A Phase I Study of an mRNA-Modified Dendritic Cell Vaccine in Patients with Multiple Myeloma as Consolidation Treatment after Autologous Stem Cell Transplantation

Protocol
13-009
Full Title
A Phase I Randomized Trial of Vaccination with CT7, MAGE-A3, and WT1 mRNA-electroporated Autologous Langerhans-type Dendritic Cells as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation
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 cancer 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.

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 tumor antigens in the vaccine in this study will be those associated with multiple myeloma.

The hope is that a dendritic cell vaccine based on this approach will trigger a strong immune response against multiple myeloma cells. The goal of this study is to determine the safety of this new vaccine and see what kind of immune response occurs when patients with multiple myeloma receive it after having an autologous stem cell transplant. The stem cells collected for the transplant will also be used to grow dendritic cells in the laboratory that will carry the tumor antigens, so each patient’s vaccine will be customized just for their cancer.

Patients in this study will be randomly assigned to receive the vaccine or no vaccine, and researchers will compare the two groups.

Eligibility

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

  • Patients must have multiple myeloma and have achieved a very good partial response or better following induction therapy.
  • Patients must be candidates for autologous stem cell transplantation.
  • Patients may not have been previously vaccinated with any of the components of the study vaccine.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. David Chung at 212-639-6617.

Disease(s)
Hematology: Multiple Myeloma
Locations
Related Diseases