A Study of GDX012 in Adults With Relapsed or Refractory Acute Myeloid Leukemia

Inclusion criteria:

1. Total body weight of ≥40 kg.

2. Must have pathologically confirmed relapsed or refractory acute myeloid leukemia (R/R AML) including:

3. Relapsed AML is defined as ≥5% blasts in the bone marrow (BM) or peripheralblood at any time after achieving a CR, CRh, Cri, or MLFS.

4. Refractory AML is defined as failure to achieve a CR, CRh, Cri, or MLFS after 1of the following regimens: i. Two courses of intensive induction chemotherapy. ii. At least 2 cycles ofhypomethylating agent (HMA) or low-dose, cytarabine-based combination regimen. iii. At least 4 cycles of HMA monotherapy.

5. During dose escalation, participants must be ineligible for hematopoietic stem celltransplantation (HSCT).

6. Must have an anticipated life expectancy of >3 months before lymphodepletion.

7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

8. Participants must have adequate renal, cardiac, hepatic, pulmonary and bone marrowfunction as defined by the protocol.

Exclusion criteria:

1. Diagnosis of acute promyelocytic leukemia.

2. Has received or plans to receive any of the excluded therapy/treatment within thespecified timeframe before lymphodepleting chemotherapy as defined by the protocol.

3. Prior allogeneic HSCT within 3 months of signing informed consent form (ICF) or withongoing requirement for systemic graft-versus-host therapy.

4. Active central nervous system (CNS) involvement.

5. History of malignancy other than non-melanoma skin cancer or carcinoma in situ (eg.cervix, bladder, breast) low grade prostate cancer without treatment requirementunless in remission without treatment for ≥2 years.