Trial of Binary Oncolytic Adenovirus in Combination with HER2-Specific autologous CAR T cells (VISTA) (H-43405)

A Phase I Trial Of Intra-Tumor Injection Of A Binary Oncolytic Adenovirus (CADVEC) In Combination With Human Epidermal Growth Factor Receptor2-Specific Chimeric Antigen Receptor Adenovirus-Specific T Cells For Recurrent Or Metastatic HER2 Positive Solid Tumors

This study is a first in human Phase 1 study that involves patients with a type of cancer called HER2 (Human Epidermal Growth Factor Receptor 2) positive cancer.

This study asks patients to volunteer to take part in a research study investigating the safety and efficacy of using special immune cells called HER2 chimeric antigen receptor specific cytotoxic T lymphocytes (HER2 specific CAR T cells), in combination with intra-tumor injection of CAdVEC, an oncolytic adenovirus that is designed to help the immune system including HER2 specific CAR T cell react to the tumor.

The study is looking at combining these two treatments together, because we think that the combination of treatments will work better than each treatment alone. We also hope to learn the best dose level of the treatments and whether or not it is safe to use them together.

In this study, CAdVEC will be injected into participant’s tumor at one tumor site which is most easiest to reach. Once it infects the cancer cells, activation of the immune response will occur so it can attack and kill cancer cells. (This approach may have limited effects on the other tumor sites that have not received the oncolytic virus injection, so, patients will also receive specific T cells following the intratumor CAdVEC injection.) These T cells are special infection-fighting blood cells that can kill cells infected with viruses and tumor cells.

Investigators want to see if these cells can survive in the blood and affect the tumor. Both CAdVEC and HER2-specific autologous CAR T are investigational products. They are not approved by the FDA.

Age requirements: 18 years and older

More information about this study can be found on clinicaltrials.gov.

NCT#/ClinicalTrials.gov ID:03740256