Actively Recruiting
A Phase 1, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
Led by SCG Cell Therapy Pte. Ltd. · Updated on 2024-09-27
38
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating SCG101, a TCR-T cell therapy, for patients with Hepatitis B Virus-Related Hepatocellular Carcinoma (HBV-HCC). This Phase I clinical trial aims to assess the safety, tolerability, and preliminary effectiveness of SCG101 in treating this form of liver cancer. The study focuses on patients who have already received standard systemic therapies and meet specific disease and health criteria. Participants will receive SCG101 as an infusion of HBsAg-specific TCR autologous T cells at assigned dose levels. The study monitors the incidence of dose-limiting toxicities and adverse events such as cytokine release syndrome and neurotoxicity from the start of infusion until disease progression or up to 12 months. Additional assessments include the therapy's clinical efficacy, pharmacodynamic marker changes, and viral vector copy number persistence over an average of 24 months. During the trial, participants will undergo continuous safety and efficacy evaluations, including measuring tumor response using mRECIST and iRECIST criteria. Researchers will monitor organ function and viral markers closely. The total observation period extends until disease progression or for 12 to 24 months post-infusion, allowing comprehensive assessment of treatment effects and long-term safety.
CONDITIONS
Brief Title
A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)
- Subjects with HCC who have received standard systemic therapies
- HLA-A *02 positive
- BCLC stage B or C
- Child-Pugh score of 7 or less
- Serum HBeAg negative, serum or tumor tissue HBsAg positive, and serum HBV-DNA at or below 1 × 1000 IU/ml
- At least one measurable lesion at baseline per mRECIST and iRECIST
- Life expectancy of 3 months or greater
- Good organ function
You will not qualify if you...
- History of another primary cancer within 5 years
- Central nervous system metastasis or significant CNS disease
- Current or previous hepatic encephalopathy
- Symptomatic third space fluid accumulation
- Poorly controlled hypertension despite standard treatment
- Known neurological or mental disorders including epilepsy or dementia
- Active autoimmune diseases or significant immune rejection
- Prior exposure to cell therapies such as NK cells, CIK cells, dendritic cells, cytotoxic T lymphocytes, or stem cell therapy
- Positive tests for HCV RNA, HAV IgM antibody, HDV IgM antibody, or evidence of HEV infection
- Allergy to immunotherapy drugs or lymphodepleting chemotherapy (cyclophosphamide and fludarabine)
- Any condition deemed unsuitable for trial participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or 12 months post infusion
Participants receive an infusion of SCG101, which consists of HBsAg-specific TCR autologous T cells at assigned dose levels.
1 infusion visit and multiple follow-up visits during treatment
Duration - Up to an average of 24 months post infusion
Participants are monitored for adverse events, clinical efficacy, pharmacodynamics markers, and viral vector persistence after SCG101 infusion.
Multiple visits for safety and efficacy assessments
Trial Site Locations
Total: 7 locations
1
Beijing
Beijing, Beijing Municipality, China, 100020
Actively Recruiting
2
Guangzhou
Guangzhou, Guangdong, China, 510000
Actively Recruiting
3
Zhengzhou
Zhengzhou, Henan, China, 450003
Actively Recruiting
4
Changchun
Changchun, Jilin, China, 130000
Actively Recruiting
5
Shenyang
Shenyang, Liaoning, China, 110000
Actively Recruiting
6
Ji'nan
Ji'nan, Shandong, China, 250000
Actively Recruiting
7
Shanghai
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
S
SCG Cell Therapy
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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