Phase I/II Study of Adoptive Immunotherapy After Allogeneic HCT With Virus Specific CD8+ T Cells That Have Been Transduced to Express a WT1-specific T Cell Receptor for Patients With High Risk or Relapsed AML, MDS, or CML
I. Determine the safety and potential toxicities associated with treating patients with high
risk or relapsed AML, MDS and CML after allogeneic hematopoietic cell transplantation (HCT)
by adoptive transfer of virus-specific cluster of differentiation (CD)8 T cells
genetically-modified to express a high affinity Wilms tumor 1 (WT1)-specific T cell receptor
(TCR) (WT1-sensitized T cells).
II. Determine the anti-leukemic activity associated with treating patients with relapsed
AML, MDS and CML after allogeneic HCT by adoptive transfer of virus-specific CD8 T cells
genetically-modified to express a high affinity WT1-specific T cell receptor (TCR).
I. Determine the in vivo persistence of transferred T cells and ability to migrate to and
accumulate in bone marrow.
II. Determine the maintenance of TCR expression and function of transduced T cells.
OUTLINE: Patients are assigned to 1 of 2 treatment arms.
ARM I: Patients with no evidence of disease post-HCT receive WT1-sensitized T cells
intravenously (IV) over 1-2 hours on days 0, 28, 56, and 84 (stage I) or 0, 14, 28, and 42
(stage II) and aldesleukin subcutaneously (SC) twice daily (BID) on days 84-98 (stage I) or
42-56 (stage II).
ARM II: Patients with minimal residual disease or over disease post-HCT receive
WT1-sensitized T cells IV over 1-2 hours on days 0, 14, 28, and 42 (stage I) or 0, 14, and
28 (stage II) and aldesleukin SC BID on days 42-56 (stage I) or 28-42 (stage II).
After completion of study treatment, patients are followed up at 3, 6, 12 months, and then
annually for up to 15 years.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity rate associated with infusing WT1-sensitized T cells in patients at high risk for post-transplant AML, MDS or CML relapse, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 4.0 (arm I)
Up to 15 years
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|