HCCPhase 1NCT06617000
A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related
A Phase 1 study testing SCG101 in people with HCC and Hepatitis B Virus Related Hepatocellular Carcinoma, run by SCG Cell Therapy Pte. Ltd. at 7 sites in China.
Trial summary
This is a Phase I clinical study aimed to assess the safety, tolerability, and efficacy of SCG101 monotherapy for patients with HBV-HCC. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HCC, Hepatitis B Virus Related Hepatocellular Carcinoma, Hepatocellular Carcinoma
- 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
- 38 participants
- Where
- 7 sitesChina
- Study dates
- 25 Oct 2022to 31 Dec 2025
- 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 Hepatocellular carcinoma (HCC)
- Subjects with HCC who have received standard systemic therapies
- HLA-A *02
- BCLC stage B or C
- Child-pugh score ≤ 7 ol
- Serum HBeAg negative, serum (or tumor tissue) HBsAg positive, and serum HBV-DNA must be ≤ 1 × 1000 IU/ml
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- Have at least one measurable leasion at baseline as per mRECIST and iRECIST
- Life expectancy of 3 months or greater
- The organ function is in good condition.
Who cannot join
- Subjects with history of another primary cancer within 5 years
- Central nervous system metastasis and clinically significant central nervous system disease
- Previous or current coexistence of hepatic encephalopathy
- Currently present with symptomatic third space fluid accumulation
- Hypertension that is poorly controlled, as determined by researchers (i.e., arterial hypertension that remains uncontrolled despite standard treatment)
- Known history of neurological or mental disorder, including epilepsy or dementia
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- Suffering from active autoimmune diseases, or other significant ongoing immune rejection based on pathology and clinical diagnosis
- 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
- Positive for HCV - RNA test or positive for HAV IgM antibody or positive for HDV IgM antibody; or there is current evidence indicating the presence of HEV infection
- Allergy to immunotherapy drugs and lymphodepleting chemotherapy (cyclophosphamide and fludarabine)
- Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Beijing
Beijing, Beijing Municipality, 100020
- Recruiting
Changchun
Changchun, Jilin, 130000
- Recruiting
Guangzhou
Guangzhou, Guangdong, 510000
- Recruiting
Ji'nan
Ji'nan, Shandong, 250000
- Recruiting
Shanghai
Shanghai, Shanghai Municipality, 200000
- Recruiting
Shenyang
Shenyang, Liaoning, 110000
- Recruiting
Zhengzhou
Zhengzhou, Henan, 450003
About this study
Official title: A Phase 1, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
This is a Phase I clinical study aimed to assess the safety, tolerability, and efficacy of SCG101 monotherapy for patients with HBV-HCC.
- Being tested
- SCG101
- Medical subject headings
- Carcinoma, Hepatocellular
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 | Not described Receives: Biological: SCG101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity (DLT) and adverse events (AEs), including serious AEs (SAEs), cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS).
Based on incidence of adverse events (AE) using NCI-CTCAE v5.0 and ASTCT criteria
Measured: Start of SCG101 infusion until disease progression or 12 months post infusion
The preliminary clinical efficacy of SCG101, including objective response rate (ORR), disease control rate (DCR), duration of response (DoR), time to response (TTR), progression-free survival (PFS), and overall survival (OS).
Per mRECIST and iRECIST
Measured: Start of SCG101 infusion until disease progression or 12 months post infusion
Change in pharmacodynamics markers (PD) before and after SCG101 infusion
Based on changes in serum liver function markers, including HBsAg, ALT, AST, and AFP
Measured: Start of SCG101 infusion until disease progression, an average of 24 months
Persistences 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 posted27 Sep 2024
- Study start25 Oct 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SCG Cell Therapy Pte. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617000
- Sponsor's protocol ID
- SCG-101-CR-102
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06617000
- Acronym / sponsor ID
- SCG-101-CR-102
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- SCG Cell Therapy Pte. Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Sep 2024 (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 is a Phase I clinical study aimed to assess the safety, tolerability, and efficacy of SCG101 monotherapy for patients with HBV-HCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCG101 | Experimental | Biological: SCG101 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)
- Subjects with HCC who have received standard systemic therapies
- HLA-A *02
- BCLC stage B or C
- Child-pugh score ≤ 7 ol
Key exclusion criteria (11 listed)
- Subjects with history of another primary cancer within 5 years
- Central nervous system metastasis and clinically significant central nervous system disease
- Previous or current coexistence of hepatic encephalopathy
- Currently present with symptomatic third space fluid accumulation
- Hypertension that is poorly controlled, as determined by researchers (i.e., arterial hypertension that remains uncontrolled despite standard treatment)
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
Incidence of dose-limiting toxicity (DLT) and adverse events (AEs), including serious AEs (SAEs), cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS).
Time frame: Start of SCG101 infusion until disease progression or 12 months post infusion
Based on incidence of adverse events (AE) using NCI-CTCAE v5.0 and ASTCT criteria
The preliminary clinical efficacy of SCG101, including objective response rate (ORR), disease control rate (DCR), duration of response (DoR), time to response (TTR), progression-free survival (PFS), and overall survival (OS).
Time frame: Start of SCG101 infusion until disease progression or 12 months post infusion
Per mRECIST and iRECIST
Change in pharmacodynamics markers (PD) before and after SCG101 infusion
Time frame: Start of SCG101 infusion until disease progression, an average of 24 months
Based on changes in serum liver function markers, including HBsAg, ALT, AST, and AFP
Persistences 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
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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.
7 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 in people with HCC and Hepatitis B Virus Related Hepatocellular Carcinoma, run by SCG Cell Therapy Pte. Ltd. at 7 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 9 inclusion and 11 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 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 SCG Cell Therapy (021-50339500, clinicaltrials@scgcell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicity (DLT) and adverse events (AEs), including serious AEs (SAEs), cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS). (time frame: Start of SCG101 infusion until disease progression or 12 months post infusion). The study lists 4 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 27 Sep 2024.