Clinical Study of SNK01 in Participants With Moderate Alzheimer's Disease
NCT ID: NCT06189963
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
36 participants
INTERVENTIONAL
2023-11-21
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
1. Is SNK01 safe and tolerable when administered every 3 weeks for up to 1 year as an intravenous infusion
2. Can SNK01 administration improve cognitive assessment scores and biomarkers
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SNK01
SNK01 will be administered as an IV infusion Q3W for up to 1 year.
SNK01
SNK01 is a novel cell-based, patient specific ex vivo expanded autologous natural killer (NK) cell, immunotherapeutic drug
Placebo
Placebo will be administered as an IV infusion Q3W for up to 1 year.
Placebo
Sodium Lactate Hartmann's Solution
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SNK01
SNK01 is a novel cell-based, patient specific ex vivo expanded autologous natural killer (NK) cell, immunotherapeutic drug
Placebo
Sodium Lactate Hartmann's Solution
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Participants must have a reliable study partner/caregiver (per investigator judgement for instance a family member, partner etc., guardian (must be always the same person)) who is in close contact with the patient, available on call and who is able to contribute to the assessment of the ratings of the functional endpoints at specific study visits. This person will be able to communicate in the language in which the participant is being assessed and should also serve as a backup contact for the study site. The study partner/caregiver must sign a separate informed consent form which describes their contributions during the study.
3. Patients with diagnosis of Alzheimer's dementia according to the recommendations from the 2011 National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease.
4. Age 40 to 85 years old.
5. Patients must have at least 6 years of formal education and fluency in the test language as verbally confirmed by the patient or their legally authorized representative and documented by the study investigator.
6. Female participants of childbearing potential must have a negative urine pregnancy test at Screening and Visit 1 before first administration of the study drug. Females of childbearing potential are defined as those who are not surgically sterile or who are not post-menopausal (i.e.: no menses for at least 1 year). Male and female participants of reproductive potential must also agree to abstinence or use acceptable form(s) of effective contraception during the study and for 30 days after the final dose of the study drug. Acceptable methods of contraception include the following:
1. Condoms, sponges, foams, gels, diaphragms, or intrauterine device (IUD).
2. Hormonal birth control for 30 days prior to administration of the study drug.
3. A vasectomized sexual partner.
7. Positive evidence for a diagnosis of AD via amyloid positron emission tomography (Amyloid PET) of the brain within the past six months.
8. CDR-SB score of ≥ 9.5 and \<16.0.
Exclusion Criteria
2. History of a stroke/intracranial hemorrhage temporally related to the onset of worsening of cognitive impairment in the opinion of the investigator.
3. Any substance use disorder that has not been in remission for at least 12 months
4. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.
5. Uncontrolled cardiovascular illnesses such as chronic congestive heart failure (with or without oedema), tachycardia, arrhythmias, uncontrolled hypertension.
6. History of cerebrovascular accident or transient ischemic attack (TIA), or unexplainable loss of consciousness within the last year.
7. Significant pulmonary disease predisposing to hypoxia.
8. Significant ischemic heart disease, myocardial infarction within the last two years and/or with residual angina, orthopnea, conduction defects (ECG), or any other clinically significant heart disease classified as NYHA III or IV.
9. Significant liver disease (for example cirrhosis, active hepatitis B and C, primary or metastatic liver neoplasm).
10. Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening.
11. Significant gastrointestinal disorders (for example gastrointestinal bleeding within the last two years, malabsorption syndromes, post-gastrectomy, or active peptic ulcer disease).
12. Immunological disorder such as per investigator judgement clinically significant allergies, Lupus erythematodes, or scleroderma.
13. Uncontrolled/Unstable hematological disease (regardless of cause) such as refractory anemia or refractory myelosuppression.
14. Neurological disease (such as: Lewy body dementia - primary diagnosis, Huntington's disease, Parkinson's Disease, encephalitis, epilepsy, vascular or multi-infarct dementia, stroke, congenital mental deficiency, multiple sclerosis) and psychiatric disorders (such as schizophrenia, or intellectual disability), or any other disorders impacting cognitive function.
15. Unstable/uncontrolled major depression or anxiety within the last 12 months.
16. History of seizures in the past three years.
17. Uncontrolled endocrine disease such as uncontrolled diabetes mellitus or manifest hyperthyroidism, in the opinion of the investigator.
18. Severe renal impairment defined as a GFR \< 30 mL/min/1.73 m2 in the screening lab report
19. Infection with human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or any other infection or active systemic disease.
20. Currently being treated with anticoagulants (except aspirin at or below a prophylactic dose).
21. Participants who are taking medications for AD, like memantine or acetylcholinesterase inhibitors (AChEI) that exceeds the normal recommended dose range or have not achieved a stable dose for the 30 days prior to enrollment.
22. Any contraindication for performing a brain MRI and/or Amyloid PET scan.
23. Any participant whose safety the investigator considers to be at risk from this trial's intervention.
24. Participants with any medically unstable/uncontrolled conditions.
25. Any suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
26. Any suicidal ideation of type 4 or 5 in the C-SSRS in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent).
40 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NKGen Biotech, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Behavioral Research Specialists, LLC
Glendale, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
Valiance Clinical Research
Tarzana, California, United States
AdventHealth Research Institute
Orlando, Florida, United States
Ottawa Memory Clinic
Ottawa, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Harry Chung
Role: primary
Nikole Bo
Role: primary
Jesse Padilla
Role: primary
Ana Chavarro Rendon
Role: primary
Richard Bergeron, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SNK01-AD01
Identifier Type: -
Identifier Source: org_study_id