A Phase I Study of an mRNA-Modified Dendritic Cell Vaccine in Patients with Melanoma

Protocol
10-229
Full Title
Immune Responses to Autologous Langerhans-type Dendritic Cells Electroporated with mRNA Encoding a Tumor-associated Antigen in Patients with Malignancy: A Single-arm phase I trial in Melanoma
Phase
I
Purpose

Dendritic cells are powerful immune cells that can be modified to help white blood cells called T cells recognize and fight cancer cells. This modification is achieved by attaching tumor antigens (proteins found on tumor cells) to the dendritic cells and giving them back to a patient, where they can then activate the patient’s T cells against tumor cells, like melanoma.

Prior clinical trials have demonstrated that patients with advanced melanoma who received a dendritic cell vaccine experienced an immune response against their cancer cells. In this study, investigators are evaluating another version of this vaccine — one in which mRNA (messenger RNA, which cells use to make proteins) is inserted into the dendritic cells. This allows the dendritic cell to make the tumor antigen and present more of it to reactive T cells.

The hope is that a dendritic cell vaccine based on this approach will trigger a stronger immune response against melanoma cells than the previous version of the vaccine. The goal of this study is to determine the safety of this new vaccine and see what kind of immune response results when a patient receives it.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a confirmed diagnosis of melanoma (stage IIB-IV).
  • Patients’ white blood cells must express HLA-A*0201.
  • Patients must have already had surgery appropriate for their stage of disease.
  • At least 4 weeks must have passed since completion of prior therapy and entry into the study.

For more information about this study, please contact Dr. Jedd Wolchok at 646-888-2395, Dr. David Chung at 212-639-6617, or Dr. James Young at 646-888-2052.

Disease(s)
Melanoma
Locations
Related Diseases