CompletedPhase 1

A Phase 1 Study of WU-NK-101 in Patients With Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML)

United States9 participantsStarted 2023-07-01

Plain-language summary

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 can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Confirmed diagnosis of primary or secondary AML (any subtype except acute promyelocytic leukemia) according to World Health Organization (WHO) 2016 classification
✓. Unlikely to benefit from standard of care therapy
✓. Patients with AML post hematopoietic stem cell transplant (HSCT) \[permitted in Cohort Expansion Phase only\] must meet the following criteria:
✓. Adequate organ function as defined in the protocol
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 at screening

Exclusion criteria

✕. Circulating blast count \>30,000/µL by morphology or flow cytometry (cytoreductive therapies such as leukapheresis or hydroxyurea are allowed)
✕. Uncontrolled or untreated bacterial, fungal, or viral infections, including HIV, Hepatitis B or C infection, or uncontrolled infection of any etiology
✕. Uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiogram (ECG) suggestive of acute ischemia or active conduction system abnormalities
✕. Severe renal impairment, defined as creatinine clearance \<40 mL/min

What they're measuring

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

Timeframe: 24 months

Maximum Tolerated Dose

Timeframe: Up to 21 days from first dose

Trial details

NCT IDNCT05470140

SponsorWugen, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-08

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