WU-NK-101 for Acute Myeloid Leukemia

No longer recruiting at 9 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: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called WU-NK-101 for individuals with acute myeloid leukemia (AML), a type of blood cancer. The researchers aim to determine if this treatment is safe, tolerable, and effective in fighting the cancer. WU-NK-101 employs special natural killer cells designed to attack cancer cells. Suitable candidates for this trial have a confirmed AML diagnosis, have not responded to standard treatments, and manage well day-to-day without severe organ issues. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. However, if you are on immunosuppressive medications, you must be off them for at least 2 weeks before joining the trial.

Is there any evidence suggesting that WU-NK-101 is likely to be safe for humans?

Research has shown that WU-NK-101, a type of natural killer (NK) cell therapy, may help treat cancer. Early studies suggest these memory NK cells are safe and effective. Memory NK cells are special immune cells that remember how to fight cancer better than regular NK cells.

Regarding safety, earlier research indicates that patients have tolerated the treatment well, with no major safety issues reported. The treatment is made from healthy donor cells and can be given to any patient without needing a match, which lowers some risks. However, since this is a Phase 1 trial, the main goal is to learn more about its safety and patient tolerance.

For those considering joining the trial, early evidence suggests it is safe, but more information will become available as the trial continues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard chemotherapy treatments for Acute Myeloid Leukemia (AML), like cytarabine and daunorubicin, WU-NK-101 uses a groundbreaking approach by harnessing the power of natural killer (NK) cells. This treatment consists of NK cells that are reprogrammed and expanded to enhance their memory-like ability to target and destroy cancer cells. Researchers are excited about WU-NK-101 because it represents a shift from traditional methods by potentially offering a more targeted and potent attack against leukemia cells, with the possibility of fewer side effects compared to conventional chemotherapy.

What evidence suggests that WU-NK-101 might be an effective treatment for acute myeloid leukemia?

Research shows that WU-NK-101, the investigational treatment in this trial, could help fight acute myeloid leukemia (AML). Studies have found that these cells effectively locate and destroy AML cells. They excel at reaching the bone marrow, where leukemia often hides. WU-NK-101 also performs well in challenging conditions, such as low oxygen and limited nutrients, suggesting it might remain effective in the body's difficult environments. Early findings indicate that WU-NK-101 continues to develop into a strong and active fighter against leukemia as it expands in patients. ^{1 2 5 6 7}

Who Is on the Research Team?

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.

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

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?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9429392/

WU-NK-101, AN ALLOGENEIC MEMORY NK CELL, FOR ... Pre-clinically, WU-NK-101 displayed improved homing to the BM, resistance to an adverse and immunosuppressive TME, and activity against AML cell lines both in ...

2. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/4257/533531/WUN101-01-First-in-Human-Human-FIH-Phase-1-Study

First in Human Human (FIH) Phase 1 Study of WU-NK-101 (W ... These data suggest that W-NK1 continues to mature into a functionally competent and cytotoxic effector cell as it expands in AML patients.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S000649712305070X

WU-NK-101 (W-NK), a Memory-like (ML) NK Cell ... In summary, W-NK are effective against AML cells, robustly home to the BM, overcome hypoxia, immunosuppression, and nutritional scarcity to ...

4. wugen.com wugen.com/wugen-to-present-new-clinical-data-for-wu-cart-007-and-preclinical-data-for-wu-nk-101-two-investigational-allogeneic-cell-therapies-for-challenging-hematologic-cancers-at-american-society-of-hematol/

Wugen to Present New Clinical Data for WU-CART-007 ... WU-NK-101 is currently in development for acute myelogenous leukemia (AML). Wugen is planning to initiate solid tumor studies of WU-NK-101 in ...

5. clin.larvol.com clin.larvol.com/trial-detail/NCT05470140

A Phase 1 Study of WU-NK-101 in Patients With Relapsed ... Compared to cNK cells, WU-NK-101 had enhanced anti-tumor activity, trafficked to the bone marrow, and showed metabolic flexibility, potentially mitigating the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10429044/

PB2498: A PHASE 1 STUDY OF WU-NK-101 IN PATIENTS ... Response rate, duration of response, and mortality rate at 1 and 3 months will be evaluated. Keywords: Clinical trial, Cellular therapy, NK cell, Acute myeloid ...

7. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/466/504291/WU-NK-101-W-NK-a-Memory-like-ML-NK-Cell

WU-NK-101 (W-NK), a Memory-like (ML) NK Cell, Intrinsically ... WU-NK-101 (W-NK), a memory-like (ML) NK cell, intrinsically overcomes factors restricting adoptive cell therapy (ACT) in acute myeloid leukemia (AML).