NCT05470140CompletedPhase 1
A Phase 1 Study of WU-NK-101 in Patients With Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML)
Source: ClinicalTrials.gov · Last updated 30 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- First submitted
- 20 Jul 2022
- Start date
- 1 Jul 2023
- Primary completion date
- 8 Oct 2024
- Lead sponsor
- Allotera Therapeutics
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT05470140
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 9
- From 1 Jul 2023 to the primary completion date, 8 Oct 2024
- 9 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- Circulating blast count \>30,000/µL by morphology or flow cytometry (cytoreductive therapies such as leukapheresis or hydroxyurea are allowed)
- Severe renal impairment, defined as creatinine clearance \<40 mL/min
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peter MacCallum Cancer Center Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Royal Perth Hospital Coordinator of this site? Confirm its status | Perth | Australia | Unknown status |
| Royal Prince Alfred Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| University of Maryland Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Norton Health Care Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Stanford Healthcare Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| Providence Portland Medical Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.