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

NCT06189963 | Recruiting Phase 1 FDA Drug

• 1 other identifier: SNK01-AD01
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 5

Brief 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. 1.Is SNK01 safe and tolerable when administered every 3 weeks for up to 1 year as an intravenous infusion
2. 2.Can SNK01 administration improve cognitive assessment scores and biomarkers

Conditions

Moderate Alzheimer Disease

Outcome Measures

Primary Outcomes (8)

• Number of participants with dose-limiting toxicity

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

  3 weeks

• 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.

  3 weeks

• 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

  1 Year

• Preliminary efficacy in cognitive assessment scores of CDR-SB

  Measure changes in cognitive assessment of CDR-SB from baseline

  1 Year

• Preliminary efficacy in cognitive assessment scores of MMSE

  Measure changes in cognitive assessment of MMSE from baseline

  1 Year

• Preliminary efficacy in cognitive assessment scores of NPI

  Measure changes in cognitive assessment of NPI from baseline

  1 Year

• Preliminary efficacy in cognitive assessment scores of ADCS-ADL-Severe

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

  1 Year

• Preliminary efficacy in cognitive assessment scores of ADAS-Cog

  Measure changes in cognitive assessment of ADAS-Cog from baseline

  1 Year

Secondary Outcomes (2)

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

  1 Year

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

  1 Year

Study Arms (2)

SNK01

EXPERIMENTAL

SNK01 will be administered as an IV infusion Q3W for up to 1 year.

Biological: SNK01

Placebo

PLACEBO COMPARATOR

Placebo will be administered as an IV infusion Q3W for up to 1 year.

Other: Placebo

Interventions

SNK01 BIOLOGICAL

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

SNK01

Placebo OTHER

Sodium Lactate Hartmann's Solution

Placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• NKGen Biotech, Inc.: lead

Study Sites (5)

Behavioral Research Specialists, LLC

Glendale, California, 91206, United States

RECRUITING

Syrentis Clinical Research

Santa Ana, California, 92705, United States

RECRUITING

Valiance Clinical Research

Tarzana, California, 91356, United States

RECRUITING

AdventHealth Research Institute

Orlando, Florida, 32804, United States

RECRUITING

Ottawa Memory Clinic

Ottawa, Ontario, K1Z 1G3, Canada

NOT YET RECRUITING

Central Study Contacts

Study Director

CONTACT

949-396-6830; trials@nkgenbiotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: January 5, 2024
• Study Start: November 21, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); CA (1)