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Moderate Alzheimer DiseasePhase 1/2NCT06189963

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

A Phase 1/2 study testing SNK01 in people with Moderate Alzheimer Disease, run by NKGen Biotech, Inc. at 8 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
Moderate Alzheimer Disease
What is being tested?
SNK01
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
8 sitesin 2 countries
Study dates
21 Nov 2023to Jun 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
  • 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.
  • 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.
  • Age 40 to 85 years old.
  • 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.
  • 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:
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  • Condoms, sponges, foams, gels, diaphragms, or intrauterine device (IUD).
  • Hormonal birth control for 30 days prior to administration of the study drug.
  • A vasectomized sexual partner.
  • Positive evidence for a diagnosis of AD via amyloid positron emission tomography (Amyloid PET) of the brain within the past six months.
  • CDR-SB score of ≥ 9.5 and <16.0.

Who cannot join

  • Substantial concomitant cerebrovascular disease defined as Fazekas Grade 3.
  • History of a stroke/intracranial hemorrhage temporally related to the onset of worsening of cognitive impairment in the opinion of the investigator.
  • Any substance use disorder that has not been in remission for at least 12 months
  • Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.
  • Uncontrolled cardiovascular illnesses such as chronic congestive heart failure (with or without oedema), tachycardia, arrhythmias, uncontrolled hypertension.
  • History of cerebrovascular accident or transient ischemic attack (TIA), or unexplainable loss of consciousness within the last year.
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  • Significant pulmonary disease predisposing to hypoxia.
  • 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.
  • Significant liver disease (for example cirrhosis, active hepatitis B and C, primary or metastatic liver neoplasm).
  • 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.
  • Significant gastrointestinal disorders (for example gastrointestinal bleeding within the last two years, malabsorption syndromes, post-gastrectomy, or active peptic ulcer disease).
  • Immunological disorder such as per investigator judgement clinically significant allergies, Lupus erythematodes, or scleroderma.
  • Uncontrolled/Unstable hematological disease (regardless of cause) such as refractory anemia or refractory myelosuppression.
  • 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.
  • Unstable/uncontrolled major depression or anxiety within the last 12 months.
  • History of seizures in the past three years.
  • Uncontrolled endocrine disease such as uncontrolled diabetes mellitus or manifest hyperthyroidism, in the opinion of the investigator.
  • Severe renal impairment defined as a GFR < 30 mL/min/1.73 m2 in the screening lab report
  • Infection with human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or any other infection or active systemic disease.
  • Currently being treated with anticoagulants (except aspirin at or below a prophylactic dose).
  • 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.
  • Any contraindication for performing a brain MRI and/or Amyloid PET scan.
  • Any participant whose safety the investigator considers to be at risk from this trial's intervention.
  • Participants with any medically unstable/uncontrolled conditions.
  • Any suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
  • 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).

Trial locations and contacts

8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Study Director contact

949-396-6830

trials@nkgenbiotech.com

8 sites in 2 countries

United States7 sites, 6 recruiting

  • Alzheimer's Disease Research Center

    Albany, New York, 12208

    Laura Wang, 518-426-0575, lwang@naaresearch.com

    Recruiting

  • Behavioral Research Specialists, LLC

    Glendale, California, 91206

    Harry Chung, (888) 255-5798, harry@brstrials.com

    Recruiting

  • K2 Medical Research

    Maitland, Florida, 32751

    Adaliz Rodriguez, 407-500-5252, adaliz.rodriguez@k2med.com

    Recruiting

  • Rutgers Health

    Newark, New Jersey, 07107

    Kelly Saverino, 973-972-1268, kcs143@njms.rutgers.edu

    Recruiting

  • AdventHealth Research Institute

    Orlando, Florida, 32804

    Ana Chavarro Rendon, 407-609-9040, cfd-sneuroscienceresearch@adventhealth.com

    Recruiting

  • Syrentis Clinical Research

    Santa Ana, California, 92705

    Nikole Bo, 714-542-3008, nbo@syrentis.com

    Recruiting

  • Valiance Clinical Research

    Tarzana, California, 91356

    Withdrawn

Other trials in United States

Canada1 site

  • Ottawa Memory Clinic

    Ottawa, Ontario, K1Z 1G3

    Withdrawn

Other trials in Canada

About this study

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

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
Being tested
SNK01, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SNK01Biological

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

  • PlaceboOther

    Sodium Lactate Hartmann's Solution

Study groups in NCT06189963
Study groupRoleWhat they receive
SNK01ExperimentalSNK01 will be administered as an IV infusion Q3W for up to 1 year.
Receives: Biological: SNK01
PlaceboPlacebo comparatorPlacebo will be administered as an IV infusion Q3W for up to 1 year.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with dose-limiting toxicity

    DLTs will be assessed by the review of labs, PE and AEs

    Measured: 3 weeks

  2. Maximum tolerated dose determination

    Determine the maximum tolerated dose based on the evaluation of the number of participants who experience a DLT which will then determine the RP2D.

    Measured: 3 weeks

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Evaluate the safety and tolerability of SNK01 assessed by labs, PE and AEs

    Measured: 1 Year

  4. Preliminary efficacy in cognitive assessment scores of CDR-SB

    Measure changes in cognitive assessment of CDR-SB from baseline

    Measured: 1 Year

  5. Preliminary efficacy in cognitive assessment scores of MMSE

    Measure changes in cognitive assessment of MMSE from baseline

    Measured: 1 Year

  6. Preliminary efficacy in cognitive assessment scores of NPI

    Measure changes in cognitive assessment of NPI from baseline

    Measured: 1 Year

  7. Preliminary efficacy in cognitive assessment scores of ADCS-ADL-Severe

    Measure changes in cognitive assessment of ADCS-ADL-Severe from baseline

    Measured: 1 Year

  8. Preliminary efficacy in cognitive assessment scores of ADAS-Cog

    Measure changes in cognitive assessment of ADAS-Cog from baseline

    Measured: 1 Year

Secondary outcomes (2)

  1. Changes in CSF biomarkers (pTau 181, Aβ42/40, GFAP, NfL)

    Measure changes in CSF biomarkers as changed from baseline

    Measured: 1 Year

  2. Changes in plasma biomarkers (pTau 181, Aβ42/40, GFAP, NfL)

    Measure changes in Plasma biomarkers as changed from baseline

    Measured: 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2024
  2. Study start21 Nov 2023
  3. Primary completionMar 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06189963
Sponsor's protocol ID
SNK01-AD01
Status last verified
Sep 2026
First submitted
6 Dec 2023
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SNK01 in people with Moderate Alzheimer Disease, run by NKGen Biotech, Inc. at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Director (949-396-6830, trials@nkgenbiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with dose-limiting toxicity (time frame: 3 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06189963.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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