Alzheimer DiseasePhase 2NCT07228078
Open-Label Extension Protocol to SNK01-AD01 Study
A Phase 2 study testing SNK01 in people with Alzheimer Disease, run by NKGen Biotech, Inc. at 1 site in United States.
Trial summary
Open-Label Extension Protocol to SNK01-AD01 Study Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- SNK01
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2025to Apr 2028
- Phase
- Phase 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
- Participants will be considered eligible for participation in the study if all the following criteria are satisfied:
- 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 subject).
- 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.
- Participants previously completed participation in study SNK01-AD01.
Who cannot join
- Participants who fulfill any of the following criteria will not be recruited into the study:
- Any participant whose safety the investigator considers to be at risk from this trial's intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Behavioral Research Specialists, LLC
Glendale, California, 91206
Harry Chung, (888) 255-5798, harry@brstrials.com
About this study
Official title: An Open-Label Extension (OLE) Study to Evaluate the Long-Term Safety, Tolerability and Exploratory Efficacy of SNK01 in Participants With Alzheimer's Disease (Study SNK01-AD02)
Open-Label Extension Protocol to SNK01-AD01 Study
Read the detailed description
Open-label extension study to assess long-term safety and tolerability of SNK01 administered as an intravenous (IV) infusion every 3 weeks in participants with Alzheimer's Disease
- Conditions
- Alzheimer Disease
- Being tested
- SNK01
- Keywords
- Moderate Alzheimer's Disease, AD
- Medical subject headings
- Alzheimer Disease
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
| Study group | Role | What they receive |
|---|---|---|
| Open-Label | Experimental | SNK01 Receives: Biological: SNK01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (5)
Preliminary efficacy in cognitive assessment scores of CDR-SB
Measure changes in cognitive assessment of CDR-SB from baseline
Measured: 1 Year
Preliminary efficacy in cognitive assessment scores of MMSE
Measure changes in cognitive assessment of MMSE from baseline
Measured: 1 Year
Preliminary efficacy in cognitive assessment scores of NPI
Measure changes in cognitive assessment of NPI from baseline
Measured: 1 Year
Preliminary efficacy in cognitive assessment scores of ADCS-ADL-Severe
Measure changes in cognitive assessment of ADCS-ADL-Severe from baseline
Measured: 1 Year
Preliminary efficacy in cognitive assessment scores of ADAS-Cog
Measure changes in cognitive assessment of ADAS-Cog 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.
- First posted13 Nov 2025
- Study start30 Jun 2025
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NKGen Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228078
- Sponsor's protocol ID
- SNK01-AD02
- Status last verified
- Nov 2025
- First submitted
- 12 Nov 2025
- Last updated
- 13 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Extension (OLE) Study to Evaluate the Long-Term Safety, Tolerability and Exploratory Efficacy of SNK01 in Participants With Alzheimer's Disease (Study SNK01-AD02)
- ClinicalTrials.gov ID
- NCT07228078
- Acronym / sponsor ID
- SNK01-AD02
- Conditions
- Alzheimer Disease
- Keywords
- Moderate Alzheimer's Disease, AD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- NKGen Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 13 Nov 2025 (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.
Open-Label Extension Protocol to SNK01-AD01 Study
Detailed description
Open-label extension study to assess long-term safety and tolerability of SNK01 administered as an intravenous (IV) infusion every 3 weeks in participants with Alzheimer's Disease
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-Label | Experimental | Biological: SNK01SNK01 |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants will be considered eligible for participation in the study if all the following criteria are satisfied:
- 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 subject).
- 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.
- Participants previously completed participation in study SNK01-AD01.
Key exclusion criteria (2 listed)
- Participants who fulfill any of the following criteria will not be recruited into the study:
- Any participant whose safety the investigator considers to be at risk from this trial's intervention.
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 |
|---|---|---|
| SNK01SNK01 is a novel cell-based, patient specific ex vivo expanded autologous natural killer (NK) cell, immunotherapeutic drug | Biological | Open-Label |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 1 Year
Evaluate the safety and tolerability of SNK01 assessed by labs, PE and AEs
5 secondary outcomes
Preliminary efficacy in cognitive assessment scores of CDR-SB
Time frame: 1 Year
Preliminary efficacy in cognitive assessment scores of MMSE
Time frame: 1 Year
Preliminary efficacy in cognitive assessment scores of NPI
Time frame: 1 Year
Preliminary efficacy in cognitive assessment scores of ADCS-ADL-Severe
Time frame: 1 Year
Preliminary efficacy in cognitive assessment scores of ADAS-Cog
Time frame: 1 Year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SNK01 in people with Alzheimer Disease, run by NKGen Biotech, Inc. at 1 site in United States.
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 4 inclusion and 2 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 13 Nov 2025. 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 United States. 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 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 treatment-related adverse events as assessed by CTCAE v5.0 (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2025.