UPCC 5196:PHASE I TRIAL W/ TALL 104 CELLS FOR THERAPY OF METASTATIC BREAST CANCER

本研究的目的是评估TALL-104细胞在转移性乳腺癌患者中的效果，并研究这些细胞的副作用和毒性剂量水平。 为了做到这一点，不同剂量的TALL- 104细胞将被给予转移性乳腺癌志愿者。 参与这项试验的第一批妇女将被给予低剂量的TALL-104细胞。 如果没有发生显著的副作用，下一组志愿者将接受更高的剂量，并且这种“剂量递增”将继续，直到1）确定引起太多副作用的剂量或2）剂量已经增加4倍至本研究中使用的最高剂量。

The purpose of this study is to evaluate the effect of TALL-104 cells in patients with metastatic breast cancer, and to study the side effects and toxic dose levels of these cells. In order to do this, varying doses of TALL- 104 cells will be given to volunteers with metastatic breast cancer. The first women involved in this trial will be given a low dose of TALL-104 cells. If no significant side effects occur, the next group of volunteers will receive a higher dose, and this "dose escalation" will continue until either 1) a dose is identified that causes too many side effects or 2) the dose has been increased 4 tims to the highest dose to be used in this study.