Actively Recruiting
Clinical Trial of Autologous GPC3 CAR-T Cells (CBG166) Therapy for Advanced Hepatocellular Carcinoma
Led by Zhejiang University · Updated on 2024-11-06
15
Participants Needed
2
Research Sites
173 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
C
Carbiogene Therapeutics Co. Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
A phase I clinical study of 4th generation chimeric antigen receptor T Cells targeting glypican-3 ( CAR-GPC3 T Cells) in patients with advanced hepatocellular carcinoma.
CONDITIONS
Official Title
Clinical Trial of Autologous GPC3 CAR-T Cells (CBG166) Therapy for Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 70 years, male or female
- Voluntarily signed informed consent
- Unresectable stage B or C hepatocellular carcinoma according to BCLC staging
- Disease progression after at least one prior systemic treatment
- Child-Pugh score of 7 or less
- At least one target intrahepatic lesion confirmed by imaging within 28 days before treatment
- Expected survival time greater than 12 weeks
- Glypican-3 expression confirmed by immunohistochemistry
- ECOG performance status score of 0 to 1
- Adequate organ function
- Negative hepatitis B surface antigen test; if positive for HBsAg or HBcAb, HBV-DNA must be less than 2000 IU/ml
- Negative pregnancy test for female subjects of childbearing age within 7 days before cell therapy
- Use of effective contraceptive measures during the study and for one year after CAR-T cell infusion for subjects of childbearing potential
You will not qualify if you...
- Resectable liver tumors or eligible for liver transplantation
- Pregnant or lactating women
- Active bacterial or fungal infections within 72 hours prior to gonorrhea clearance
- Systemic steroids greater than 15 mg/day prednisone equivalent within 2 weeks before apheresis (except recent or current inhaled steroids)
- Hemoglobin less than 80 g/L, absolute neutrophil count less than 1.0 x 10^9/L, or platelet count less than 60 x 10^9/L before apheresis
- Clinically significant ascites requiring intervention
- Liver tumor involvement of 50% or more, or tumor thrombus in main portal vein or certain veins
- Previous or current hepatic encephalopathy
- Active brain metastases
- History of or awaiting organ transplantation
- Positive for certain infections such as HBV DNA ≥ 2000 IU/mL, HCV RNA, HIV antibody, or positive syphilis test
- Serious medical conditions limiting study participation
- Anti-tumor therapy within 2 weeks before apheresis or investigational drug/systemic therapy within 28 days before consent
- Prior treatment targeting GPC3
- Unresolved toxicity from previous PD-1/PD-L1 therapy above grade 1, except hair loss or pigmentation
- Other untreated malignant tumors within past 5 years except in situ cervical cancer or basal cell skin carcinoma
- Inability or unwillingness to comply with study protocol
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
First Affiliated Hospital, Medical College of Zhejiang University
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
2
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
Q
Qi Zhang, Associate professor
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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