Spots Global Cancer Trial Database for PD-1 Knockout Anti-MUC1 CAR-T Cells in the Treatment of Advanced Breast Cancer

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Trial Identification

Brief Title: PD-1 Knockout Anti-MUC1 CAR-T Cells in the Treatment of Advanced Breast Cancer

Official Title: Exploratory Clinical Study of PD-1 Knockout Targeting MUC1 CAR-T Cells (AJMUC1) in the Treatment of MUC1-positive Advanced Breast Cancer

Study ID: NCT05812326

Conditions

Advanced Breast Cancer

Breast Neoplasm Malignant Female

Interventions

AJMUC1- PD-1 gene knockout anti-MUC1 CAR-T cells

Study Description

Brief Summary: This exploratory clinical study aims to assess the safety and preliminary efficacy of an immunotherapy using PD-1 knockout anti-MUC1 CAR-T cells in the treatment of advanced MUC1-positive breast cancer

Detailed 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.