The purpose of this study is to determine the safety and feasibility of CMV specific, T cell adoptive immunotherapy in patients who have undergone allogeneic stem cell transplantation for malignant disease.
The primary purpose of this clinical trial is to evaluate the safety of this treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
2
Donor derived CMV pp65 specific T cells (1 x 105 CD3+ cells/kg (maximum 1 x 107 CD3+ cells) will be infused into recipient over 10 minutes.
Duke University Medical Center
Durham, North Carolina, United States
Number of CMV pp65 specific CD8+ T cells produced.
Time frame: Pre-infusion.
Development of grade III-IV GVHD or major organ toxicity.
Time frame: Continuously for 100 days post-transplant.
Presence of CMV in peripheral blood.
Time frame: Tested before and following transplant and infusion.
Percentage of CD8+ T cells that are CMV pp65 specific.
Time frame: Assessed weekly up to 6 months following T cell infusion.
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