Hepatocellular Carcinoma (HCC)Early Phase 1NCT07487402
Safety and Efficacy of Metabolically Armed GPC3 CAR-T Cells Injection (Meta10-GPC3) in Patients With Unresectable Recurrent/Metastatic Hepatocellular Carcinoma
A Early Phase 1 study testing Metabolically Armed GPC3 CAR-T cells in people with Hepatocellular Carcinoma (HCC), run by Zhejiang University at 1 site in China.
Trial summary
A Study of Metabolically Armed GPC3 CAR-T Cells Injection (Meta10-GPC3) in Patients with Unresectable Recurrent/Metastatic Hepatocellular Carcinoma. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Metabolically Armed GPC3 CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2026to 15 Apr 2029
- Phase
- Early Phase 1
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years and ≤75 years, male or female.
- Histologically confirmed recurrent or metastatic hepatocellular carcinoma (HCC) that is not amenable to surgical resection.
- At least one measurable target lesion according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
- Tumor tissue must test positive for GPC3 expression by immunohistochemical (IHC), defined as > 25% of tumor cells staining for GPC3 in the pathological specimen. Preferably, the target lesion sample should be used, including freshly obtained tumor tissue or archival tissue samples deemed acceptable by the investigator.
- Expected survival ≥ 12 weeks.
- Child-Pugh class A.
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- Eastern Cooperative Oncology Group (ECOG) performance status was 0-1.
- For subjects who are HBsAg or HBcAb positive, HBV-DNA must be < 2 000 IU/mL; HBsAg-positive patients must receive antiviral therapy according to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition).
- Adequate venous access for leukapheresis or venous blood collection.
- Hematologic parameters: WBC ≥ 2.5 × 10⁹/L, platelets ≥ 60 × 10⁹/L, Hb ≥ 9.0 g/dL, lymphocytes ≥ 0.4 × 10⁹/L.
- Biochemical parameters: Serum albumin ≥ 30 g/L; Lipase and amylase ≤ 1.5 × ULN; serum creatinine ≤ 1.5 × ULN and estimated creatinine clearance ≥ 40 mL/min; ALT and AST ≤ 5 × ULN; serum total bilirubin ≤ 2.5 × ULN; prothrombin time ≤ 4s longer above normal.
- Women or childbearing potential must have a negative serum pregnancy test within 14 days before CAR-T cell infusion and agree to use effective contraception for 12 months after infusion. Male subjects with partners of childbearing potential must having undergone a vasectomy or agree to use reliable contraception during the study period.
- Ability to understand and sign the informed consent form.
Who cannot join
- Pregnant or breastfeeding women, or women of childbearing potential who test positive on a pregnancy test during the screening period).
- Active hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection; seropositivity for Human Immunodeficiency (HIV) or syphilis.
- Any uncontrolled active infection, including but not limited to active pulmonary tuberculosis.
- Therapeutic doses of corticosteroids must be discontinued at least 2 weeks prior to Meta10-GPC3 infusion; any immunosuppressive medications must be discontinued at least 4 weeks before signing the informed consent form.
- History of hypersensitivity to immunotherapy or related agents, β-lactam antibiotics, or other severe allergic reactions.
- History or presence of hepatic encephalopathy.
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- Clinically significant ascites, defined as ascites detectable on physical examination or requiring therapeutic intervention (excluding ascites detected only by imaging that does not require intervention).
- Imaging showing that HCC occupies ≥ 50 % of normal liver volume, or presence of tumor thrombus in the main portal vein or inferior vena cava.
- Clinically significant central-nervous-system (CNS) disorders (excluding subjects with CNS HCC metastases).
- Active or decompensated cardiac illness (requiring hospitalization or surgical intervention within the past 6 months), or poorly pression ≥ 160/100 mmHg uncontrolled with medication. Stable coronary artery disease or well-controlled hypertension is allowed.
- Active autoimmune disease requiring immunosuppressive therapy.
- Prior organ transplantation or currently on an organ transplant waiting list (including but not limited to liver transplantation).
- Any anti-HCC therapy within 2 weeks prior to leukapheresis or blood collection, including but not limited to surgical resection, interventional therapy, radiotherapy, chemotherapy, or immunotherapy.
- History or concurrent presence of other malignancies, except for the following: surgically removed non-melanoma skin cancer, cured cervical carcinoma in situ, localized prostate cancer, low-stage bladder cancer, ductal carcinoma in situ of the breast, or any malignancy without recurrence or treatment within the past 2 years.
- Other severe medical conditions, including but not limit to: poorly controlled diabetes (post-treatment HbA1c > 7 %), severe cardiac dysfunction (LVEF < 45 %), myocardial infarction, unstable angina, or unstable arrhythmia within 6 months, pulmonary embolism, chronic obstructive pulmonary disease, interstitial lung disease, forced expiratory volume in 1 second (FEV1) < 60 %, gastric ulcer, history of gastrointestinal bleeding, documented bleeding diathesis, uncontrolled thrombotic events, major bleeding, or DVT within 12 months prior to informed consent.
- Active neurological autoimmune or inflammatory disorders (e.g., Guillain-Barré syndrome, amyotrophic lateral sclerosis).
- History of QT-interval prolongation or severe cardiac disease.
- Any other condition deemed by the investigator to make the subject unsuitable for participation in the study (e.g., poor compliance).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, 310000
Qihan Fu, 18268173309, ayfuqihan@126.com
About this study
A Study of Metabolically Armed GPC3 CAR-T Cells Injection (Meta10-GPC3) in Patients with Unresectable Recurrent/Metastatic Hepatocellular Carcinoma.
Read the detailed description
This is an open-label study. This study is indicated for unresectable recurrent/metastatic hepatocellular carcinoma.The selections of dose levels and the number of subjects are based on clinical trials of similar products and the outcomes of our preliminary clinical studies.
- Main research objectives: To evaluate the safety and tolerability of metabolically armed GPC3 CAR-T cells injection (Meta10-GPC3) in patients with unresectable recurrent/metastatic hepatocellular carcinoma.
- Secondary research objectives: (1)To evaluate the efficacy of metabolically armed GPC3 CAR-T-cell therapy in unresectable recurrent/metastatic hepatocellular carcinoma. (2) To assess the in vivo pharmacokinetic (PK) profile, phenotype, and functional activity of infused GPC3 CAR-T cells.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Metabolically Armed GPC3 CAR-T cells
- Keywords
- Meta10-GPC3, unresectable recurrent/metastatic hepatocellular carcinoma, IL-10
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolically Armed GPC3 CAR-T cellsDrug
Also called Meta10-GPC3
Each subject receive metabolically armed GPC3 CAR- T cells by intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Administration of Metabolically Armed GPC3 CAR-T Therapy | Experimental | Patients undergo peripheral blood collection. Patients will receive a lymphodepletion chemotherapy with cyclophosphamide and fludarabine before CAR-T cells infusion.
The study will design metabolically armed GPC3 CAR-T cells(Meta10-GPC3) with different structures. A dose of Meta10-GPC3 CAR-T cells will be infused on day 0. Receives: Drug: Metabolically Armed GPC3 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
To characterize the safety profile of Meta10-GPC3 in patients with unresectable recurrent/metastatic hepatocellular carcinoma as assessed by incidence of adverse events. Adverse events will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Measured: Within 2 years post Meta10-GPC3 infusion.
Secondary outcomes (7)
Objective response rate (ORR)
To evaluate the proportion of participants who have a confirmed partial response (PR) and complete response (CR) per RECIST v1.1 as assessed by the investigator.
Measured: 12 week, 20 week, 28 week, 40 week, 52 week, 78 week, 104 week post Meta10-GPC3 infusion.
Duration of Response (DOR)
To evaluate the duration from the time that criteria are met for CR or PR per RECIST v1.1 as assessed by the investigator until disease progression or death due to any cause.
Measured: 12 week, 20 week, 28 week, 40 week, 52 week, 78 week, 104 week post Meta10-GPC3 infusion.
Progression-free survival (PFS)
The time from the start of Meta10-GPC3 treatment for the subjects to the first disease progression or death for any reason.
Measured: 12 week, 20 week, 28 week, 40 week, 52 week, 78 week, 104 week post Meta10-GPC3 infusion.
Overall survival (OS)
OS is measured from the date of the infusion of Meta10-GPC3 to the date of the subjects' death.
Measured: 12 week, 20 week, 28 week, 40 week, 52 week, 78 week, 104 week post Meta10-GPC3 infusion
The maximum concentration (Cmax)
The Cmax of CAR-T cell expansion in peripheral blood
Measured: Within 2 years post Meta10-GPC3 infusion.
Tmax
The time to reach the maximum concentration (Tmax)
Measured: Within 2 years post Meta10-GPC3 infusion.
AUC1-30d
The area under the curve AUC0-28d at 28 days.
Measured: Within 1 month post Meta10-GPC3 infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start30 Mar 2026 (estimated)
- Primary completion15 Dec 2028 (estimated)
- Study completion15 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Leman Biotech Co., Ltd.
- Responsible party
- Principal investigator, TingBo Liang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487402
- Sponsor's protocol ID
- LM-META10-GPC3-13
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Metabolically Armed GPC3 CAR-T Cells Injection (Meta10-GPC3) in Patients With Unresectable Recurrent/Metastatic Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07487402
- Acronym / sponsor ID
- LM-META10-GPC3-13
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- Meta10-GPC3, unresectable recurrent/metastatic hepatocellular carcinoma, IL-10
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Leman Biotech Co., Ltd.
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 15 Dec 2028 (estimated)
- Study completion
- 15 Apr 2029 (estimated)
- First posted
- 23 Mar 2026 (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.
A Study of Metabolically Armed GPC3 CAR-T Cells Injection (Meta10-GPC3) in Patients with Unresectable Recurrent/Metastatic Hepatocellular Carcinoma.
Detailed description
This is an open-label study. This study is indicated for unresectable recurrent/metastatic hepatocellular carcinoma.The selections of dose levels and the number of subjects are based on clinical trials of similar products and the outcomes of our preliminary clinical studies.
- Main research objectives: To evaluate the safety and tolerability of metabolically armed GPC3 CAR-T cells injection (Meta10-GPC3) in patients with unresectable recurrent/metastatic hepatocellular carcinoma.
- Secondary research objectives: (1)To evaluate the efficacy of metabolically armed GPC3 CAR-T-cell therapy in unresectable recurrent/metastatic hepatocellular carcinoma. (2) To assess the in vivo pharmacokinetic (PK) profile, phenotype, and functional activity of infused GPC3 CAR-T cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Administration of Metabolically Armed GPC3 CAR-T Therapy | Experimental | Drug: Metabolically Armed GPC3 CAR-T cellsPatients undergo peripheral blood collection. Patients will receive a lymphodepletion chemotherapy with cyclophosphamide and fludarabine before CAR-T cells infusion. The study will design metabolically armed GPC3 CAR-T cells(Meta10-GPC3) with different structures. A dose of Meta10-GPC3 CAR-T cells will be infused on day 0. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age >18 years and ≤75 years, male or female.
- Histologically confirmed recurrent or metastatic hepatocellular carcinoma (HCC) that is not amenable to surgical resection.
- At least one measurable target lesion according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
- Tumor tissue must test positive for GPC3 expression by immunohistochemical (IHC), defined as > 25% of tumor cells staining for GPC3 in the pathological specimen. Preferably, the target lesion sample should be used, including freshly obtained tumor tissue or archival tissue samples deemed acceptable by the investigator.
- Expected survival ≥ 12 weeks.
Key exclusion criteria (18 listed)
- Pregnant or breastfeeding women, or women of childbearing potential who test positive on a pregnancy test during the screening period).
- Active hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection; seropositivity for Human Immunodeficiency (HIV) or syphilis.
- Any uncontrolled active infection, including but not limited to active pulmonary tuberculosis.
- Therapeutic doses of corticosteroids must be discontinued at least 2 weeks prior to Meta10-GPC3 infusion; any immunosuppressive medications must be discontinued at least 4 weeks before signing the informed consent form.
- History of hypersensitivity to immunotherapy or related agents, β-lactam antibiotics, or other severe allergic reactions.
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 |
|---|---|---|
| Metabolically Armed GPC3 CAR-T cellsAlso: Meta10-GPC3Each subject receive metabolically armed GPC3 CAR- T cells by intravenous infusion. | Drug | Administration of Metabolically Armed GPC3 CAR-T Therapy |
Primary outcome
Adverse Events (AEs)
Time frame: Within 2 years post Meta10-GPC3 infusion.
To characterize the safety profile of Meta10-GPC3 in patients with unresectable recurrent/metastatic hepatocellular carcinoma as assessed by incidence of adverse events. Adverse events will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
7 secondary outcomes
Objective response rate (ORR)
Time frame: 12 week, 20 week, 28 week, 40 week, 52 week, 78 week, 104 week post Meta10-GPC3 infusion.
Duration of Response (DOR)
Time frame: 12 week, 20 week, 28 week, 40 week, 52 week, 78 week, 104 week post Meta10-GPC3 infusion.
Progression-free survival (PFS)
Time frame: 12 week, 20 week, 28 week, 40 week, 52 week, 78 week, 104 week post Meta10-GPC3 infusion.
Overall survival (OS)
Time frame: 12 week, 20 week, 28 week, 40 week, 52 week, 78 week, 104 week post Meta10-GPC3 infusion
The maximum concentration (Cmax)
Time frame: Within 2 years post Meta10-GPC3 infusion.
Tmax
Time frame: Within 2 years post Meta10-GPC3 infusion.
AUC1-30d
Time frame: Within 1 month post Meta10-GPC3 infusion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Metabolically Armed GPC3 CAR-T cells in people with Hepatocellular Carcinoma (HCC), run by Zhejiang University at 1 site 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 18 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: opening soon, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Qihan Fu (18268173309, ayfuqihan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AEs) (time frame: Within 2 years post Meta10-GPC3 infusion.). 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 21 Apr 2026.