Actively Recruiting
A Study to Evaluate C-CAR031 in Glypican-3 (GPC3)+ Advanced/Recurrent Hepatocellular Carcinoma (HCC)
Led by Shanghai AbelZeta Ltd. · Updated on 2026-01-02
121
Participants Needed
2
Research Sites
969 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This single-arm, open-label multicenter Phase I/II study will evaluate the safety, tolerability, anti-tumor activity, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of C-CAR031 in adult participants with GPC3+ advanced/recurrent HCC, who have progressed or are intolerant to at least two prior lines of standardized systemic therapy, and lack of other effective treatments.
CONDITIONS
Official Title
A Study to Evaluate C-CAR031 in Glypican-3 (GPC3)+ Advanced/Recurrent Hepatocellular Carcinoma (HCC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant voluntarily agrees and signs informed consent.
- Aged between 18 and 75 years at consent.
- Confirmed advanced HCC by tissue examination; no mixed HCC-cholangiocarcinoma.
- BCLC stage C or B (not suitable for surgery/local treatments) or China liver cancer stage II-III.
- Child-Pugh score 6 or less.
- GPC3-positive tumor confirmed by central lab using validated assay.
- Progressed or intolerant to at least two prior standardized systemic therapies.
- At least one measurable target lesion not previously treated locally or used for research biopsies.
- ECOG performance status of 0 or 1.
- Expected life expectancy of at least 12 weeks.
- Left ventricular ejection fraction 45% or higher within 28 days before apheresis.
- Blood tests within defined limits for neutrophils, lymphocytes, platelets, hemoglobin, bilirubin, liver enzymes, albumin, creatinine clearance, and coagulation.
- If Hepatitis B positive, must be on antiviral therapy with adequate viral suppression before infusion.
- Female participants of childbearing potential must test negative for pregnancy and agree to effective contraception for at least 12 months after infusion.
You will not qualify if you...
- Life-threatening allergies or intolerance to CAR-T product or its components.
- Allergies to lymphodepleting agents like fludarabine or cyclophosphamide.
- History of hepatic encephalopathy within 6 months or needing medications for it.
- Central nervous system diseases with neurological symptoms or recent strokes.
- Uncontrolled cardiac or lung diseases, recent heart attacks, or severe arrhythmias.
- History of organ transplant including liver.
- Prior CAR-T therapy or treatments targeting GPC3.
- Tumor occupying more than 50% of liver tissue.
- Main portal vein cancer embolus.
- Recent history of significant blood clots.
- Clinically meaningful ascites requiring intervention within 6 months.
- Uncontrolled pleural or pericardial effusion needing frequent drainage.
- Spinal cord compression, leptomeningeal disease, or brain metastases not stable or treated appropriately.
- Recent radiation or local cancer treatments within specified timeframes.
- Recent vaccination or blood transfusions near apheresis.
- Inadequate washout period from prior systemic treatments before apheresis.
- History of other cancers except certain cured low-risk types.
- Active or history of significant immunodeficiency diseases.
- Active Hepatitis C infection or co-infection with Hepatitis D.
- Active infections needing systemic treatment.
- Serious cardiac arrhythmias or heart failure class III or IV.
- Use of full-dose anticoagulants or bleeding risks.
- Pregnancy, lactation, or planning conception during the study.
- Any condition or therapy that could affect safety or study compliance as judged by investigator.
- Major surgery near study treatment or planned during study period.
- Unresolved significant toxicities from prior cancer treatments.
- Alcohol or drug abuse.
- HTLV infection positive.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
ZhongShan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
2
The First Affiliated Hospital, Zhejiang University School of Medicine
Hanzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
A
Andy Zou
CONTACT
N
Nicole Shen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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