Multiple Myeloma Clinical Trial
Official title:
A Phase I Study Investigating Safety Immunological Effects of Peripheral Blood T Lymphocytes Transduced With Anti LewisY Chimeric Receptor Gene in LewisY Positive Myeloma, Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome
Patients with some forms of acute myeloid leukemia (AML) and multiple myeloma (MM) are not
cured with conventional therapy and new approaches are needed. For the last 15 years we have
investigated the potential of using a patient's own T cells (a type of white blood cell
[WBC]) to eradicate the tumor. We have demonstrated the feasibility of this approach in cell
culture and animal models of AML and MM. Over the last 5 years we have been preparing to
treat patients as part of a Phase I (first in human) clinical trial.
The trial treatment involves collecting the patient's own WBCs from the blood by a standard
well established and safe process called apheresis. The cells are then cultured in a
specialized laboratory (under Good Manufacturing Practice conditions, similar to standards
under which pharmaceuticals are produced) over 12 days to convert the cells to specialized
tumor-attacking T cells. Early in that culture process the cells are exposed to a virus
(that is modified so that it cannot infect or replicate outside the special culture
conditions) that contains a special gene. Via the virus, this gene inserts into the
patient's T cells in culture and gets incorporated into the T cell's genetic machinery. As
the T cells replicate, the new gene produces a protein receptor that becomes part of the
patient's T cells. This protein receptor on the T cells has the capacity to specifically
recognize and bind to a protein on the leukemia or myeloma cells called the "Lewis Y"
antigen.
After the modified T cells are infused into the patient, they home into the bone marrow
(this tracking is monitored by special radiological techniques) where the new protein
receptor on the T cell surface can recognize and bind to the cancer cells (which express
Lewis Y). Once bound onto the cancer cells, the T cells get activated and subsequently
replicate and kill the cancer cells. The novelty of this approach is that the T-cells will
only kill cells that have the Lewis Y on their surface - the cancer cells. Moreover, because
there are few normal cells in a person's body that carry Lewis Y, this treatment is likely
to only have minor side effects.
This gene therapy trial is unique and although the primary purpose is to test the safety of
this approach, patients will be monitored closely for anti-tumor responses. As the trial
progresses, the dose of T cells infused will increase, in the hope that this will result in
a better and stronger immune response to the leukemia or myeloma.
n/a
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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