Actively Recruiting
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
Led by Guangzhou FineImmune Biotechnology Co., LTD. · Updated on 2026-05-14
15
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
G
Guangzhou FineImmune Biotechnology Co., LTD.
Lead Sponsor
S
Sun Yat-Sen University Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a phase I clinical trial to evaluate the safety and tolerability of a treatment called Super CAR-T in patients with advanced hepatocellular carcinoma (HCC) that tests positive for GPC3. This open-label, single-center study uses a 3+3 dose escalation design to find the appropriate dose. The trial focuses on patients with inoperable or advanced HCC who have previously failed or cannot tolerate standard therapies. Participants receive lymphodepleting preconditioning followed by a single infusion of Super CAR-T cells, which are designed to target GPC3-positive tumor cells. The dose of Super CAR-T cells is gradually increased across three levels to monitor toxicity. The trial includes screening to confirm GPC3 positivity in tumor tissue before treatment. During the study, participants will be monitored closely for dose-limiting toxicities and maximum tolerated dose within 28 days after infusion. Researchers will also assess tumor response, progression-free survival, and overall survival up to one year after treatment. Various tests including echocardiography, laboratory studies, and performance status evaluations are performed to ensure safety and track outcomes throughout the trial.
CONDITIONS
Brief Title
An Open-Label, Phase I Clinical Trial of Super CAR-T With GPC3-Positive Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily sign the informed consent form prior to any trial activities
- Be between 18 and 75 years of age
- Diagnosed with hepatocellular carcinoma (HCC) confirmed by pathology or cytology
- Classified as inoperable Stage IIa, IIb, IIIa, or IIIb (CNLC system), or Stage C (BCLC system), or Stage B inoperable or unsuitable for local treatment
- Child-Pugh liver function score of 7 or less
- Previous failure or intolerance to at least two lines of standard systemic therapy
- Provide a tumor or biopsy sample collected within 2 years that tests positive for GPC3 via immunohistochemistry
- Have at least one measurable lesion per RECIST 1.1 criteria
- ECOG performance status of 0-1
- Expected survival longer than 3 months
- Left ventricular ejection fraction (LVEF) of 50% or greater by echocardiography
- Laboratory tests meeting specified thresholds for ANC, platelets, hemoglobin, creatinine clearance, AST, ALT, and total bilirubin
- If hepatitis B surface or core antibody positive, HBV-DNA must be 2000 IU/mL or less
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during treatment
You will not qualify if you...
- Major surgery within 2 weeks before apheresis or planned major surgery during the trial
- Allergy to any study drug components including cyclophosphamide, fludarabine, or CAR-T products
- Unresolved prior surgery or treatment adverse reactions above Grade 2, except alopecia and hyperpigmentation
- Clinically significant central nervous system disorders or neurological symptoms
- Radiotherapy, systemic chemotherapy, or immune checkpoint inhibitors within 2 weeks before apheresis
- Targeted small molecule therapies within 1 week before apheresis
- Systemic glucocorticoid therapy within 7 days before plasma donation, though inhaled or topical steroids and replacement therapy are allowed
- Uncontrolled active infections including tuberculosis
- Known active autoimmune diseases except vitiligo
- History of organ or stem cell transplantation or renal replacement therapy
- Positive for HCV RNA above detection limit, HIV, or syphilis antibodies
- Currently pregnant, breastfeeding, or planning pregnancy during the study
- Inability or unwillingness to comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 28 days after cell infusion
Participants receive lymphoid-depleting preconditioning followed by a single infusion of Super CAR-T cells.
1 preconditioning visit and 1 infusion visit, with follow-up assessments until Day 28
Duration - Up to 1 year after cell infusion
Participants are monitored for treatment response and survival outcomes after the infusion.
Periodic visits during the one-year follow-up period
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Gaungdong, China, 510700
Actively Recruiting
Research Team
Y
YING CHENG
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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