The purposes of the study are to determine the maximum tolerated dose (MTD) and effectiveness of Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion after an allogeneic hematopoietic cell transplant (alloHCT) to treat patients with Acute Myeloid Leukemia (AML).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Donor cells will be processed in a laboratory, where T-cell subtype called γδ (gamma delta) T-cells will be isolated and expanded in number. These T-cells expanded in a laboratory will be infused in participants who are otherwise at high risk of AML recurrence after alloHCT.
Moffitt Cancer Center
Tampa, Florida, United States
Maximum Tolerated Dose
Maximum Tolerated Dose will be determined by testing increasing doses of AAPC-expanded donor γδ T-cells.
Time frame: Up to 12 months
Dose Expansion: Leukemia Free Survival
Leukemia-free survival is defined as the time from the date of start of treatment to the date of relapse of AML or death from any cause
Time frame: Up to 12 months
Number of Participants with Graft Versus Host Disease (GVHD)
Number of participants with grade II-IV and III-IV acute GVHD within 6 weeks after infusion of Gamma T cells
Time frame: at 6 weeks
Overall Survival (OS)
The length of time from start of treatment to death by any cause.
Time frame: Up to 12 months
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