Actively Recruiting
GPC3-CAR-T Cells for Immunotherapy of Cancer With GPC3 Expression
Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2024-06-25
30
Participants Needed
2
Research Sites
995 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital of Guangzhou Medical University
Lead Sponsor
H
Hunan Zhaotai Yongren Medical Innovation Co. Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The third/fourth generation of CAR-T cells that target GPC3 (GPC3-CART cell) and/or soluble TGFβ (GPC3/TGFβ-CART )have been constructed and their anti-HCC function has been verified by multiple in vitro and in vivo studies. Clinical studies will be performed to test the anti-cancer function by the GPC3/TGFβ-CAR-T cells in human HCC patients with GPC3 expression. In this phase I study, the safety, tolerance, and preliminary efficacy of the GPC3/TGFβ-CAR-T cell immunotherapy on human will firstly be tested.
CONDITIONS
Official Title
GPC3-CAR-T Cells for Immunotherapy of Cancer With GPC3 Expression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with advanced hepatocellular carcinoma expressing GPC3 protein
- Life expectancy longer than 12 weeks
- Child-Pugh-Turcotte score less than 7
- Adequate heart, lung, liver, and kidney function
- Availability of autologous transduced T cells with at least 20% GPC3 CAR expression and at least 20% killing of GPC3-positive targets in cytotoxicity tests
- Informed consent signed by patient or guardian
You will not qualify if you...
- Previous gene therapy treatment
- Tumor size larger than 25 cm
- Severe viral infections such as HBV, HCV, or HIV
- Known HIV positive status
- History of liver transplantation
- Active bacterial, viral, or fungal infections
- Other severe health conditions deemed inappropriate by investigators
- Pregnant or lactating women
- Systemic steroid use at or above 0.5 mg prednisone equivalent per kg per day
- Other conditions deemed inappropriate by investigators
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 of Sun Yat-sen University
Guangzhou, Guangdong, China, 510072
Actively Recruiting
2
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510260
Actively Recruiting
Research Team
Z
Zhenfeng Zhang, MD,PhD
CONTACT
P
Peng Li, PhD
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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