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.