Advanced Hepatocellular Carcinoma (HCC)Phase 1NCT07493044
An Open-Label, Phase I Clinical Trial of Super CAR-T With GPC3-Positive Advanced Hepatocellular Carcinoma
A Phase 1 study testing Super CAR-T in people with Advanced Hepatocellular Carcinoma (HCC) and GPC3 Positive Hepatocellular Carcinoma, run by Guangzhou FineImmune Biotechnology Co., LTD. at 1 site in China.
Trial summary
This study was a phase I safety and tolerability clinical trial conducted in a single-center, open-label, 3+3 design with dose escalation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Hepatocellular Carcinoma (HCC), GPC3 Positive Hepatocellular Carcinoma
- What is being tested?
- Super CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2026to 30 Jul 2028
- Phase
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand and voluntarily sign the informed consent form prior to participating in any trial-related activities;
- Be between 18 and 75 years of age; gender is not restricted;
- Diagnosed with hepatocellular carcinoma (HCC) based on histopathological or cytological examination: Patients classified as inoperable Stage IIa, IIb, IIIa, or IIIb according to the Chinese National Liver Cancer (CNLC) staging system, or Stage C according to the Barcelona Clinic Liver Cancer (BCLC) staging system, or Stage B patients who are inoperable or unsuitable for local treatment; Child-Pugh liver function score ≤ 7;
- Previous failure of or intolerance to at least two lines of standard systemic therapy;
- The subject must provide a tumor sample or biopsy specimen collected within the past 2 years that meets the requirements and tests positive for GPC3 expression via immunohistochemistry;
- At least one measurable lesion according to RECIST 1.1 criteria;
Show all 13Show fewer
- ECOG performance status of 0-1;
- Expected survival of more than 3 months;
- Echocardiography showing a left ventricular ejection fraction (LVEF) ≥50%;
- Laboratory test results must meet at least the following criteria:
- ANC ≥1.0×10⁹/L; PLT ≥75×10⁹/L; Hb ≥ 75 g/L; Creatinine clearance ≥ 60 mL/min; AST ≤ 5×ULN; ALT≤ 5×ULN; TBIL ≤ 3×ULN;
- If HBsAg-positive or HBcAb-positive, HBV-DNA must be ≤ 2000 IU/mL;
- Women of childbearing potential must have a negative pregnancy test prior to receiving study treatment; they must agree to use effective contraception during treatment.
Who cannot join
- The subject has undergone major surgery within 2 weeks prior to apheresis, or is expected to undergo major surgery during the trial;
- The subject is allergic to any component of the drugs to be used in this study, including but not limited to cyclophosphamide, fludarabine, CAR-T products, or their excipients;
- Has not recovered from adverse reactions related to prior surgery or treatment to Grade ≤ 2; exceptions include alopecia, hyperpigmentation, and other conditions deemed by the investigator not to affect the subject's tolerability;
- Has a clinically significant central nervous system (CNS) disorder (e.g., epilepsy, severe cerebrovascular stenosis) or other diseases presenting with significant neurological symptoms (including psychiatric disorders);
- Received radiotherapy, systemic chemotherapy, or immune checkpoint inhibitors for the study disease within 2 weeks prior to apheresis; or received small-molecule targeted therapies such as sorafenib, regorafenib, or lenvatinib within 1 week prior to apheresis;
- Received systemic glucocorticoid therapy within 7 days prior to single-plasma donation; patients currently using or who have recently used inhaled or topical glucocorticoids, as well as those on physiological-dose replacement therapy, are eligible for enrollment;
Show all 12Show fewer
- Any uncontrolled active infection, including but not limited to active tuberculosis or infectious diseases requiring systemic treatment;
- Known active autoimmune diseases, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, autoimmune hepatitis, multiple sclerosis, and glomerulonephritis (patients with vitiligo are not excluded);
- History of organ transplantation, autologous/allogeneic stem cell transplantation, or renal replacement therapy;
- HCV antibody-positive with HCV RNA levels above the lower limit of detection; HIV antibody-positive; syphilis antibody-positive;
- Currently pregnant or breastfeeding, or planning to become pregnant during the study;
- Participants deemed by the investigator to be unable or unwilling to comply with the requirements of the study protocol.
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, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Gaungdong, 510700
BINKUI LI, Professor, 86-02087343114, libk@sysucc.org.cn
About this study
Official title: An Open-Label, Phase I Clinical Trial of GPC3-Targeted Chimeric Antigen Receptor Autologous T-Cell Injection (Super CAR-T) for the Treatment of Patients With Advanced Hepatocellular Carcinoma
This study was a phase I safety and tolerability clinical trial conducted in a single-center, open-label, 3+3 design with dose escalation.
Read the detailed description
After the subjects signed the informed consent form,the tumor tissue was detected by immunohistochemistry. The subjects could proceed to the subsequent clinical trial if the GPC3 immunohistochemistry was positive. Each subject received only one cell infusion.
- Being tested
- Super CAR-T
- Keywords
- GPC3 CAR-T, Cell therapy, Immunotherapy, Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super CAR-TBiological
All participators received lymphoid-depleted preconditioning before Super CAR-T cells infusion.
Super CAR-T cells were infused 3 days later.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation was performed in a 3+3 design | Experimental | The Super CAR-T dose toxicity test was escalated according to the following dose (positive cells) escalation schedule: Level 1 Level 2 Level 3 Receives: Biological: Super CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT)
Determining the DLT of Super CAR-T adoptive Immunotherapy.
Measured: 28 days after cell infusion
Maximum Tolerated Dose (MTD)
Determining the MTD of Super CAR-T adoptive Immunotherapy.
Measured: 28 days after cell infusion
Secondary outcomes (3)
Objective Response Rate(ORR)
ORR defined as the proportion of subjects with a confirmed PR or better best response.
Measured: Research period
Progression Free Survival(PFS)
PFS defined the time from the subject's treatment to the occurrence of PD or death from any cause, whichever occurred first. If no event (PD or death) occurred, the date of the last response assessment was the censored time for PFS.
Measured: One year after cell infusion
Overall Survival (OS)
OS defined time from subject's treatment to death. Participants with no death recorded at the time of statistical analysis were censored at the time of the last follow-up. In cases of loss to follow-up, data were censored at the date of the last contact with the participant.
Measured: One year after cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start27 Mar 2026
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou FineImmune Biotechnology Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sun Yat-Sen University Cancer Center
- Responsible party
- Sponsor
- Investigators
- BINKUI LI, Professor, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493044
- Sponsor's protocol ID
- FIT004-IIT
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data is subject to the company's confidentiality requirements and therefore cannot be disclosed.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase I Clinical Trial of GPC3-Targeted Chimeric Antigen Receptor Autologous T-Cell Injection (Super CAR-T) for the Treatment of Patients With Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07493044
- Acronym / sponsor ID
- FIT004-IIT
- Keywords
- GPC3 CAR-T, Cell therapy, Immunotherapy, Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Guangzhou FineImmune Biotechnology Co., LTD.Industry (pharma, biotech, devices)
- Collaborators
- Sun Yat-Sen University Cancer Center
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 25 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.
This study was a phase I safety and tolerability clinical trial conducted in a single-center, open-label, 3+3 design with dose escalation.
Detailed description
After the subjects signed the informed consent form,the tumor tissue was detected by immunohistochemistry. The subjects could proceed to the subsequent clinical trial if the GPC3 immunohistochemistry was positive. Each subject received only one cell infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose escalation was performed in a 3+3 design | Experimental | Biological: Super CAR-TThe Super CAR-T dose toxicity test was escalated according to the following dose (positive cells) escalation schedule: Level 1 Level 2 Level 3 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Understand and voluntarily sign the informed consent form prior to participating in any trial-related activities;
- Be between 18 and 75 years of age; gender is not restricted;
- Diagnosed with hepatocellular carcinoma (HCC) based on histopathological or cytological examination: Patients classified as inoperable Stage IIa, IIb, IIIa, or IIIb according to the Chinese National Liver Cancer (CNLC) staging system, or Stage C according to the Barcelona Clinic Liver Cancer (BCLC) staging system, or Stage B patients who are inoperable or unsuitable for local treatment; Child-Pugh liver function score ≤ 7;
- Previous failure of or intolerance to at least two lines of standard systemic therapy;
- The subject must provide a tumor sample or biopsy specimen collected within the past 2 years that meets the requirements and tests positive for GPC3 expression via immunohistochemistry;
Key exclusion criteria (12 listed)
- The subject has undergone major surgery within 2 weeks prior to apheresis, or is expected to undergo major surgery during the trial;
- The subject is allergic to any component of the drugs to be used in this study, including but not limited to cyclophosphamide, fludarabine, CAR-T products, or their excipients;
- Has not recovered from adverse reactions related to prior surgery or treatment to Grade ≤ 2; exceptions include alopecia, hyperpigmentation, and other conditions deemed by the investigator not to affect the subject's tolerability;
- Has a clinically significant central nervous system (CNS) disorder (e.g., epilepsy, severe cerebrovascular stenosis) or other diseases presenting with significant neurological symptoms (including psychiatric disorders);
- Received radiotherapy, systemic chemotherapy, or immune checkpoint inhibitors for the study disease within 2 weeks prior to apheresis; or received small-molecule targeted therapies such as sorafenib, regorafenib, or lenvatinib within 1 week prior to apheresis;
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 |
|---|---|---|
| Super CAR-TAll participators received lymphoid-depleted preconditioning before Super CAR-T cells infusion. Super CAR-T cells were infused 3 days later. | Biological | Dose escalation was performed in a 3+3 design |
Primary outcome
Dose Limiting Toxicity (DLT)
Time frame: 28 days after cell infusion
Determining the DLT of Super CAR-T adoptive Immunotherapy.
Maximum Tolerated Dose (MTD)
Time frame: 28 days after cell infusion
Determining the MTD of Super CAR-T adoptive Immunotherapy.
3 secondary outcomes
Objective Response Rate(ORR)
Time frame: Research period
Progression Free Survival(PFS)
Time frame: One year after cell infusion
Overall Survival (OS)
Time frame: One year after cell 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 14 May 2026.
- Individual participant dataSharing planned: No. The data is subject to the company's confidentiality requirements and therefore cannot be disclosed.
Related trials for Advanced Hepatocellular Carcinoma (HCC)
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Not yet recruitingPhase 2
A Clinical Study Evaluating the Safety and Efficacy of Ivonescimab as Second-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Hepatocellular Carcinoma (HCC), HCC - Hepatocellular Carcinoma
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Hepatocellular Carcinoma (HCC), Metastatic Uveal Melanoma
Not yet recruitingPhase 2
Study Evaluating the Efficacy and Safety of BGB-B2033 in Participants With Advanced Hepatocellular Carcinoma
Hepatocellular Cancer, Liver Cancer
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.
BINKUI LI, Professor principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Super CAR-T in people with Advanced Hepatocellular Carcinoma (HCC) and GPC3 Positive Hepatocellular Carcinoma, run by Guangzhou FineImmune Biotechnology Co., LTD. 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 12 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 14 May 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 YING CHENG (86-02031605836, chengy02@fineimmu.com), 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: 28 days after cell 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?
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 14 May 2026.