Study of GDX012 in Patients With MRD Positive AML

Inclusion Criteria:

≥ 18 years old
Weight ≥ 40 kg
Anticipated life expectancy > 3 months prior to lymphodepletion
Karnofsky Performance Score ≥ 70%
Histologically confirmed diagnosis of AML
In complete response (CR) (including CRi/CRp); patients in first, second or subsequent CR (including CRi/CRp) are permitted
MRD detected in bone marrow by MFC
Negative pregnancy test (females of childbearing potential only)
Agree to use effective birth control
Left ventricular ejection fraction (LVEF) ≥ 50%
Platelet Count ≥ 20 x 109/L
Prothrombin Time or INR ≤ 1.5 x ULN (unless receiving therapeutic anticoagulation)
Partial Thromboplastin Time ≤ 1.5 x ULN (unless receiving therapeutic anticoagulation)
Hemoglobin ≥ 8.0 g/dL
Creatinine Clearance ≥ 40mL/min
Serum Total Bilirubin ≤ 1.5 x ULN (unless documented Gilbert's Syndrome with Direct Bilirubin < 35% of Total Bilirubin)
ALT ≤ 2.5 x ULN

Exclusion Criteria:

Cytotoxic chemotherapy within 3 weeks
Immune therapy within 4 weeks
Immunosuppressive therapy within 2 weeks (with exceptions)
Investigational treatment or interventional clinical trial within 4 weeks or 5 half-lives (if known), whichever is longer
Major surgery within 4 weeks and/or not fully recovered from surgery-related toxicities
Known hypersensitivity to chemotherapy, other agents, or excipients used in this study
Female patient that is pregnant or lactating/breastfeeding
Ongoing toxicity from prior anti-cancer therapy that have not recovered to ≤ Grade 1 (with exceptions)
History of chronic or recurrent autoimmune or immune-mediated disease requiring steroids or other immunosuppressive treatments (including anti-tumor necrosis factor agents)
Active CNS involvement (i.e. leukemic infiltration)
Any other malignancy that requires active therapy
Uncontrolled intercurrent illness (i.e. acute coronary syndrome in the last 6 months)
Active infection with HIV, Hepatitis B or Hepatitis C

NOTE: other protocol defined inclusion/exclusion criteria may apply.