Disease: Esophageal Cancer, (NCT03081715)

Disease info:

The esophagus (ĕ-sof´ah-gus) is the hollow, muscular tube that moves food and liquid from the mouth to the stomach. The wall of the esophagus is made up of several layers of tissue, including muscle, connective tissue that supports the framework of the body, and an inner lining called the mucosa.

Cancer of the esophagus (also called esophageal cancer) starts in the inner layer (the mucosa) and grows outward (through the submucosa and the muscle layer). Since 2 types of cells can line the esophagus, there are 2 main types of esophageal cancer:

The esophagus is normally lined with squamous cells. Cancer starting in these cells is called squamous cell carcinoma. This type of cancer can occur anywhere along the esophagus, but is most common in the portion of the esophagus located in the neck region and in the upper two-thirds of the chest cavity.  

Cancers that start in gland cells  (cells that make mucus) are called adenocarcinomas.This type of cancer usually occurs in the distal (lower third) part of the esophagus. Before an adenocarcinoma can develop, gland cells must replace an area of squamous cells, which is what happens in Barrett’s esophagus. This occurs mainly in the lower esophagus, which is where most adenocarcinomas start.

Frequency:
The American Cancer Society’s estimates for esophageal cancer in the United States for 2020 are: About 18,440 new esophageal cancer cases diagnosed (14,350 in men and 4,090 in women) About 16,170 deaths from esophageal cancer.
Official title:
Safety and Activity of Programmed Cell Death-1 Knockout Engineered T Cells in Patients With Previously Treated Advanced Esophageal Squamous Cell Carcinoma: An Open-label, Single-arm Phase 1 Study
Who:
Partners:

Anhui Kedgene Biotechnology Co.,Ltd

Locations:

China, Zhejiang

Study start:
Mar. 14, 2017
Enrollment:
16 participants
Gene editing method:
CRISPR-Cas9
Gene:
PDCD1 Programmed cell death protein 1
Delivery method:
No information - Ex-vivo
Note:
Peripheral blood lymphocytes were collected and Programmed cell death 1(PD-1) gene was knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes were selected and expanded ex vivo and reinfused back into patients.
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Completed

Description

This study will evaluate the safety of PD-1 knockout engineered T cells in treating advanced esophageal cancer. Blood or tissue samples will also be collected for research purposes.

This is a prospective clinical study of ex-vivo selected, engineered, and expanded PD-1 knockout T cells from autologous origin. 16 advanced esophageal cancer patients are planned to receive two cycles of PD-1 knockout engineered T cells infusion. Immunological markers are analyzed as well.

Last updated: Aug. 1, 2020
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