Alzheimer DiseasePhase 1ASK-ADNCT04678453
Safety of SNK01 in Subjects With Alzheimer's Disease (ASK-AD)
A Phase 1 study testing SNK01 in people with Alzheimer Disease and Neuro-Degenerative Disease, run by NKGen Biotech, Inc. at 1 site in Mexico.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of SNK01 (autologous natural killer cell), as a single agent, for the treatment of subjects with Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer Disease, Neuro-Degenerative Disease
- What is being tested?
- SNK01
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteMexico
- Study dates
- 6 Jan 2021to 31 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and protocol. If the subject is incapable of giving or signing informed consent, the subject must have a legally authorized representative willing to consent on their behalf.
- Subject must be ≥ 55 to 85 years old at the time of consent.
- Magnetic resonance imaging (MRI) scans of the brain within the past six months reveal evidence and findings consistent with Alzheimer's disease, including hippocampal volume loss and/or overall cerebral atrophy (cerebral volume loss).
- Fluorodeoxyglucose-positron emission tomography (FDG-PET) scans of the brain within the past six months reveal evidence and findings consistent with mild cognitive impairment or Alzheimer's disease.
- Subject presenting, during evaluation by the study Investigator, to have spontaneous memory loss or presenting abnormal memory function in early screening.
- Subject must be in good health with adequate hearing and vision.
- Subject must have a reliable caregiver.
- Women of childbearing potential who are not abstinent and intend to be sexually active with a nonsterilized male partner must be willing to use an adequate method of contraception throughout the study and for one month following the last day of the last administration of final study drug dose. Acceptable methods include hormonal contraception (oral contraceptives [taken 90 days prior to administration of study drug], intrauterine devices (IUD), or double barrier methods (e.g., vaginal diaphragm/vaginal sponge plus condoms, or condom plus spermicidal jelly), sexual abstinence, or a vasectomized partner.
Who cannot join
- Any medical or neurological conditions, other than Alzheimer's disease, that could contribute to the cause of cognitive impairment in the subject. Examples include, but are not limited to, frontotemporal dementia (FTD), Lewy body dementia, vascular dementia, Parkinson's disease, corticobasal degeneration, Creutzfeldt-Jakob disease, progressive supranuclear palsy, Huntington's disease, normal pressure hydrocephalus, seizure disorders or cerebral hypoxia, post-traumatic stress disorder (PTSD), or alcohol or medication use or abuse.
- Subject does not present with signs of mild cognitive impairment or Alzheimer's disease at screening, or during evaluation by the study Investigator.
- Subject presents with significant brain disease including hemorrhage or infarction.
- Subject has a history of cerebrovascular accident or transient ischemic attack (TIA), or unexplainable loss of consciousness during the past year.
- Subject has a history of schizophrenia, schizoaffective disorder, major depressive disorder (MDD), bipolar disorder, or any other clinically relevant psychiatric disease.
- Subject has a history of seizure episodes within the past three years.
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- Subject has uncontrolled diabetes mellitus.
- Subject has a history of unstable angina, myocardial infarction, chronic heart failure, or clinically relevant conduction abnormalities within the year prior to screening.
- Subject suffers from renal or hepatic failure.
- Subject is infected with the human immunodeficiency virus (HIV), Hepatitis B (Hep B), Hepatitis C (Hep C), or any other infection or active systemic disease.
- Subject is using anticoagulants (except aspirin at or below a prophylactic dose).
- Subject is currently exceeding the normal recommended dosage for any drug used to treat Alzheimer's disease (e.g., memantine or acetylcholinesterase inhibitors [AChEI]).
- Subject has contraindication to MRI scans, FDG-PET scans, or lumbar spinal taps.
- Subject whose safety is considered to be at risk from trial's intervention, as determined by the study Investigator.
- Pregnant or lactating female subjects.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Angeles Tijuana
Tijuana, Estado de Baja California, 22010
About this study
Official title: Single Center, Open Label, Phase 1 Study to Evaluate the Safety, Tolerability and Exploratory Efficacy of SNK01 in Subjects With Alzheimer's Disease (AD)
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of SNK01 (autologous natural killer cell), as a single agent, for the treatment of subjects with Alzheimer's disease.
- Conditions
- Alzheimer Disease, Neuro-Degenerative Disease
- Being tested
- SNK01
- Keywords
- Natural killer cell, NK cell, Expanded natural killer cell, Alzheimer's Disease, Neurodegenerative diseases, Neurocognitive disorders, Brain diseases, Autologous natural killer cell
- Medical subject headings
- Alzheimer Disease, Neurodegenerative Diseases, Neurocognitive Disorders, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNK01Biological
Patient-specific ex vivo expanded autologous natural killer cells
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - Low dose SNK01 | Experimental | SNK01 (low dose) administered once every three weeks (Q3W) for four cycles. Receives: Biological: SNK01 |
| Cohort 2 - Medium dose SNK01 | Experimental | SNK01 (medium dose) administered Q3W for four cycles. Receives: Biological: SNK01 |
| Cohort 3 - High dose SNK01 | Experimental | SNK01 (high dose) administered Q3W for four cycles. Receives: Biological: SNK01 |
| Cohort 4 - SNK01 at Maximum Tolerated Dose (MTD) / Recommended Phase 2 Dose (RP2D) | Experimental | SNK01 (at MTD/RP2D) administered Q3W for four cycles. Receives: Biological: SNK01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety profile of SNK01 monotherapy in patients with mild cognitive impairment (MCI) or Alzheimer's Disease by monitoring for adverse events.
Evaluated by the number of treatment emergent adverse event (TEAE) Grade 3 or higher considered to be related to SNK01, adverse events (AEs) of Grade 3 or higher using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v5.0, measurements of vital signs, clinical laboratory tests and physical examination.
Measured: Up to 6 months
To determine the tolerability of SNK01 monotherapy in patients with mild cognitive impairment (MCI) or Alzheimer's Disease by monitoring for adverse events.
Evaluated by the number of treatment emergent adverse event (TEAE) Grade 3 or higher considered to be related to SNK01, adverse events (AEs) of Grade 3 or higher using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v5.0, measurements of vital signs, clinical laboratory tests and physical examination.
Measured: Up to 6 months
To determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of SNK01 monotherapy.
Assessed by the incidence of dose-limiting toxicities, defined by treatment emergent adverse event (TEAE) Grade 3 or higher considered to be related to SNK01, in each dose level.
Measured: Up to 6 months
Secondary outcomes (5)
To assess preliminary efficacy of SNK01 measured by Alzheimer's Disease Assessment Scale Cognitive subscale (ADAS-Cog).
Measured: Baseline, Week 11, End of Study (Week 22)
To assess preliminary efficacy of SNK01 measured by Mini-Mental Status Exam (MMSE).
Measured: Baseline, Week 11, End of Study (Week 22)
To assess preliminary efficacy of SNK01 measured by Clinical Dementia Rating Scale: Sum of Boxes (CDR-SB).
Measured: Baseline, Week 11, End of Study (Week 22)
To assess preliminary efficacy of SNK01 measured by Alzheimer's Disease Composite Score (ADCOMS).
Measured: Baseline, Week 11, End of Study (Week 22)
To assess preliminary efficacy of SNK01 measured by cerebrospinal fluid (CSF) biomarkers: amyloid beta 42, T-tau and P-tau.
Measured: Baseline, Week 11, End of Study (Week 22)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start6 Jan 2021
- Primary completion16 Aug 2023
- Study completion31 Jan 2024
Why it stopped: The study was terminated after completing the dose escalation portion of the study. The expansion cohort was not initiated to conduct a global trial based on the approved US IND using a new manufacturing process.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- NKGen Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clemente Humberto Zúñiga Gil, MD, Principal investigator, Hospital Angeles Tijuana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678453
- Sponsor's protocol ID
- SNK01-MX04
- Acronym
- ASK-AD
- Status last verified
- Mar 2023
- First submitted
- 9 Dec 2020
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Zuniga CH, Acosta BI, Menchaca R, Amescua CA, Hong S, Hui L, Gil M, Rhee YH, Yoon S, Kim M, Chang PY, Kim YM, Song PY, Betito K. Treatment of Alzheimer's Disease subjects with expanded non-genetically modified autologous natural killer cells (SNK01): a phase I study. Alzheimers Res Ther. 2025 Feb 12;17(1):40. doi: 10.1186/s13195-025-01681-2.
PubMed 39939891
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center, Open Label, Phase 1 Study to Evaluate the Safety, Tolerability and Exploratory Efficacy of SNK01 in Subjects With Alzheimer's Disease (AD)
- ClinicalTrials.gov ID
- NCT04678453
- Acronym / sponsor ID
- ASK-AD / SNK01-MX04
- Conditions
- Alzheimer Disease, Neuro-Degenerative Disease
- Keywords
- Natural killer cell, NK cell, Expanded natural killer cell, Alzheimer's Disease, Neurodegenerative diseases, Neurocognitive disorders, Brain diseases, Autologous natural killer cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated after completing the dose escalation portion of the study. The expansion cohort was not initiated to conduct a global trial based on the approved US IND using a new manufacturing process.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- NKGen Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 16 Aug 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of SNK01 (autologous natural killer cell), as a single agent, for the treatment of subjects with Alzheimer's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Low dose SNK01 | Experimental | Biological: SNK01SNK01 (low dose) administered once every three weeks (Q3W) for four cycles. |
| Cohort 2 - Medium dose SNK01 | Experimental | Biological: SNK01SNK01 (medium dose) administered Q3W for four cycles. |
| Cohort 3 - High dose SNK01 | Experimental | Biological: SNK01SNK01 (high dose) administered Q3W for four cycles. |
| Cohort 4 - SNK01 at Maximum Tolerated Dose (MTD) / Recommended Phase 2 Dose (RP2D) | Experimental | Biological: SNK01SNK01 (at MTD/RP2D) administered Q3W for four cycles. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and protocol. If the subject is incapable of giving or signing informed consent, the subject must have a legally authorized representative willing to consent on their behalf.
- Subject must be ≥ 55 to 85 years old at the time of consent.
- Magnetic resonance imaging (MRI) scans of the brain within the past six months reveal evidence and findings consistent with Alzheimer's disease, including hippocampal volume loss and/or overall cerebral atrophy (cerebral volume loss).
- Fluorodeoxyglucose-positron emission tomography (FDG-PET) scans of the brain within the past six months reveal evidence and findings consistent with mild cognitive impairment or Alzheimer's disease.
- Subject presenting, during evaluation by the study Investigator, to have spontaneous memory loss or presenting abnormal memory function in early screening.
Key exclusion criteria (15 listed)
- Any medical or neurological conditions, other than Alzheimer's disease, that could contribute to the cause of cognitive impairment in the subject. Examples include, but are not limited to, frontotemporal dementia (FTD), Lewy body dementia, vascular dementia, Parkinson's disease, corticobasal degeneration, Creutzfeldt-Jakob disease, progressive supranuclear palsy, Huntington's disease, normal pressure hydrocephalus, seizure disorders or cerebral hypoxia, post-traumatic stress disorder (PTSD), or alcohol or medication use or abuse.
- Subject does not present with signs of mild cognitive impairment or Alzheimer's disease at screening, or during evaluation by the study Investigator.
- Subject presents with significant brain disease including hemorrhage or infarction.
- Subject has a history of cerebrovascular accident or transient ischemic attack (TIA), or unexplainable loss of consciousness during the past year.
- Subject has a history of schizophrenia, schizoaffective disorder, major depressive disorder (MDD), bipolar disorder, or any other clinically relevant psychiatric disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNK01Patient-specific ex vivo expanded autologous natural killer cells | Biological | Cohort 1 - Low dose SNK01, Cohort 2 - Medium dose SNK01, Cohort 3 - High dose SNK01, Cohort 4 - SNK01 at Maximum Tolerated Dose (MTD) / Recommended Phase 2 Dose (RP2D) |
Primary outcome
To determine the safety profile of SNK01 monotherapy in patients with mild cognitive impairment (MCI) or Alzheimer's Disease by monitoring for adverse events.
Time frame: Up to 6 months
Evaluated by the number of treatment emergent adverse event (TEAE) Grade 3 or higher considered to be related to SNK01, adverse events (AEs) of Grade 3 or higher using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v5.0, measurements of vital signs, clinical laboratory tests and physical examination.
To determine the tolerability of SNK01 monotherapy in patients with mild cognitive impairment (MCI) or Alzheimer's Disease by monitoring for adverse events.
Time frame: Up to 6 months
Evaluated by the number of treatment emergent adverse event (TEAE) Grade 3 or higher considered to be related to SNK01, adverse events (AEs) of Grade 3 or higher using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v5.0, measurements of vital signs, clinical laboratory tests and physical examination.
To determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of SNK01 monotherapy.
Time frame: Up to 6 months
Assessed by the incidence of dose-limiting toxicities, defined by treatment emergent adverse event (TEAE) Grade 3 or higher considered to be related to SNK01, in each dose level.
5 secondary outcomes
To assess preliminary efficacy of SNK01 measured by Alzheimer's Disease Assessment Scale Cognitive subscale (ADAS-Cog).
Time frame: Baseline, Week 11, End of Study (Week 22)
To assess preliminary efficacy of SNK01 measured by Mini-Mental Status Exam (MMSE).
Time frame: Baseline, Week 11, End of Study (Week 22)
To assess preliminary efficacy of SNK01 measured by Clinical Dementia Rating Scale: Sum of Boxes (CDR-SB).
Time frame: Baseline, Week 11, End of Study (Week 22)
To assess preliminary efficacy of SNK01 measured by Alzheimer's Disease Composite Score (ADCOMS).
Time frame: Baseline, Week 11, End of Study (Week 22)
To assess preliminary efficacy of SNK01 measured by cerebrospinal fluid (CSF) biomarkers: amyloid beta 42, T-tau and P-tau.
Time frame: Baseline, Week 11, End of Study (Week 22)
Results and safety
The study was stopped early (reason given: The study was terminated after completing the dose escalation portion of the study. The expansion cohort was not initiated to conduct a global trial based on the approved US IND using a new manufacturing process.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Derived from this study: PubMed 39939891Zuniga CH, Acosta BI, Menchaca R, Amescua CA, Hong S, Hui L, Gil M, Rhee YH, Yoon S, Kim M, Chang PY, Kim YM, Song PY, Betito K. Treatment of Alzheimer's Disease subjects with expanded non-genetically modified autologous natural killer cells (SNK01): a phase I study. Alzheimers Res Ther. 2025 Feb 12;17(1):40. doi: 10.1186/s13195-025-01681-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clemente Humberto Zúñiga Gil, MD principal investigator
Hospital Angeles Tijuana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SNK01 in people with Alzheimer Disease and Neuro-Degenerative Disease, run by NKGen Biotech, Inc. at 1 site in Mexico.
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 8 inclusion and 15 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: stopped early, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated after completing the dose escalation portion of the study. The expansion cohort was not initiated to conduct a global trial based on the approved US IND using a new manufacturing process.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the safety profile of SNK01 monotherapy in patients with mild cognitive impairment (MCI) or Alzheimer's Disease by monitoring for adverse events. (time frame: Up to 6 months). The study lists 3 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 NCT04678453, which also lists 1 linked publication.
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 1 Mar 2024.