Clinical Trial

Disease: Billiary Tract Cancer, BTC, (NCT04976218)

Disease info:

Biliary tract cancer is a cancer that forms in the cells of the bile ducts, gallbladder or ampulla of Vater. Cancer of the bile ducts is called cholangiocarcinoma and is classified depending on which part of the bile duct the cancer develops in: intrahepatic (affects bile ducts within the liver), hilar (occurs at the junction of the left and right hepatic ducts) and extrahepatic (affects the common bile duct outside the liver). Gallbladder cancer originates in the cells of the gallbladder. Ampullary cancer develops in the ampulla of Vater, where bile ducts from the liver and pancreas join and enter the duodenum.

The American Cancer Society’s estimates for billiary tract cancer in the United States for 2021 are: About 8000 new cases of BTC.
Official title:
Phase Ⅰ Study of EGFR Targeted TGFβR-KO CAR T Cells in the Treatment of Previously Treated Advanced EGFR-positive Solid Tumors

Principal investigator: Weidong Han, PhD    Biotherapeutic Department, Chinese PLA General Hospital


Chinese PLA General Hospital


Han weidong, Chinese PLA General Hospital


China, Beijing

Study start:
Mar. 15, 2022
Gene editing method:
Type of edit:
Gene knock-out
TGF-β receptor (TGFβR)
Delivery method:
- Ex-vivo
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting


Chimeric antigen receptor-modified T (CAR-T) cell therapy has been identified as a breakthrough therapy in haematologic malignancies. In contrast to the promising efficacy seen in leukaemia, lymphoma and multiple myeloma, however, CAR-T cell therapy has not yielded satisfactory efficacy data in the study of solid tumours. One of the major challenges is the complicated immunosuppressive tumour microenvironment (TME) in solid tumours. It has been reported that transforming growth factor-β (TGF-β) is one of the major regulatory factors in the TME, which plays a key role in promoting tumour initiation, metastasis, and suppressing anti-tumour immunity. In this Phase Ⅰ study, the sponsors plan to construct CAR-EGFR-TGFβR-KO T cells by knocking out TGF-β receptor Ⅱ through CRISPR-Cas9 genome-editing technology in order to study the anti-tumour activities and safety profiles of CAR-EGFR-TGFβR-KO T cells in the treatment of advanced unresectable or metastatic biliary tract cancer.

Last updated: Apr. 10, 2022
Source: US National Institutes of Health (NIH)
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