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Advanced Hepatocellular Carcinoma (HCC)NCT07039201

A Study to Evaluate CG-102-12C in Glypican-3 (GPC3) Positive Advanced Hepatocellular Carcinoma (HCC)

A study testing CG-102-12C in people with Advanced Hepatocellular Carcinoma (HCC), run by Zhejiang University at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is a single-centre, single-arm, open-label, dose-escalation exploratory study with single-dose administration. Its objective is to evaluate the safety, tolerability, dose, anti-tumor efficacy, and pharmacokinetic characteristics of CG-102-12C in the participants with GPC3-positive advanced hepatocellular… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Hepatocellular Carcinoma (HCC)
What is being tested?
CG-102-12C
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesChina
Study dates
28 Jun 2025to 31 Jul 2027
Phase
Interventional
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. The study participant has fully understood the potential risks and benefits of participating in this study and has signed the informed consent form.
  • 2. Aged 18-75 years (inclusive of 18 and 75 years old).
  • 3. Patients with advanced hepatocellular carcinoma (HCC) confirmed by histopathological or cytological examination to be GPC3-positive (advanced HCC is defined as Barcelona Clinic Liver Cancer (BCLC) stage C or stage B that is unsuitable for or has progressed after local treatment, including ablation therapy, interventional therapy, and radiotherapy). Patients must have previously received systemic standard treatment and experienced treatment failure or intolerance (systemic treatments include, but are not limited to, chemotherapy and molecular targeted therapy). Treatment failure is defined as disease progression during or after the most recent treatment.
  • 4. Immunohistochemical analysis of tumor tissue samples must show GPC3 positivity (defined as >25% of pathological specimens with IHC-detected GPC3-positive cells and staining intensity ≥1+). Preferably ,target lesion specimens will be used, including freshly obtained tumor pathology samples or archived tumor pathology samples deemed acceptable by the investigator.
  • 5. Child-Pugh score ≤7.
  • 6. At least one evaluable tumor lesion as assessed by RECIST 1.1.
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  • 7. ECOG performance status score of 0-2.
  • 8. Expected survival ≥3 months.
  • 9. Hematological parameters must meet the following criteria:Absolute neutrophil count (ANC) ≥1×10^9/L;Absolute lymphocyte count (ALC) ≥0.5×10^9/L;Platelets ≥50×10^9/L;Hemoglobin ≥60 g/L or hematocrit >0.24.(No treatment with hematopoietic growth factors or blood transfusion within 3 days prior to laboratory tests).
  • 10.Blood biochemistry must meet the following criteria:Total bilirubin (TBIL) ≤2.5 times the upper limit of normal (ULN);AST and ALT ≤5.0 times ULN;Serum albumin ≥28 g/L;Serum creatinine ≤1.5 times ULN;Creatinine clearance >50 mL/min (calculated using the Cockcroft-Gault formula).
  • 11.Coagulation parameters must meet the following criteria:INR <1.5 times ULN;APTT <1.5 times ULN;PT prolongation ≤4 seconds.
  • 12.If the patient is HBsAg positive or HBcAb positive, it is required that HBV-DNA ≤2000 IU/mL;
  • 13.At screening, during apheresis, and within 3 days prior to preconditioning, female study participants of childbearing potential must have a negative blood pregnancy test; during the study period and for at least 1 year after completion of the study treatment, study participants of childbearing potential and their partners must use effective contraception.

Who cannot join

  • 1. History of a second primary malignancy is permitted, unless the patient has undergone potentially curative treatment and has been free of the disease for 5 years.
  • Note: This time requirement (i.e., within 5 years) does not apply to patients with adequately treated carcinoma in situ of the cervix, localized squamous cell carcinoma of the skin, basal cell carcinoma, localized prostate cancer, ductal carcinoma in situ of the breast, or urothelial carcinoma <T1. Patients with prostate cancer under active surveillance are also eligible, or patients deemed eligible by the investigator after thorough evaluation.
  • 2. Prior treatment with CAR-T or TCR-T cell therapy targeting any antigen or therapeutic cancer vaccines; or prior treatment with any therapy targeting GPC3.
  • 3. Prior to apheresis, the patient has received the following antitumor therapies: Cytotoxic therapy within 14 days; Small molecule targeted therapy, epigenetic therapy, or experimental drug therapy within 14 days or at least 5 half-lives (whichever is longer), or treatment with invasive experimental medical devices; Monoclonal antibody therapy within 21 days; Immunomodulatory therapy within 7 days; Radiotherapy within 14 days.
  • 4. Toxicities from prior antitumor therapies have not recovered to ≤ Grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 5.0), except for alopecia, Grade 2 peripheral neuropathy, and hypothyroidism controlled by hormone replacement therapy.
  • 5. History of organ transplantation or currently awaiting organ transplantation (including liver transplantation).
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  • 6. Brain metastases with central nervous system symptoms or other clinically significant central nervous system diseases.
  • 7. History of hepatic encephalopathy or current presence of hepatic encephalopathy.
  • 8. Ascites requiring therapeutic intervention (excluding any ascites detected by imaging that does not require clinical intervention).
  • 9. HCC tumor volume occupying ≥50% of the normal liver volume based on imaging, or presence of tumor thrombus in the main portal vein or inferior vena cava, or patients deemed ineligible by the investigator.
  • 10.Women who are pregnant or breastfeeding.
  • 11.Positive screening for hepatitis C virus antibody (HCV-Ab) or human immunodeficiency virus antibody (HIV-Ab); active syphilis. (Patients with positive HCV antibody but HCV-RNA below the detection limit of the research center are allowed to enroll).
  • 12.Presence of severe underlying diseases, such as: Evidence of severe active viral, bacterial, or uncontrolled systemic fungal infections; Active or unstable autoimmune diseases or a history of autoimmune diseases within the past 3 years with potential for recurrence (including, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; childhood asthma that has completely resolved and requires no intervention in adulthood may be included; asthma requiring medical intervention with bronchodilators is excluded); Uncontrolled diabetes; Severe congestive heart failure classified as New York Heart Association (NYHA) Class III or above, or patients with an ejection fraction <50%; history of myocardial infarction or unstable angina within 6 months prior to treatment; Hypertension that cannot be controlled to the following range (systolic blood pressure <160 mmHg, diastolic blood pressure <100 mmHg) despite treatment with two antihypertensive medications; Clinically significant ventricular arrhythmias, or a history of unexplained syncope not due to vasovagal causes or dehydration; patients with constrictive pericarditis, significant pericardial effusion, cardiomyopathy, low voltage on limb leads of electrocardiogram, or other cardiac conditions deemed unsuitable by the investigator; Patients with clinically significant dementia, altered mental status, or a history of poorly controlled psychiatric disorders.
  • 13.History of stroke or seizure within 6 months prior to signing the ICF.
  • 14.Significant bleeding tendency, such as active gastrointestinal bleeding or coagulation disorders.
  • 15.Chronic diseases requiring systemic corticosteroids or other immunosuppressive therapy, or treatment with systemic corticosteroids (≥70 mg prednisone or equivalent doses of other corticosteroids) or other immunosuppressive agents within 7 days prior to apheresis, except for the following: use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term use of corticosteroids for prophylactic purposes (e.g., prevention of contrast agent allergy).
  • 16.Administration of live attenuated vaccines within 4 weeks prior to apheresis.
  • 17.Major surgery within 2 weeks prior to apheresis, or planned surgery during the study period (Note: Study participants scheduled for local anesthesia surgery may participate in this study).
  • 18.History of severe allergic reactions, or hypersensitivity to any drugs or related excipients specified in the protocol, as determined by the investigator to be unsuitable for enrollment.
  • 19.Any condition that, in the opinion of the investigator, makes the study participant unsuitable for participation in this study.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Qi Zhang, Professor contact

0571-87233418 ext. 086-1381913711

qi.zhang@zju.edu.cn

Fan Yang contact

+86 18811588022

18811588022@163.com

China2 sites, 2 recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

    Tingbo Liang, Professor, 0571-87233418, liangtingbo@zju.edu.cn

    Recruiting

  • First Affiliated Hospital, Medical College of Zhejiang University

    Hangzhou, Zhejiang, 310003

    Tingbo Liang, MD,PHD, 086-571-87236688, liangtingbo@zju.edu.cn

    Not yet recruiting

Other trials in China

About this study

Official title: An Exploratory Clinical Study on the Safety and Efficacy of Autologous Chimeric Antigen Receptor T Cells Targeting Glypican-3 (CG-102-12C) in the Treament of Advanced Hepatocellular Carcinoma

This study is a single-centre, single-arm, open-label, dose-escalation exploratory study with single-dose administration. Its objective is to evaluate the safety, tolerability, dose, anti-tumor efficacy, and pharmacokinetic characteristics of CG-102-12C in the participants with GPC3-positive advanced hepatocellular carcinoma who previously received adequate but uneffective systemic standard treatments.

Read the detailed description

This study is a single-centre, open-label, dose-escalation exploratory clinical trial. Its objective is to evaluate the safety, tolerability, recommended dose, anti-tumor efficacy, and pharmacokinetic characteristics of CG-102-12C infused in participants with GPC3-positive advanced hepatocellular carcinoma who previously received adequate systemic standard treatments. The study will be carried out in accordance with the protocol. Due to the early-stage of the exploratory clinical research,, the anticipated sample size for the three dose groups is 7-12 participants.

Being tested
CG-102-12C
Keywords
Advanced Hepatocellular Carcinoma, Chimeric antigen receptor T Cell, GPC3

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CG-102-12CBiological

    Chimeric Antigen Receptor Autologous T-cell

Study groups in NCT07039201
Study groupRoleWhat they receive
Treatment groupExperimentalNot described
Receives: Biological: CG-102-12C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limiting toxicity (DLT)

    Describe the adverse events of limiting further increases in the dose of CG-102-12C

    Measured: Within 28 days of CG-102-12C infusion

  2. Treatment-emergent adverse events (TEAEs)

    Describe adverse events (AEs) and serious adverse events (SAEs) that are related to the study treatment during the treatment period.

    Measured: Within 24 months after the treatment

Secondary outcomes (8)

  1. Objective response rate (ORR)

    Objective response rate by RECIST 1.1.

    Measured: From treatment of the first subject to completion of follow-up of the last subject (up to 5 years)

  2. Disease control rate (DCR)

    The proportion of patients whose disease is controlled, which includes those who achieve a complete response (CR), partial response (PR), or stable disease (SD), out of the total number of evaluable patients.

    Measured: within 1 year after the last subject was treated

  3. Duration of remission (DOR)

    Duration of response by RECIST 1.1

    Measured: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)

  4. Time to remission (TTR)

    Time to remission by RECIST 1.1

    Measured: From enrollment of the first subject to completion of follow-up of the last subject (up to 3 years)

  5. Progression free survival (PFS)

    Progression-free survival by RECIST 1.1

    Measured: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)

  6. Overall survival (OS)

    Overall survival by RECIST 1.1.

    Measured: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)

  7. CAR-T Cmax

    Describe the peak concentration of CG-102-12C in vivo

    Measured: Within 28 days of CG-102-12C infusion

  8. CAR-T Tmax

    Describe the time from infusion to reaching peak concentration of CG-102-12C in vivo

    Measured: Within 28 days of CG-102-12C infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2025
  2. Study start28 Jun 2025
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07039201
Sponsor's protocol ID
CG-102-12C
Status last verified
Jan 2026
First submitted
22 Mar 2025
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CG-102-12C in people with Advanced Hepatocellular Carcinoma (HCC), run by Zhejiang University at 2 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 13 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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.

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 Qi Zhang, Professor (0571-87233418 ext. 086-1381913711, qi.zhang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicity (DLT) (time frame: Within 28 days of CG-102-12C 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?

On the ClinicalTrials.gov record for NCT07039201.

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 22 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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