This is a single-center, single-arm, open label and dose escalation clinical study of anti-CD147 CART cells by hepatic artery infusions in patients with advanced hepatocellular carcinoma.
Patients autologous T cells are activated and then engineered to express chimeric antigen receptors (CARs) specific for CD147(CD147-CART). CAR-T cells are expanded in culture and returned to the patient by hepatic artery infusion at specific cell doses. Four CD147-CART doses patient are planned at 1-week intervals. Tumor biopsies will be obtained at the time of the initial diagnostic angiogram and during the first infusion session. Serum cytokine level and CAR-T cell number will be measured in whole treatment session.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Three infusions of CD147-CART cells over the course of three weeks into the hepatic artery.
Department of hepato-biliary & Pancreato Splenic Surgery Organ Transplant Center, Xijing Hospital
Xi'an, Shaanxi, China
RECRUITINGIncidence and type of adverse events induced by CD147-CART hepatic artery infusions
To assess the safety of CD147-CART (anti-CD147 CAR-T cell) hepatic artery infusions (HAI) for very advanced hepatocellular carcinoma which measured by number and type of adverse events.
Time frame: 12 weeks
DLT and MTD of CD147-CART cell hepatic artery infusions
To determine the dose limited toxicity (DLT) and maximum tolerated dose (MTD) of CD147-CART hepatic artery infusions.
Time frame: 12 weeks
Activity of CD147-CART cell hepatic artery infusions
To evaluate treatment response of CD147-CART hepatic artery infusions for very advanced hepatocellular carcinoma.
Time frame: 2 years
CD147-CART detection in extrahepatic sites
Quantification of CD147-CART cells in blood samples.
Time frame: 2 years
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