The purpose of this study is to evaluate the safety and efficacy of HER2-CAR-T cell Infusion for advanced HER2 positive breast cancer.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
HER-2-targeting CAR t cells infusion in breast cancer
Central laboratory in Fuda cancer hospital
Guangzhou, Guangdong, China
Number of participants with Adverse events
Time frame: 24weeks
Tumor load
Tumor load will be quantified with radiology, bone marrow and/or blood
Time frame: 24weeks
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