C7R-GD2.CAR T Cells for Patients with Relapsed or Refractory Neuroblastoma and Other GD2 Positive Cancers (GAIL-N)
This study is for patients with neuroblastoma, sarcoma, uveal melanoma, breast cancer, or other cancers that express GD2. The cancer has either come back after treatment or did not respond to treatment. Because there is no standard treatment at this time, patients are asked to volunteer in a gene transfer research study using T cells.
We have found from previous research that we can put a new gene into T cells that will make them recognize cancer cells and kill them. In a previous clinical trial we made a gene called a chimeric antigen receptor (CAR) from an antibody that recognizes GD2, a substance found on almost all neuroblastoma cells (GD2-CAR). We put this gene into the patients' own T cells and gave them back to 11 neuroblastoma patients. We saw that the cells did grow for a while, but started to disappear from the blood after 2 weeks. We think that if T cells are able to last longer they may have a better chance of killing GD2 positive tumor cells.
Therefore, in this study we will add a new gene to the GD2 T cells that can cause the cells to live longer. T cells need substances called cytokines to survive and the cells may not get enough cytokines after infusion. We have added the gene C7R that gives the cells a constant supply of cytokine (Interleukin-7) and helps them to survive for a longer period of time. GD2 T Cells with C7R will be generated from blood obtained by a simple blood draw (approximately 2-3 ounces).
In other studies using T cells, investigators found that giving chemotherapy before the T cell infusion can improve the amount of time the T cells stay in the body and therefore the effect the T cells can have. This is called lymphodepletion and we think that it will allow the T cells to expand and stay longer in the body, and potentially kill cancer cells more effectively.
- Ages Eligible for Study: 1-74 years
- Sexes Eligible for Study: All
- Evaluable neuroblastoma with persistent or relapsed disease
OR Relapsed or refractory osteosarcoma not responsive to standard treatment
OR Patients diagnosed with GD2 positive metastatic uveal melanoma and progressed after at least one prior systemic treatment
OR GD2 positive breast cancer with metastatic or locally recurrent unresectable breast cancer currently progressive after at least two prior lines of therapy in the advanced setting
OR Patients with other relapsed or refractory solid tumors (note: such as rhabdomyosarcoma and other sarcomas) not responsive to standard treatment with confirmed expression of GD2
- Detailed inclusion and exclusion criteria as listed on clinicaltrials.gov.