WU-NK-101 for Acute Myeloid Leukemia

Recruiting at 8 trial locations

Overseen By Eileen McNulty

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Wugen, Inc.

Disqualifiers: Infections, Severe renal impairment, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

9 Participants Needed

Trial Summary

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.

Research Team

Cherry Thomas, MD

Principal Investigator

Wugen, Inc.

Eligibility Criteria

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.

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

Treatment Details

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.

Participant Groups

Group I: Experimental: WU-NK-101 Experimental Treatment 1 Intervention

A non-engineered Natural Killer (NK) cell derived from peripheral blood mononuclear cells (PBMC) that is cytokine-reprogrammed, expanded, and cryopreserved to create an allogeneic enhanced Memory-like anti-tumor NK cell therapy product. Each 28-day cycle of treatment consists of 3 doses of WU-NK-101 administered on Day 1, Day 8, and Day 15.

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

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

• Acute Myeloid Leukemia (AML) - Orphan Drug Designation

Who Is Running the Clinical Trial?

Wugen, Inc.

Lead Sponsor

Trials

8

Recruited

400+