Actively Recruiting
An Exploratory Study of Autologous CAR-T Cells Targeting Glypican-3 (CG-102-12C) for Advanced Hepatocellular Carcinoma
Led by Zhejiang University · Updated on 2026-01-22
12
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
C
Cells & Genes Biotech
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating CG-102-12C, a type of autologous chimeric antigen receptor T-cell therapy, in adults with advanced hepatocellular carcinoma (HCC) that tests positive for glypican-3 (GPC3). This exploratory, single-center study focuses on participants who have previously received systemic treatments that were ineffective or not tolerated. The goal is to assess safety, tolerability, dosing, anti-tumor effects, and how the drug behaves in the body. Participants will receive a single infusion of CG-102-12C in a dose-escalation design across three dose groups, with about 7 to 12 participants per group. The study is open-label and does not include a placebo group. The treatment phase examines different doses to identify the recommended dose and monitor immediate responses and side effects. During the study, participants will be closely monitored for dose-limiting toxicities within 28 days after infusion and treatment-emergent adverse events for up to 24 months. Researchers will assess tumor response, disease control, remission duration, progression-free and overall survival, and pharmacokinetic parameters over follow-up periods that may last up to five years. Participants will undergo lab tests, tumor evaluations by imaging, and other clinical assessments throughout the study period.
CONDITIONS
Brief Title
A Study to Evaluate CG-102-12C in Glypican-3 (GPC3) Positive Advanced Hepatocellular Carcinoma (HCC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has understood risks and benefits and signed consent.
- Age between 18 and 75 years.
- Confirmed advanced hepatocellular carcinoma with GPC3 positivity.
- Prior systemic standard treatment with failure or intolerance.
- Child-Pugh score 7 or less.
- At least one measurable tumor lesion.
- ECOG performance status 0-2.
- Expected survival of at least 3 months.
- Meets specific hematological parameters.
- Meets required blood biochemistry levels.
- Coagulation parameters within specified limits.
- If hepatitis B positive, HBV-DNA level 2000 IU/mL or below.
- Negative pregnancy test for women of childbearing potential and use of contraception during study and 1 year after.
You will not qualify if you...
- History of a second primary malignancy within 5 years, except certain treated cancers.
- Previous treatment with CAR-T or TCR-T therapies targeting any antigen or GPC3.
- Recent antitumor therapies within specified timeframes before apheresis.
- Unresolved toxicities from previous treatments above grade 1 (except specified exceptions).
- History or current organ transplantation.
- Brain metastases with symptoms or significant CNS diseases.
- History or presence of hepatic encephalopathy.
- Ascites requiring clinical intervention.
- Tumor volume occupying 50% or more of liver or tumor thrombus in major vessels.
- Pregnant or breastfeeding women.
- Positive for active hepatitis C, HIV, or syphilis.
- Severe underlying diseases including active infections, autoimmune diseases, uncontrolled diabetes, severe heart conditions, dementia, psychiatric disorders.
- Recent stroke or seizure within 6 months.
- Significant bleeding disorders.
- Use of systemic corticosteroids or immunosuppressants within 7 days before apheresis (with exceptions).
- Live attenuated vaccine within 4 weeks before apheresis.
- Major surgery within 2 weeks before apheresis or planned surgery during study.
- History of severe allergies or hypersensitivity relevant to the study.
- Any other condition deemed unsuitable by the investigator.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 28 days of CG-102-12C infusion
Participants receive infusion of CG-102-12C, a Chimeric Antigen Receptor Autologous T-cell therapy, to treat advanced hepatocellular carcinoma.
1 infusion visit and multiple monitoring visits within 28 days
Duration - Up to 24 months after treatment
Participants are monitored for safety and treatment effectiveness for up to 24 months after treatment, including assessments of adverse events and disease status.
Regular visits during 24 months post-treatment
Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
2
First Affiliated Hospital, Medical College of Zhejiang University
Hangzhou, Zhejiang, China, 310003
Not Yet Recruiting
Research Team
Q
Qi Zhang, Professor
F
Fan Yang
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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