Clinical Trial

Disease: Solid Tumor, Adult, (NCT04976218)

Disease info:

An abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumours may be benign (not cancer), or malignant (cancer). Different types of solid tumours are named for the type of cells that form them. Examples of solid tumours are sarcomas, carcinomas, and lymphomas. Leukemias (cancers of the blood) generally do not form solid tumours.

Frequency:
More than 1.9 million new cancer cases are expected to be diagnosed in the US in 2023.
Official title:
Phase Ⅰ Study of EGFR Targeted TGFβR-KO CAR T Cells in the Treatment of Previously Treated Advanced EGFR-positive Solid Tumors
Who:

Contact

Name: Weidong Han, PhD

Phone: +86-10-66937463

Email: hanwdrsw69@yahoo.com


Name: Kaichao Feng, MD

Phone: +86-10-66937231

Email: timothyfkc@126.com

Sponsor:

Chinese PLA General Hospital

Partners:
Locations:

China, Beijing

Chinese PLA General Hospital, Beijing, Beijing, China, 100853

Study start:
Mar. 15, 2022
Enrollment:
30
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene knock-out
Gene:
TGF-β receptor (TGFβR)
Delivery method:
- Ex-vivo
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

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: Dec. 28, 2023
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