Study of Adoptive Cellular Therapy Using Autologous T Cells Transduced With Lentivirus to Express a CD33 Specific Chimeric Antigen Receptor in Patients With Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia

Inclusion Criteria:

1. Age 1-80 years of age. The pediatric cohort is defined as age younger than 18 years.

2. Patients with active (blood or bone marrow blasts >5%) relapsed or refractory CD33+
acute myeloid leukemia (AML) de novo, or secondary. a. Relapsed AML is defined as
patients that had a first complete remission (CR) before developing recurrent disease.
b. Refractory AML defined as patients that have not achieved a CR after 2 cycles of
induction chemotherapy.

3. Patients must have bone marrow and peripheral blood studies available for confirmation
of diagnosis of AML; CD33 positivity must be confirmed by either flow cytometry or
immunohistochemistry; cytogenetics, flow cytometry, and molecular studies (such as
FMS-like tyrosine kinase-3 [Flt-3] status) will be obtained as per standard practice.

4. ECOG performance status score
5. Pretreatment calculated or measured creatinine clearance (absolute value) of >= 60
mL/minute.

6. Serum bilirubin =< 3.0 mg/dL.

7. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 5 times the
institutional upper limits of normal.

8. Ejection fraction measured by echocardiogram (ECHO) or multi gated acquisition scan
(MUGA) >50%.

9. Subject does not require supplemental oxygen or mechanical ventilation, and oxygen
saturation by pulse oximetry is 94% or higher on room air.

10. Negative serum pregnancy test.

11. Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control or abstinence) prior to study entry and
for six months following duration of study participation; should a woman become
pregnant or suspect that she is pregnant while participating on the trial, she should
inform her treating physician immediately.

12. Patients who have undergone allo-SCT are eligible if they are at least 3 months post
SCT, have relapsed AML, are not on treatment or prophylaxis for GVHD, and have no
active GVHD.

13. All patients or legally responsible parent or guardian must have the ability to
understand and willingness to sign a written informed consent

Exclusion Criteria:

1. Diagnosis of acute promyelocytic leukemia (APL M3): t(15;17)(q22;q12); (promyelocytic
leukemia [PML]/retinoic acid receptor [RAR] alpha [a]) and variants excluded.

2. Patients with extramedullary disease as their sole site of relapsed AML.

3. Acceptable allogeneic stem cell donor with imminent plans to proceed with allo-SCT.

4. Known central nervous system (CNS) leukemic involvement that is refractory to
intrathecal chemotherapy and/or cranio-spinal radiation; patients with a history of
CNS disease that have been effectively treated to complete remission (< 5 white blood
cell [WBC]/mm^3 and no blasts in cerebrospinal fluid [CSF]) will be eligible.

5. Ongoing or active or uncontrolled infection, symptomatic congestive heart failure,
unstable angina pectoris, cardiac arrhythmia, poorly controlled pulmonary disease or
psychiatric illness/social situations that would limit compliance with study
requirements.

6. Human immunodeficiency virus (HIV) seropositivity, or active hepatitis B or C
infection based on testing performed within 4 weeks of enrollment.

7. Currently enrolled in another investigational therapy protocol for AML.

8. Participants with presence of other active malignancy within 2 years of study entry;
participants with history of prior malignancy treated with curative intent and
achieved CR within 2 years are eligible.

9. Pregnant and lactating women are excluded from this study

10. Failure of research participant or legally responsible parent or guardian to
understand the basic elements of the protocol and/or the risks/benefits of
participating in this phase I study.

11. History of allergic reactions attributed to compounds of similar chemical or
biological composition to cetuximab (anti-EGFR).

12. History of allergic reactions to products containing mouse and bovine protein
antibodies.

13. Receiving corticosteroids at >20 mg (age >17) or >0.5mg/kg (age <18) daily prednisone
dose or equivalent.

14. Active autoimmune disease requiring systemic immunosuppressive therapy.

15. Patient, who in the opinion of the investigator, may not be able to comply with the
safety monitoring requirements of the study.