Other Solid Tumors Clinical Trial
Official title:
Phase IB Followed by Phase II Study of Trastuzumab Combined With Autologous Chimeric Receptor T Cells in HER2+ Advanced Breast Cancer and Other Solid Tumors
This phase Ib study aims to assess the safety and feasibility of combination of chimeric receptor T cells with trastuzumab in patients with HER2+ solid tumors, with further expansion of study population in HER2+ metastatic breast cancer once safety has been established.
Hypothesis Investigators hypothesize that trastuzumab-mediated cytotoxicity will be augmented by the infusion of autologous chimeric receptor T-cells. Primary Objectives 1. To determine the safety of autologous chimeric receptor T-cells in patients with HER2+ advanced solid tumors 2. To determine the clinical benefit rate (CBR) of autologous chimeric receptor T-cells in patients with HER2+ advanced breast cancer Secondary Objectives 1. To determine the expansion and persistence of autologous chimeric receptor T-cells after a single infusion in patients with advanced solid tumors 2. To determine anti-tumor efficacy in terms of objective response rate (ORR) and progression-free survival (PFS) of autologous chimeric receptor T-cells in patients with HER2+ advanced breast cancer ;
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