WU-NK-101: This study is aims to determine the recommended dose level, safety and effectiveness of a new drug (called WU-NK-101) in people with relapsed or refractory acute myeloid leukaemiaA Phase 1 Study of WU-NK-101 in Patients With Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML)

Inclusion

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

2. Unlikely to benefit from standard of care therapy defined by any one of the following criteria:

   1. Primary induction failure (PIF) defined as leukemia refractory to ≥ 1 induction attempts. Induction attempts include 1 high-dose and/or 2 standard-dose cytarabine

      • an anthracyclines/anthracenedione ± an anti-metabolite, with or without growth factor or targeted therapy containing regimens.

   2. For adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy; PIF is defined as AML refractory to one of the following less intensive regimens:

      • ≥ 2 but ≤ 4 cycles of Bcl-2 inhibitors in combination with azacitidine, decitabine, or low dose cytarabine
      • ≥ 2 but ≤ 4 cycles of gemtuzumab ozogamicin monotherapy
      • ≥ 6 but ≤ 8 cycles ivosidenib or enasidenib

   3. Leukemia in relapse after achieving CR

      • Early Relapse: disease recurrent within ≤ 6 month of documented remission
      • Late Relapse: disease recurrent within > 6 month of documented remission
      • Refractory-Relapse: refractory to ≥ 1 unsuccessful salvage attempts

3. Patients with AML post hematopoietic stem cell transplant (HSCT) [permitted in Cohort 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 match related donor, matched unrelated donor, cord blood donor, or haplo- identical donor
   • Off all immunosuppressive medications for a minimum of 2 weeks with the exception of physiologic doses (<10 mg) of corticosteroids
   • No history of Grade ≥ 3 veno-occlusive disease, or active graft versus host disease
4. Patients with known central nervous system (CNS) involvement with AML are eligible if they have been treated and cerebrospinal fluid is clear for at least 2 weeks prior to enrollment into the study. CNS therapy (radiotherapy or chemotherapy) should continue as medically indicated during the study treatment.
5. Patients with extramedullary disease are permitted if bone marrow blast count is >5%
6. Adequate organ function as defined in the protocol
7. Life expectancy >12 weeks
8. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 at screening