Donor-Derived Tumor-Associated Antigen-Specific T Cells in Treating Participants with Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Inclusion Criteria

• Patients will be eligible to receive donor-derived multiTAA-specific T cells following any type of allogeneic HSCT as * Adjuvant therapy for AML/MDS (Group A); or * Treatment for refractory/relapsed or minimal residual AML/MDS disease (Group B) ** Residual disease at the time of transplant or post transplant relapse is defined as polymerase chain reaction (PCR) positivity, specific cytogenetic abnormalities, an abnormal population on flow cytometry or increased blasts on bone marrow biopsy, in the peripheral blood, or any other extramedullary sites * Minimal residual disease (MRD) will be defined as detection in blood, bone marrow, or other tissues any of the following: ** Any leukemia specific marker such as t(8;21); inv 16; t (15;17), t(9;22) or t(4;11) documented in the patient’s leukemia cells pre-transplant on a post-transplant evaluation ** Expression of a leukemia associated antigen known to be a marker for residual disease like WT1 ** A leukemia-specific phenotype (e.g. expression of markers including CD13 and/or CD33 and/or CD117 and/or human leukocyte antigen–antigen D related positive [HLA-DR+]) post-transplant at a level of ≥ 0.01% ** Mixed donor chimerism (> 20%)
• Life expectancy ≥ 6 weeks
• Undergoing stem cell transplant at Center for Cell and Gene Therapy (CAGT)
• Karnofsky/Lansky score of ≥ 50
• Patient or parent/guardian capable of providing informed consent
• Bilirubin ≤ 2X upper limit of normal
• Aspartate transaminase (AST) ≤ 3X upper limit of normal
• Serum creatinine ≤ 2X upper limit of normal
• Hemoglobin (Hgb) ≥ 7.0 g/dL (can be transfused)
• Pulse oximetry of > 90% on room air
• Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the T cell infusion; male partner should use a condom
• Available donor-derived multiTAA-specific T cell line
• No other investigational anti-neoplastic therapy for one month prior to entry in this study
• DONOR ELIGIBILITY
• Donors for allogeneic (i.e. HLA matched or mismatched related or unrelated) stem cell transplants who have fulfilled eligibility for and consented to stem cell donation as per the stem cell transplant program's standard operating procedures
• Subjects must be at least 12 kg or 24 pounds to be eligible for stem cell donation

Exclusion Criteria

• Patients receiving antithymocyte globulin (ATG) or campath within 28 days of infusion
• Patients receiving a donor lymphocyte infusion within 4 weeks of planned T cell infusion
• Less than 30 days post-allogeneic stem cell transplant
• Severe intercurrent infection
• Evidence of graft versus host disease (GVHD) > grade II
• Pregnant or lactating
• Currently taking corticosteroids (> 0.5 mg/kg/day prednisone or equivalent)