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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05470140




Registration number
NCT05470140
Ethics application status
Date submitted
20/07/2022
Date registered
22/07/2022
Date last updated
7/09/2023

Titles & IDs
Public title
A Phase 1 Study of WU-NK-101 in Patients With Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML)
Scientific title
A Phase 1 Study of WU-NK-101 in Patients With Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML)
Secondary ID [1] 0 0
WUN101-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - WU-NK-101

Experimental: Experimental: WU-NK-101 - 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.


Other interventions: WU-NK-101
WU-NK-101 administered on Day 1, Day 8, and Day 15.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Adverse Events of WU-NK-101 as assessed by CTCAE v5
Timepoint [1] 0 0
24 months
Primary outcome [2] 0 0
Maximum Tolerated Dose
Timepoint [2] 0 0
Up to 21 days from first dose
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
3 months
Secondary outcome [2] 0 0
Duration of Response
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
Overall Response Rate (ORR)
Timepoint [3] 0 0
24 months

Eligibility
Key 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 defined by any one of the following
criteria:

1. Primary induction failure (PIF) defined as leukemia refractory to = 1 induction
attempts. Induction attempts include 1 high-dose and/or 2 standard-dose
cytarabine

- an anthracyclines/anthracenedione ± an anti-metabolite, with or without
growth factor or targeted therapy containing regimens.

2. For adults who are age 75 years or older, or who have comorbidities that preclude
use of intensive induction chemotherapy; PIF is defined as AML refractory to one
of the following less intensive regimens:

- = 2 but = 4 cycles of Bcl-2 inhibitors in combination with azacitidine,
decitabine, or low dose cytarabine

- = 2 but = 4 cycles of gemtuzumab ozogamicin monotherapy

- = 6 but = 8 cycles ivosidenib or enasidenib

3. Leukemia in relapse after achieving CR

- Early Relapse: disease recurrent within = 6 month of documented remission

- Late Relapse: disease recurrent within > 6 month of documented remission

- Refractory-Relapse: refractory to = 1 unsuccessful salvage attempts

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 with the exception
of physiologic doses (<10 mg) of corticosteroids

- No history of Grade = 3 veno-occlusive disease, or active graft versus host
disease

4. Patients with known central nervous system (CNS) involvement with AML are eligible if
they have been treated and cerebrospinal fluid is clear for at least 2 weeks prior to
enrollment into the study. CNS therapy (radiotherapy or chemotherapy) should continue
as medically indicated during the study treatment.

5. Patients with extramedullary disease are permitted if bone marrow blast count is >5%

6. Adequate organ function as defined in the protocol

7. Life expectancy >12 weeks

8. Eastern Cooperative Oncology Group (ECOG) Performance Status = 2 at screening
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

5. New progressive pulmonary infiltrates on screening chest x-ray or chest CT scan that
have not been evaluated with bronchoscopy. Infiltrates attributed to infection must be
stable/improving after 1 week of appropriate therapy (4 weeks for presumed or proven
fungal infections).

6. Known hypersensitivity to one or more of the study agents

7. Received any investigational drugs within the 14 days prior to the first dose of
fludarabine (wash-out period of at least 5 half-lives from the last dose of any
investigational therapy prior to screening period or 14 days, whichever is longer)

8. Pregnant or nursing (lactating) women

9. Any condition that, in the opinion of the Investigator, would prevent the participant
from consenting to or participating in the study

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Center - Melbourne
Recruitment hospital [2] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [3] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment postcode(s) [2] 0 0
- Perth
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Kentucky
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
Oregon

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Wugen, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05470140
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jan Davidson, MD, PhD
Address 0 0
Wugen, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Eileen McNulty
Address 0 0
Country 0 0
Phone 0 0
314-501-1968
Fax 0 0
Email 0 0
info@wugen.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05470140