Trial with TALL-104 Cells for Treatment of Metastatic Breast Cancer

Adoptive immunotherapy with the human MHC non-restricted cytotoxic T cell line TALL-1O4 has induced long-term complete or partial remissions in tumor bearing mice and pets with spontaneous tumors. The purpose of this study was to evaluate the safety of lethally irradiated TALL-104 cells in patients with metastatic breast cancer who had relapsed after conventional therapies. This was a single center, dose escalating study with 5 dose levels tested from 106 to 108 cellskg of body weight. The 15 patients enrolled 3 patientsdose received 5 intravenous daily injections of irradiated TALL-104 cells followed by 2-day monthly boosts at the same dose until disease progression. No clinical toxicity was observed even at the highest dose. Aside from individual variations, tests monitoring immunological parameters before and after cell administrations showed a common trend, including a a transient absolute and relative monocytosis and eosinophilia b slight neutropenia and c absence of humoral and cellular responses to TALL-104 cells. Some patients had stable disease for several months and one patient had a marginal clinical response to TALL- 104 cells as shown by a decrease in size of liver metastases and ascites. The overall data indicate that TALL-104 cells are well tolerated and might prove effective in adjuvant therapy of breast cancer.