Clinical trial · Interventional
A Phase 1 Study of WU-NK-101 in Patients With Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML)
NCT05470140CI-TRIAL-00096022completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| WU-NK-101 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: WU-NK-101
- description
- 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.
- interventionNames
- Biological: WU-NK-101
Primary outcomes (2)
- measure
- Incidence of Adverse Events of WU-NK-101 as assessed by CTCAE v5
- timeFrame
- 24 months
- description
- Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of consent until End of Study (EOS) visit.
- measure
- Maximum Tolerated Dose
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Confirmed diagnosis of primary or secondary AML (any subtype except acute promyelocytic leukemia) according to World Health Organization (WHO) 2016 classification 2. Unlikely to benefit from standard of care therapy 3. Patients with AML post hematopoietic stem cell transplant (HSCT) \[permitted in Cohort Expansion Phase only\] must meet the following criteria: * There must be histological confirmation of AML relapse after HSCT * Undergone allogeneic HSCT (alloSCT) \> 90 days prior to enrollment from a match related donor, matched unrelated donor, cord blood donor, or haplo- identical donor * Off all immunosuppressive medications for a minimum of 2 weeks 4. Adequate organ function as defined in the protocol 5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 at screening Exclusion Criteria: 1. Circulating blast count \>30,000/µL by morphology or flow cytometry (cytoreductive therapies such as leukapheresis or hydroxyurea are allowed) 2. Uncontrolled or untreated bacterial, fungal, or viral infections, including HIV, Hepatitis B or C infection, or uncontrolled infection of any etiology 3. Uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiogram (ECG) suggestive of acute ischemia or active conduction system abnormalities 4. Severe renal impairment, defined as creatinine clearance \<40 mL/min
References
Publications (0)
Data not yet available
No reference posted for this study.