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

Completed · Phase 1

Conditions studied: Acute Myeloid Leukemia

In brief

This study is a Phase 1, open-label, dose escalation, and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-leukemic activity of WU-NK-101 in R/R AML.

Key facts

Study ID

NCT05470140

Run by

Allotera Therapeutics

People needed

9

Starts

2023-07-01

Expected to finish

2024-10-08

Last updated by the study team

2025-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of primary or secondary AML (any subtype except acute promyelocytic leukemia) according to World Health Organization (WHO) 2016 classification
• Unlikely to benefit from standard of care therapy
• 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
• Adequate organ function as defined in the protocol
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 at screening

You may not qualify if…

• Circulating blast count >30,000/µL by morphology or flow cytometry (cytoreductive therapies such as leukapheresis or hydroxyurea are allowed)
• Uncontrolled or untreated bacterial, fungal, or viral infections, including HIV, Hepatitis B or C infection, or uncontrolled infection of any etiology
• Uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiogram (ECG) suggestive of acute ischemia or active conduction system abnormalities
• Severe renal impairment, defined as creatinine clearance <40 mL/min

Where it is running

• City of Hope — Duarte, California, United States
• Stanford Healthcare — Palo Alto, California, United States
• Norton Health Care — Louisville, Kentucky, United States
• University of Maryland — Baltimore, Maryland, United States
• Washington University — St Louis, Missouri, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• Peter MacCallum Cancer Center — Melbourne, Australia
• Royal Perth Hospital — Perth, Australia
• Royal Prince Alfred Hospital — Sydney, Australia

Full record on ClinicalTrials.gov

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