A Phase I Study of WT1-Specific Donor-Derived T Cells in Patients with Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia after T-Cell-Depleted Allogeneic Stem Cell Transplantation

Protocol
12-175
Full Title
A Phase I Dose Escalation Trial of WT1-specific Donor-derived T cells following T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation for Patients with Relapsed/Refractory Multiple Myeloma
Phase
I
Disease Status
Relapsed/Refractory
Purpose

Autologous stem cell transplant (ASCT) is a treatment for multiple myeloma in which some of a patient’s stem cells are removed before chemotherapy and returned to the patient to help re-establish the patient’s immune system after chemotherapy. However, in some patients, the myeloma returns quickly thereafter, or does not respond well to this treatment. Occasionally, the disease can also progress to what is called “plasma cell leukemia.

In this study, researchers are assessing the feasibility of using specialized white blood cells from a stem cell donor to treat patients with multiple myeloma that persists despite chemotherapy and ASCT, or those who have plasma cell leukemia. These cells, called Wilms tumor antigen 1 (WT1)-sensitized T cells, are grown in a lab and immunized against the WT1 protein, which is overproduced and expressed by malignant myeloma cells. These WT1-sensitized T cells are given after allogeneic stem cell transplantation (use of stem cells from a donor). It is hoped that the WT1-sensitized T cells, when given to the patients, will attach to the WT1 protein and kill the myeloma cells.

Eligibility

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

  • Patients must have multiple myeloma that has persisted despite ASCT, and/or they must have plasma cell leukemia
  • Patients must have a suitable donor who is willing to undergo the procedure to donate T cells to be modified and used in this study.
  • This study is open to patients who are at least 21 years old but younger than 70.

For more information about this study and to inquire about eligibility, please contact Dr. Guenther Koehne at 212-639-8599.

Disease(s)
Hematology: Multiple Myeloma
Locations
Related Diseases