9 Participants Needed

WU-NK-101 for Acute Myeloid Leukemia

Recruiting at 8 trial locations
EM
Overseen ByEileen McNulty
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Wugen, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

CT

Cherry Thomas, MD

Principal Investigator

Wugen, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with Acute Myeloid Leukemia (AML) that has returned after treatment or hasn't responded to previous treatments. Participants should have had a stem cell transplant over 90 days ago, no severe organ disease, and an ECOG Performance Status of ≤2. They can't join if they have severe kidney issues, high blast counts without reduction therapy, uncontrolled infections or heart problems, recent investigational drug use, known allergies to study drugs, or are pregnant/nursing.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.
Life expectancy >12 weeks
My condition is a type of leukemia, but not acute promyelocytic leukemia.
See 6 more

Exclusion Criteria

My recent lung scans show new worsening spots.
Known hypersensitivity to one or more of the study agents
Circulating blast count >30,000/µL by morphology or flow cytometry
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive WU-NK-101 in up to 3 Dose Levels until maximum tolerated dose or maximum administered dose is determined

Up to 21 days
3 visits (in-person) per 28-day cycle

Cohort Expansion

Further characterization of safety and tolerability, and determination of recommended phase 2 dose

Up to 4 cycles of 28 days each
3 visits (in-person) per 28-day cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • WU-NK-101
Trial Overview The trial tests WU-NK-101's safety and effectiveness in treating AML that's come back or isn't responding to other treatments. It's an early-phase study where researchers gradually increase the dose to find the safest amount that works while monitoring how it affects the body and leukemia.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Experimental: WU-NK-101Experimental Treatment1 Intervention

WU-NK-101 is already approved in United States for the following indications:

🇺🇸
Approved in United States as WU-NK-101 for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wugen, Inc.

Lead Sponsor

Trials
8
Recruited
400+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security