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New treatment option for HCC
Official title A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related
ClinicalTrials.gov ID: NCT06617000
What this study is testing
What is SCG101?
SCG101 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hcc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase I clinical study aimed to assess the safety, tolerability, and efficacy of SCG101 monotherapy for patients with HBV-HCC.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)
- people with HCC who have received standard systemic therapies
- HLA-A \ 02
- BCLC stage B or C
- Child-pugh score ≤ 7 ol
You likely can't join if
- people 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...
- Known history of neurological or mental disorder, including epilepsy or dementia
See the full eligibility criteria
- Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)
- people 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
- 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.
- people 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Zhengzhou, Henan, China
- Changchun, Jilin, China
- Shenyang, Liaoning, China
- Ji'nan, Shandong, China
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Zhengzhou, Henan, China; Changchun, Jilin, China; Shenyang, Liaoning, China; Ji'nan, Shandong, China and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.