Administration of Her2 Chimeric Receptor and TGFbeta Dominant Negative Receptor (DNR) Expressing EBV Specific Lymphocytes for Subjects With Advanced Her2 Positive Malignancy (HERCREEM)
The patient will give blood to grow T cells on either one to two separate occasions. Then,
the EBV-specific T cells will be made. These cells will be grown and frozen. To get the HER2
antibody (and the CD28) and the DNR to attach to the surface of the EBV-T cells, the
antibody gene and the DNR gene will be inserted into the EBV-T cell. This is done with two
viruses called retroviruses that have been made for this study. One will carry the antibody
gene into the T cell and the other the DNR gene.
When the patient is enrolled on the study, they will be assigned to a dose of HER2-DNR EBV-T
cells. The subject will be given one dose of cells 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. The treatment will be given by the Center for Cell and
Gene Therapy at Texas Children's Hospital or The Methodist Hospital.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine safety of one IV injection of autologous TGFBeta-resistant CTLs directed to Epstein Barr virus (EBV) through their native receptor and HER2 through their chimeric antigen receptor (CAR) in patients with advanced HER2-positive cancers.
Stepehen Gottschalk, 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|