A Phase I Study of High-Dose Therapy and Autologous Stem Cell Transplantation Followed by Modified T Cells for Aggressive B-Cell Non-Hodgkin Lymphoma

Aggressive B-cell non-Hodgkin lymphoma (NHL) is challenging to treat with chemotherapy alone. Higher doses of chemotherapy are sometimes used, but this approach can lower a patient’s blood counts. High-dose chemotherapy may therefore be paired with autologous stem cell transplantation, in which some of a patient’s blood-forming stem cells are removed before chemotherapy is completed and then returned after treatment to help re-establish a new immune and blood-forming system.

In this study, researchers are evaluating an additional step to this treatment regimen: the addition of specially modified white blood cells called T cells, which target a protein on B-cell NHL cells called CD19. Some T cells are removed from the patient in the same way stem cells are removed, and in the laboratory, scientists insert a gene into the T cells to make them recognize and possibly kill lymphoma cells. It is hoped that giving these modified T cells back to the patient after stem cell transplantation will be more effective for treating aggressive B-cell NHL.

The purpose of this study is to find the highest dose of these modified T cells that can be safely given to patients receiving this treatment regimen.