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New immune therapy shows promise in early leukemia trial

NCT ID NCT05470140

Disease control Sponsor: Wugen, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tested a new treatment called WU-NK-101 in 9 adults with acute myeloid leukemia (AML) that returned or didn't respond to standard therapy. The goal was to check safety and find the best dose. Participants received immune cells designed to attack cancer. This is not a cure, but aims to control the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

9 people

The number who actually took part.

Started

Jul 2023

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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 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 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 (cytoreductive therapies 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, or electrocardiogram (ECG) suggestive of acute ischemia or active conduction system abnormalities 4. Severe renal impairment, defined as creatinine clearance \<40 mL/min

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia leukemia Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia

Contacts and locations

Locations

  • City of Hope

    Duarte, California, 91010, United States

  • Norton Health Care

    Louisville, Kentucky, 40299, United States

  • Peter MacCallum Cancer Center

    Melbourne, Australia

  • Providence Portland Medical Center

    Portland, Oregon, 97213, United States

  • Royal Perth Hospital

    Perth, Australia

  • Royal Prince Alfred Hospital

    Sydney, Australia

  • Stanford Healthcare

    Palo Alto, California, 94304, United States

  • University of Maryland

    Baltimore, Maryland, 21201, United States

  • Washington University

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.