Supercharged immune cells take on advanced liver cancer
NCT ID NCT07493044
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial is testing a new treatment called Super CAR-T for people with advanced hepatocellular carcinoma, a type of liver cancer that has spread. The treatment involves taking a patient's own immune cells, modifying them to better recognize and attack cancer cells, and infusing them back. The main goals are to find a safe dose and check for any serious side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Super CAR-T cells (a type of immune cell therapy)
- What this could lead to
- If it works, this could point toward a new treatment option for advanced liver cancer that is hard to treat.
- What could go wrong
- This is a very early, small phase 1 trial with only 15 people, so safety and effectiveness are not yet proven. There may be serious side effects from the immune cells or the pre-treatment chemotherapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Understand and voluntarily sign the informed consent form prior to participating in any trial-related activities; 2. Be between 18 and 75 years of age; gender is not restricted; 3. 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; 4. Previous failure of or intolerance to at least two lines of standard systemic therapy; 5. 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; 6. At least one measurable lesion according to RECIST 1.1 criteria; 7. ECOG performance status of 0-1; 8. Expected survival of more than 3 months; 9. Echocardiography showing a left ventricular ejection fraction (LVEF) ≥50%; 10. 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; 11. If HBsAg-positive or HBcAb-positive, HBV-DNA must be ≤ 2000 IU/mL; 12. Women of childbearing potential must have a negative pregnancy test prior to receiving study treatment; they must agree to use effective contraception during treatment. Exclusion Criteria: 1. The subject has undergone major surgery within 2 weeks prior to apheresis, or is expected to undergo major surgery during the trial; 2. 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; 3. 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; 4. 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); 5. 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; 6. 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; 7. Any uncontrolled active infection, including but not limited to active tuberculosis or infectious diseases requiring systemic treatment; 8. 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); 9. History of organ transplantation, autologous/allogeneic stem cell transplantation, or renal replacement therapy; 10. HCV antibody-positive with HCV RNA levels above the lower limit of detection; HIV antibody-positive; syphilis antibody-positive; 11. Currently pregnant or breastfeeding, or planning to become pregnant during the study; 12. Participants deemed by the investigator to be unable or unwilling to comply with the requirements of the study protocol.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Gaungdong, 510700, China
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Other studies related to the condition(s) this trial covers.
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- New immunotherapy combo takes on advanced liver cancer