Long-term follow up for a phase I trial HER2/neu-targeted T cells in women with advanced breast cancer.

3075 Background: Anti-CD3 x anti-Her2 bispecific antibody (Her2Bi) retargeting transforms activated T cells (ATC) into non-restricted MHC specific cytotoxic T cells. This study reports a phase I immunotherapy trial beginning in 2001 (NCT00027807) in 23 women with Her2 0-3+ metastatic breast cancer consisting of 8 infusions of HER2Bi armed ATC (aATC) in combination with interleukin 2 (IL-2) and granulocyte-macrophage-colony stimulating factor to evaluate safety, feasibility, time to progression, median overall survival (OS), T cell trafficking and immune responses. Methods: ATC were expanded in IL-2 after anti-CD3 stimulation of mononuclear cells obtained from leukapheresis. Groups of 3 patients (pts) received 5, 10, 20, or 40 x 10e9 aATC per infusion. Results: Total episodes of Grade III-IV side effects for 23pts in decreasing order were chills, headache, nausea/vomiting, back pain, hypertension, and death of 1 pt from congestive heart failure due to digoxin toxicity. aATC persisted in the blood for a wee...