Administration of Her2 Chimeric Antigen Receptor Expressing T Cells for Subjects With Advanced Sarcoma (HEROS)
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
The patient will be given an injection of cells into the vein through an IV line at the
assigned dose. 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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients with dose limiting toxicity after one injection of HER2-specific T cells
To determine the safety of one intravenous injection of autologous T cells expressing HER2-specific chimeric antigen receptor (CAR) in patients with advanced HER2-positive sarcoma.
Nabil M Ahmed, MD
Baylor College of Medicine/Texas Children's Hospital
United States: Institutional Review Board
|Texas Children's Hospital||Houston, Texas|
|The Methodist Hospital||Houston, Texas 77030|