Clinical Trial

Disease: Breast Cancer, BC, (NCT05812326)

Disease info:

Breast cancer is a type of cancer that starts in the breasts and can spread to the rest of the body through the blood or lymphatic systems. 

There are many different types of breast cancer determined by the specific affected cells in the breast. Most breast cancers are carcinomas. The most common breast cancers such as ductal carcinoma in situ (DCIS) and invasive carcinoma are adenocarcinomas, since the cancers start in the gland cells in the milk ducts or the lobules. 

Breast cancers can also be classified by the presence or absence of proteins or genes such as estrogen receptors, progesterone receptors, and the HER2 gene or protein. Classification can ifluenca prognosis and treatment plans.

Approximately 1 in 10 breast cancers are associated with known inherited genetic variants. Many of these genes have not yet been discovered. Most breast cancers (about 90%) develop from acquired genetic variation that occurs independent of inheritence and many have not yet been identified. 

 

Frequency:
BC is the second most common cancer in women in the United States. It accounts for about 30% of all new female cancers each year. The American Cancer Society estimates 310,720 new cases of BC will be diagnosed in women in the United States in 2024.
Official title:
Exploratory Clinical Study of PD-1 Knockout Targeting MUC1 CAR-T Cells (AJMUC1) in the Treatment of MUC1-positive Advanced Breast Cancer
Who:
Sponsor:

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Partners:

Guangzhou Anjie Biomedical Technology Co., Ltd.

Locations:

Guangdong, China 
Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China, 510120
 

Study start:
May. 17, 2019
Enrollment:
15 participants
Gene editing method:
Type of edit:
Gene knock-out
Gene:
Programmed cell death protein 1 (PD-1)
Delivery method:
- Ex-vivo
IndicatorIndicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Completed

Description

This is a single-center, open-label, dose-escalation exploratory study investigating the safety,tolerability and preliminary efficacy of AJMUC1, PD-1 knockout CAR-T cells targeting aberrantly glycosylated MUC1, in the treatment of patients with advanced MUC1 positive breast cancer. The primary objective of this study is to evaluate the safety, tolerability, biological activity, and preliminary antitumor efficacy of AJMUC1. The study adopts a "3+3" dose escalation design to identify the maximum tolerated dose (MTD)/ maximum administered dose (MAD). Three doses are set: 3×105 CAR T cells/kg, 1×106 CAR T cells/kg and 3×106 CAR T cells/kg, with a total of 15 patients planned by the data cutoff date. Participants may receive one, two, three or more cycles of AJMUC1 infusion dependent on the adverse effects and potential clinical benefits.. This study is initiated by the investigators and approved by the Human Ethics Committee of Sun Yat-sen Memorial Hospital affiliated with Sun Yat-sen University. All patients have signed informed consent.

Last updated: Feb. 9, 2024
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