NCT02547961

Chimeric Antigen Receptor-Modified T Cells for Breast Cancer

Chimeric Antigen Receptor-Modified T Cells for HER-2 Positive Recurrent and Metastatic Breast Cancer

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fuda Cancer Hospital, Guangzhou · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of HER2-CAR-T cell Infusion for advanced HER2 positive breast cancer.

Detailed description

By enrolling patients with advanced HER2 positive breast cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of HER2-CAR-T cell infusion for advanced HER2 positive breast cancer.The CAR consists of a HER-2 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and CD28. Autologous T cells will be gene-engineered with the CAR gene using a retrovirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	HER-2-targeting CAR T Cells infusion	HER-2-targeting CAR t cells infusion in breast cancer

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-08-15
• Completion: 2016-08-15
• First posted: 2015-09-14
• Last updated: 2020-07-16

Locations

1 site across 1 country: China