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

Protocol
12-117
Full Title
A Phase I Trial of High Dose Therapy and Autologous Stem Cell Transplantation Followed by Infusion of Chimeric Antigen Receptor (CAR) Modified T-Cells Directed Against CD19+ B-Cells for Relapsed and Refractory Aggressive B Cell Non-Hodgkin Lymphoma
Phase
I
Disease Status
Relapsed/Refractory
Purpose

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.

Co-Investigators
Eligibility

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

  • Patients must have diffuse B-cell lymphoma or other aggressive B-cell lymphoma that is not responding to or has returned after standard therapy.
  • Patients may not have had a prior bone marrow or stem cell transplant.
  • This study is open to patients who are at least 18 years old but no older than 70.

For more information about this study and to inquire about eligibility, please contact Dr. Craig Sauter at 212-639-3460.

Disease(s)
Lymphoma: Non-Hodgkin's Lymphoma
Locations
Related Diseases