Actively Recruiting
An Open-Label, Phase I Clinical Trial of Super CAR-T With GPC3-Positive Advanced Hepatocellular Carcinoma
Led by Guangzhou FineImmune Biotechnology Co., LTD. · Updated on 2026-05-14
15
Participants Needed
1
Research Sites
122 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
This study was a phase I safety and tolerability clinical trial conducted in a single-center, open-label, 3+3 design with dose escalation.
CONDITIONS
Official 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 participating
- Age between 18 and 75 years
- Diagnosed with hepatocellular carcinoma (HCC) confirmed by histopathology or cytology
- Classified as inoperable Stage IIa, IIb, IIIa, or IIIb by CNLC or Stage C by BCLC, or Stage B but unsuitable for local treatment
- Child-Pugh liver function score of 7 or less
- Previous failure of or intolerance to at least two lines of standard systemic therapy
- Tumor sample or biopsy within 2 years testing positive for GPC3 by immunohistochemistry
- At least one measurable lesion per RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Expected survival longer than 3 months
- Echocardiography showing left ventricular ejection fraction (LVEF) of 50% or higher
- Laboratory values meeting specified thresholds for ANC, platelets, hemoglobin, creatinine clearance, AST, ALT, and total bilirubin
- HBV-DNA level of 2000 IU/mL or less if HBsAg-positive or HBcAb-positive
- 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 during the trial
- Allergy to study drugs including cyclophosphamide, fludarabine, CAR-T products, or excipients
- Unrecovered adverse reactions from prior surgery or treatment above Grade 2, except alopecia or hyperpigmentation
- Significant central nervous system disorders or neurological symptoms
- Radiotherapy, systemic chemotherapy, or immune checkpoint inhibitors within 2 weeks before apheresis
- Targeted therapies like sorafenib, regorafenib, or lenvatinib within 1 week before apheresis
- Systemic glucocorticoid therapy within 7 days before plasma donation, excluding inhaled or topical use and physiological-dose replacement
- Uncontrolled active infections including tuberculosis
- Active autoimmune diseases except vitiligo
- History of organ transplantation, stem cell transplantation, or renal replacement therapy
- Positive for HCV with detectable RNA, HIV antibody-positive, or syphilis antibody-positive
- Pregnant, breastfeeding, or planning pregnancy during the study
- Unable or unwilling to comply with study protocol requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Gaungdong, China, 510700
Actively Recruiting
Research Team
Y
YING CHENG
CONTACT
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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