Administration of Donor Multi TAA-Specific T Cells for AML or MDS (ADSPAM)

To make donor derived multiTAA-specific T cells, the investigators will collect blood from
the patient's stem cell donor, and mix the donor's T cells with small pieces of tumor
proteins WT1, PRAME, NY-ESO-1, and Survivin. These protein fragments stimulate the donor T
cells to grow and react against these proteins in such a way that they will recognize and
kill cancer cells that express these proteins. Once sufficient numbers of multiTAA-specific T
cells have been made, the investigators test them to make sure they target the patient's
cancer cells, but not their normal healthy cells.

The multiTAA-specific T cells will be administered as a single intravenous (IV) infusion over
10 minutes. The patient's cancer will be assessed within 4 weeks prior to the T cell
infusion, and then 4-6 weeks after the infusion. If at least 4 weeks after the infusion there
is no change or a reduction in the number of cancer cells measured in the bone marrow, or a
decline in cancer-specific markers in the blood, patients may receive up to six (6)
additional doses of T cells at least 4 weeks apart. All of the treatments will be given by
the Center for Cell and Gene Therapy at Houston Methodist Hospital or Texas Children's
Hospital.

For at least 4 weeks after the infusion, patients may not receive any other anti-cancer
treatments, such as radiation therapy, or chemotherapy. Patients who do receive any other
therapies will be taken off treatment and will not be able to receive additional doses of T
cells. However, drugs such as 5-azacytidine (Vidaza), decitabine (Dacogen), or lenalidomide
(Revlimid) will be allowed during infusions.

This is a dose escalation study, which means that at the beginning, patients will be started
on the lowest dose (1 of 3 different levels) of T cells. Once that dose level proves safe,
the next group of patients will be started at the next highest dose. This process will
continue until all 3 dose levels have been studied. If side-effects are too severe, the dose
will be lowered or the T cells injections will be stopped.

MEDICAL TESTS BEFORE TREATMENT:

Before being treated, patients will undergo a series of standard medical tests:

- Measurement of AML/MDS (done by bone marrow biopsy or tests on blood or other tissues)

- Pregnancy test, if patient is a female who can have children.

MEDICAL TESTS DURING TREATMENT

Patients will undergo standard medical tests on the day of infusion:

- Physical exam.

- Blood test to measure blood cells, kidney and liver function.

MEDICAL TESTS AFTER TREATMENT:

- Blood tests to measure blood cells, kidney and liver function on week 4.

- Measurement of AML/MDS 4-6 weeks after the T cells infusion and 8-12 weeks after the
infusion (done by bone marrow biopsy and tests done on your blood or other tissues).

To learn more about the way the T cells are working in the patient's body, an extra 20-40 mL
(4-8 teaspoons) of blood will be taken before the infusion, and at weeks 1, 2, 4 and 8.
Afterwards, blood will be collected at 3, 6, 9 and 12 months after the infusion. Blood should
come from the central intravenous line, and should not require extra needle sticks.
Investigators will use this blood to see how long the T cells last, and to look at the immune
response to the patient's cancer. Investigators will also look at this in bone marrow and
other tissue samples collected from the patient at the time points stated above
(pre-infusion, 4 - 6 weeks and 8 - 12 weeks post infusion).

Patients will be followed for up to one year from the date of the last T cell infusion, so
that the investigators can learn more about the way the T cells are working, how long the T
cells last in the body, and to assess the immune response to the cancer. Patients who receive
additional doses of T cells will undergo the same tests and evaluations performed for each
dose as described above.

Patients will then be contacted once a year for up to 4 additional years (total of 5 years
follow-up) to evaluate their disease response long-term.

Inclusion Criteria:

1. Patients will be eligible to receive donor-derived multiTAA-specific T cells following
any type of allogeneic HSCT as;

(i) Adjuvant therapy for AML/MDS (Group A) or

(ii) 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
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 of any of the following:

(i) 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.

(ii) Expression of a leukemia associated antigen known to be a marker for residual
disease like WT1.

(iii) A leukemia-specific phenotype (e.g. expression of markers including CD13 and/or
CD33 and/or CD117 and/or HLA-DR+) post-transplant at a level of ≥ 0.01%.

(ix) Mixed donor chimerism (> 20%).

2. Life expectancy ≥ 6 weeks.

3. Karnofsky/Lansky score of ≥ 50.

4. Patient or parent/guardian capable of providing informed consent.

5. Bilirubin ≤ 2X upper limit of normal.

6. AST ≤ 3X upper limit of normal.

7. Undergoing stem cell transplant at CAGT.

8. Serum creatinine ≤ 2X upper limit of normal.

9. Hgb > 8.0 g/dL (can be transfused).

10. Pulse oximetry of > 90% on room air.

11. 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.

12. Available donor-derived multiTAA-specific T cell line.

13. No other investigational anti-neoplastic therapy for one month prior to entry in this
study.

Exclusion Criteria:

1. Patients receiving ATG or Campath within 28 days of infusion.

2. Patients receiving a Donor Lymphocyte Infusion within 4 weeks of planned T cell
infusion.

3. Less than 30 days post-allogeneic stem cell transplant.

4. Severe intercurrent infection.

5. Evidence of GVHD > Grade II.

6. Pregnant or lactating.

7. Currently taking corticosteroids (> 0.5 mg/kg/day prednisone or equivalent).