WU-NK-101 for Acute Myeloid Leukemia

Phase 1

Waitlist Available

Research Sponsored by Wugen, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug to fight acute myeloid leukemia in adults. It looks at safety, how it works, and if it's effective.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of WU-NK-101 aren't listed here as it’s a new treatment under investigation, common side effects for similar leukemia therapies may include fatigue, fever, nausea and vomiting; potential risks will be closely monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Adverse Events of WU-NK-101 as assessed by CTCAE v5

Maximum Tolerated Dose

Secondary study objectives

Duration of Response

Overall Response Rate (ORR)

Overall Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental: WU-NK-101Experimental Treatment1 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.

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