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

Inclusion Criteria

• Total body weight of ≥40 kg.
• Must have pathologically confirmed relapsed or refractory acute myeloid leukemia (R/R AML) including:
• Relapsed AML is defined as ≥5% blasts in the bone marrow (BM) or peripheral blood at any time after achieving a CR, CRh, Cri, or MLFS.
• Refractory AML is defined as failure to achieve a CR, CRh, Cri, or MLFS after 1 of the following regimens: i. Two courses of intensive induction chemotherapy. ii. At least 2 cycles of hypomethylating agent (HMA) or low-dose, cytarabine-based combination regimen. iii. At least 4 cycles of HMA monotherapy.
• During dose escalation, participants must be ineligible for hematopoietic stem cell transplantation (HSCT).
• Must have an anticipated life expectancy of >3 months before lymphodepletion.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Participants must have adequate renal, cardiac, hepatic, pulmonary and bone marrow function as defined by the protocol.

Exclusion Criteria

• Diagnosis of acute promyelocytic leukemia.
• Has received or plans to receive any of the excluded therapy/treatment within the specified timeframe before lymphodepleting chemotherapy as defined by the protocol.
• Prior allogeneic HSCT within 3 months of signing informed consent form (ICF) or with ongoing requirement for systemic graft-versus-host therapy.
• Active central nervous system (CNS) involvement.
• History of malignancy other than non-melanoma skin cancer or carcinoma in situ (eg. cervix, bladder, breast) low grade prostate cancer without treatment requirement unless in remission without treatment for ≥2 years.