Disease: Advanced Hepatocellular Carcinoma, HCC, (NCT04417764)

Disease info:

Liver cancer begins in the cells of the liver. The most common form of liver cancer begins in cells called hepatocytes and is called hepatocellular carcinoma (HCC).

The risk of hepatocellular carcinoma, is higher in people with long-term liver diseases. It's also higher if the liver is scarred by infection with hepatitis B or hepatitis C. Hepatocellular carcinoma is more common in people who drink large amounts of alcohol and who have an accumulation of fat in the liver.

 

Frequency:
HCC accounts for 65% of all cases of liver cancers. The incidence rate of HCC in the US, has increased from 1.4/100,000 cases/year between 1976–1980 to 6.2/100,000 cases reported in 2011.
Official title:
Safety and Effect Assessment of TACE in Combination With Autologous PD-1 Knockout Engineered T Cells by Percutaneous Infusion in the Paitents With Advanced Hepatocellular Carcinoma.
Who:

Wei Wang, MD, Principal for The Institute for Cell Transplantation and Gene Therapy, Central South University

Partners:
Locations:

China, Hunan

Study start:
Jun. 20, 2019
Enrollment:
10 participants
Gene editing method:
CRISPR-Cas9 knockout-T cells from autologous origin
Gene:
PDCD1 Programmed cell death protein 1
Delivery method:
ex vivo plasmid based guideRNA and Cas9 delivery by electroporation - Ex-vivo
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

This is a clinical study to investigate the safety and effect of transcatheter arterial chemoembolization (TACE) in combination with PD-1 knockout engineered T cells in the Patients with advanced hepatocellular carcinoma. TACE would block the blood supply of the tumor to achieve ischemic, hypoxic and necrotic effects. The PD-1 knockout engineered T cells were also prepared from autologous origin using CRISPR Cas9 technology. The patients performed one TACE treatment followed by 3 cycles of PD-1 edited T cells by percutaneous infusion in the peripheral of tumor under the guide of CT every four weeks. The safety and clinical efficacy will be evaluated. biomarkers and immunological markers will be monitored.

Last updated: Aug. 8, 2020
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