Actively Recruiting
A Study to Evaluate CG-102-12C in Glypican-3 (GPC3) Positive Advanced Hepatocellular Carcinoma (HCC)
Led by Zhejiang University · Updated on 2026-01-22
12
Participants Needed
2
Research Sites
109 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
C
Cells & Genes Biotech
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a single-centre, single-arm, open-label, dose-escalation exploratory study with single-dose administration. Its objective is to evaluate the safety, tolerability, dose, anti-tumor efficacy, and pharmacokinetic characteristics of CG-102-12C in the participants with GPC3-positive advanced hepatocellular carcinoma who previously received adequate but uneffective systemic standard treatments.
CONDITIONS
Official Title
A Study to Evaluate CG-102-12C in Glypican-3 (GPC3) Positive Advanced Hepatocellular Carcinoma (HCC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent after understanding study risks and benefits
- Aged 18 to 75 years inclusive
- Advanced hepatocellular carcinoma confirmed GPC3-positive by tissue analysis
- Advanced HCC defined as BCLC stage C or stage B unsuitable for or progressed after local treatment
- Previous systemic standard treatment with treatment failure or intolerance
- GPC3 positivity in tumor tissue (over 25% cells positive with staining intensity ≥1+)
- Child-Pugh score of 7 or less
- At least one measurable tumor lesion by RECIST 1.1
- ECOG performance status score of 0 to 2
- Expected survival of at least 3 months
- Hematological parameters: ANC ≥1×10^9/L; ALC ≥0.5×10^9/L; Platelets ≥50×10^9/L; Hemoglobin ≥60 g/L or hematocrit >0.24
- Blood biochemistry within specific limits: TBIL ≤2.5× ULN; AST and ALT ≤5× ULN; Albumin ≥28 g/L; Creatinine ≤1.5× ULN; Creatinine clearance >50 mL/min
- Coagulation parameters: INR <1.5× ULN; APTT <1.5× ULN; PT prolongation ≤4 seconds
- HBV-DNA ≤2000 IU/mL if HBsAg or HBcAb positive
- Negative pregnancy test for women of childbearing potential at screening, apheresis, and preconditioning
- Use of effective contraception during study and for 1 year after treatment completion
You will not qualify if you...
- History of second primary malignancy within the past 5 years, except certain treated cancers
- Prior treatment with CAR-T, TCR-T targeting any antigen, or therapies targeting GPC3
- Recent antitumor therapies within specified washout periods prior to apheresis
- Unresolved toxicities from prior treatments above grade 1 except specified exceptions
- History of or awaiting organ transplantation
- Brain metastases with CNS symptoms or other significant CNS diseases
- History or current hepatic encephalopathy
- Ascites requiring treatment
- Tumor volume ≥50% of normal liver volume or tumor thrombus in major vessels
- Pregnant or breastfeeding women
- Positive for HCV antibody or HIV antibody; active syphilis
- Severe active infections, unstable autoimmune diseases, uncontrolled diabetes, severe heart conditions, uncontrolled hypertension, significant arrhythmias, dementia or psychiatric disorders
- Recent stroke or seizure within 6 months
- Significant bleeding disorders
- Systemic corticosteroid or immunosuppressive therapy within 7 days prior to apheresis, except certain uses
- Live vaccines within 4 weeks prior to apheresis
- Major surgery within 2 weeks prior to apheresis or planned surgery during study (local anesthesia surgery allowed)
- History of severe allergic reactions or hypersensitivity to study drugs
- Any condition judged by investigator as unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
2
First Affiliated Hospital, Medical College of Zhejiang University
Hangzhou, Zhejiang, China, 310003
Not Yet Recruiting
Research Team
Q
Qi Zhang, Professor
CONTACT
F
Fan Yang
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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