (CIK) cells, dendritic cells (DC), cytotoxic T lymphocytes (CTL), stem cell therapy, CAR T/TCR T cell therapy
- Allergy to immunotherapy drugs and lymphodepleting chemotherapy (cyclophosphamide and fludarabine)
- Any subjects who cannot be evaluated by either triphasic liver CT or triphasic MRI because of allergy or other contraindication to both CT and MRI contrast agents
- Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
Trial locations and contacts
6 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 3 countries
United States2 sites, 2 recruiting
- Recruiting
New York
New York, New York, 10029
- Recruiting
New York
New York, New York, 10065
Hong Kong2 sites, 2 recruiting
- Not yet recruiting
Hong Kong is.
Hong Kong
- Recruiting
Hong Kong NT
Hong Kong
Singapore2 sites, 2 recruiting
- Recruiting
Singapore
Singapore, 169610
- Recruiting
Singapore
Singapore, 228510
About this study
Official title: A Phase 1/ 2a, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
This Phase 1/ 2a study is a multicenter study to evaluate the safety, tolerability and efficacy of SCG101 in subjects with hepatitis B virus-related hepatocellular carcinoma
Read the detailed description
This study will be conducted in 2 parts: In Phase 1 dose escalation, cohorts of 3-6 subjects each will be sequentially assigned to escalating dose level of SCG101. The recommended phase 2 dose (RP2D) will be selected based on the safety, PK/ PD and antitumor activities if the maximum tolerated dose (MTD) is not reached from the planned dose levels.
In Phase 2a, subjects will be enrolled to characterize the safety and evaluate the efficacy of SCG101.
- Being tested
- SCG101
- Keywords
- HCC, Hepatitis B Virus Related, HCC Recurrent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCG101Biological
Infusion of HBsAg-specific TCR autologous T cells at assigned dose levels.
| Study group | Role | What they receive |
|---|---|---|
| SCG101 | Experimental | This is a single arm study.
Patients will receive infusion and will be observed for dose limiting toxicity (DLT) over a 28-day period, and thereafter enter the progression free survival observation period and continuous long term survival follow up at time of disease progression. Receives: Biological: SCG101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of SCG101
Based on incidence of adverse events (AE) using NCI-CTCAE v5.0
Measured: Start of SCG101 infusion until 100 days post SCG101 infusion
Tumor response of SCG101 (Phase 2)
Measured: Start of SCG101 infusion until a complate response or partial response is observed, disease progression, and long term survival follow up up to 15 years
Secondary outcomes (4)
Preliminary clinical efficacy of SCG101
Objective response rate
Measured: Start of SCG101 infusion until a complete response or partial response is observed after 28 days from SCG101 infusion.
Antiviral activity before and after SCG101 infusion
Based on changes in serum levels of HBsAg
Measured: Start of SCG101 infusion and throughout DLT and PFS until disease progression, an average of 24 months.
Change in pharmacodynamic markers (PD) before and after SCG101 infusion
Based on changes in serum from the liver function
Measured: Start of SCG101 infusion and throughout DLT and PFS until disease progression, an average of 24 months.
Persistence of viral vector copy number (VCN) after SCG101 infusion
Measured: Start of SCG101 infusion until disease progression, an average of 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start26 Oct 2022
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B Virus Related Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- SCG101 in the Treatment of Subjects with Hepatitis B Virus-Related Hepatocellular Carcinoma
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SCG Cell Therapy Pte. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SCG Cell Therapeutics, Study director, SCG Cell Therapy Pte. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417932
- Sponsor's protocol ID
- SCG101-UR-103
- Acronym
- TCR-T
- Status last verified
- Feb 2025
- First submitted
- 24 May 2022
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/ 2a, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05417932
- Acronym / sponsor ID
- TCR-T / SCG101-UR-103
- Keywords
- HCC, Hepatitis B Virus Related, HCC Recurrent
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- SCG Cell Therapy Pte. Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 14 Jun 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.
This Phase 1/ 2a study is a multicenter study to evaluate the safety, tolerability and efficacy of SCG101 in subjects with hepatitis B virus-related hepatocellular carcinoma
Detailed description
This study will be conducted in 2 parts: In Phase 1 dose escalation, cohorts of 3-6 subjects each will be sequentially assigned to escalating dose level of SCG101. The recommended phase 2 dose (RP2D) will be selected based on the safety, PK/ PD and antitumor activities if the maximum tolerated dose (MTD) is not reached from the planned dose levels.
In Phase 2a, subjects will be enrolled to characterize the safety and evaluate the efficacy of SCG101.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- SCG101 in the Treatment of Subjects with Hepatitis B Virus-Related Hepatocellular Carcinoma
| Arm | Type | Receives |
|---|---|---|
| SCG101 | Experimental | Biological: SCG101This is a single arm study. Patients will receive infusion and will be observed for dose limiting toxicity (DLT) over a 28-day period, and thereafter enter the progression free survival observation period and continuous long term survival follow up at time of disease progression. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| SCG101Infusion of HBsAg-specific TCR autologous T cells at assigned dose levels. | Biological | SCG101 |
Primary outcome
Safety and tolerability of SCG101
Time frame: Start of SCG101 infusion until 100 days post SCG101 infusion
Based on incidence of adverse events (AE) using NCI-CTCAE v5.0
Tumor response of SCG101 (Phase 2)
Time frame: Start of SCG101 infusion until a complate response or partial response is observed, disease progression, and long term survival follow up up to 15 years
4 secondary outcomes
Preliminary clinical efficacy of SCG101
Time frame: Start of SCG101 infusion until a complete response or partial response is observed after 28 days from SCG101 infusion.
Antiviral activity before and after SCG101 infusion
Time frame: Start of SCG101 infusion and throughout DLT and PFS until disease progression, an average of 24 months.
Change in pharmacodynamic markers (PD) before and after SCG101 infusion
Time frame: Start of SCG101 infusion and throughout DLT and PFS until disease progression, an average of 24 months.
Persistence of viral vector copy number (VCN) after SCG101 infusion
Time frame: Start of SCG101 infusion until disease progression, an average of 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: No
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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.
SCG Cell Therapeutics study director
SCG Cell Therapy Pte. Ltd.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SCG101 in people with Hepatitis B Virus Related Hepatocellular Carcinoma and Hepatocellular Carcinoma Recurrent, run by SCG Cell Therapy Pte. Ltd. at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Hong Kong, Singapore. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SCG Cell Therapy ((65) 68297180, clinicaltrials@scgcell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of SCG101 (time frame: Start of SCG101 infusion until 100 days post SCG101 infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2025.