The goal of this clinical trial is to evaluate the safety and efficacy of anti-GPC3 scFv-41BB-CD3ζ-tEGFR chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating patients with GPC3-positive advanced hepatocellular carcinoma (HCC).
Primary Objectives: 1. To evaluate the safety of intravenous administration of the anti-GPC3 CAR-T cells in patients with HCC or lung squamous cell carcinoma 2. To access the safety of anti-GPC3 CAR-T cells in HCC patients through catheter injection Secondary Objectives: 1. To evaluate the efficacy of anti-GPC3 CAR-T cells in patients with advanced HCC or lung squamous cell carcinoma 2. To monitor the serum cytokine and expression level of tumor markers such as AFP, CEA and GPC3 3. To assess the persistence in peripheral blood and intratumoral infiltration of anti-GPC3 CAR-T cells
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
transcatheter arterial chemoembolization + CAR-T infusion
Fludarabine will be administered at dose of 25mg/m2/d
Cyclophosphamide will be administered at dose of 40mg/kg for 1 day and then fludarabine will be given for the next 5 days and then the T cells will be administered
Department of Oncology, Xinqiao Hospital
Chongqing, Chongqing Municipality, China
Safety: Measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Time frame: 4 weeks
Efficacy: Overall complete remission rate defined by the standard response criteria
Overall complete remission rate defined by the standard response criteria
Time frame: 8 weeks
Persistence: Duration of CAR-positive T cells in circulation
Duration of CAR-positive T cells in circulation
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.