A Phase 1 Study of WU-NK-101 in Patients With Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML)

Inclusion Criteria:

1. Confirmed diagnosis of primary or secondary AML (any subtype except acutepromyelocytic leukemia) according to World Health Organization (WHO) 2016classification

2. Unlikely to benefit from standard of care therapy

3. Patients with AML post hematopoietic stem cell transplant (HSCT) [permitted inCohort Expansion Phase only] must meet the following criteria:

• There must be histological confirmation of AML relapse after HSCT

• Undergone allogeneic HSCT (alloSCT) > 90 days prior to enrollment from a matchrelated donor, matched unrelated donor, cord blood donor, or haplo- identicaldonor

• Off all immunosuppressive medications for a minimum of 2 weeks

4. Adequate organ function as defined in the protocol

5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 at screening

Exclusion Criteria:

1. Circulating blast count >30,000/µL by morphology or flow cytometry (cytoreductivetherapies such as leukapheresis or hydroxyurea are allowed)

2. Uncontrolled or untreated bacterial, fungal, or viral infections, including HIV,Hepatitis B or C infection, or uncontrolled infection of any etiology

3. Uncontrolled angina, severe uncontrolled ventricular arrhythmias, orelectrocardiogram (ECG) suggestive of acute ischemia or active conduction systemabnormalities

4. Severe renal impairment, defined as creatinine clearance <40 mL/min