Her2 Chimeric Antigen Receptor Expressing T Cells in Advanced Sarcoma

Description

Because the cells have a new gene in them the patient will be followed for a total of 15 years to see if there are any long term side effects of gene transfer.

When the patient is enrolled on this study, they will be assigned a dose of HER2-CD28 T cells. Depending on which dose level they are assigned, they will receive one of the following:

HER2-CD28 T cells and fludarabine (patient will receive fludarabine for 5 days followed by injection of HER2-CD28 T cells)

OR

HER2-CD28 T cells, fludarabine and cyclophosphamide (patient will receive fludarabine and cyclophosphamide for 2 days, fludarabine alone for an additional 3 days, and 2 days of rest before receiving the HER2-CD28 T cells.).

The HER2-CD28 T cells will be given into the vein through an IV line. The injection will take between 1 and 10 minutes. The patient will be followed in the clinic after the injection for 1 to 4 hours.

Each patient will be followed for 6 weeks after the T-cell infusion for evaluation of toxicity. They will have standard tests and procedures as well as research blood draws.

If the patient has stable disease (the tumor did not grow) or there is a reduction in the size of the tumor on imaging studies after the T-cell infusion, they can receive additional doses of the T cells at 6 to 12 weeks intervals. For the first two subsequent HER2-specific T-cell infusions, patients will be able to receive additional lymphodepleting chemotherapy according to their dose levels.