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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Clinical Study of SNK01 in Participants With Moderate Alzheimer's Disease

A Phase I/IIa, Study to Evaluate the Safety, Tolerability and Exploratory Efficacy of SNK01 in Participants With Moderate Alzheimer's Disease

Clinical Study of SNK01 in Participants With Moderate Alzheimer's Disease (NCT06189963) is a Phase 1 / Phase 2 interventional studying Moderate Alzheimer Disease, sponsored by NKGen Biotech, Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The goal of this clinical trial is to test SNK01 in participants with moderate Alzheimer's Disease. The main questions it aims to answer are: 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

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Moderate Alzheimer Disease, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 36 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. The participant or their legally authorized representative must be willing and able to give their willing to sign a consent form in writing and comply with the requirements of this study protocol. willing to sign a consent form for participants or their legally authorized representative and caregivers will be obtained before any trial-related activity. (Trial-related activities are any procedure that would not be performed during normal treatment of the participant). 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 willing to sign a consent form 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. The participant or their legally authorized representative must be willing and able to give their informed consent in writing and comply with the requirements of this study protocol. Informed consent for participants or their legally authorized representative and caregivers will be obtained before any trial-related activity. (Trial-related activities are any procedure that would not be performed during normal treatment of the participant). 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: 1. Substantial concomitant cerebrovascular disease defined as Fazekas Grade 3. 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).

Treatments Being Tested

BIOLOGICAL

SNK01

SNK01 is a novel cell-based, patient specific ex vivo expanded autologous natural killer (NK) cell, immunotherapeutic drug

OTHER

Placebo

Sodium Lactate Hartmann's Solution

Locations (5)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06189963), the sponsor (NKGen Biotech, Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06189963 clinical trial studying?

The goal of this clinical trial is to test SNK01 in participants with moderate Alzheimer's Disease. The main questions it aims to answer are: 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 The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06189963?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06189963?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06189963. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06189963. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.