SNK01 for Alzheimer's Disease

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: NKGen Biotech, Inc.

Disqualifiers: Safety risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests SNK01, a treatment for Alzheimer's disease. The goal is to evaluate SNK01's effectiveness in individuals who participated in a previous study with this treatment. Participants must have completed the earlier SNK01 study and have a reliable caregiver to assist with assessments. The trial aims to gather more information about SNK01's effects on Alzheimer's symptoms and its overall safety. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that SNK01 is likely to be safe for humans?

Research has shown that SNK01 is well tolerated by people with Alzheimer's disease. One study found it very safe and noted benefits for brain proteins and inflammation. Another study reported SNK01 as safe when administered every three weeks for up to a year. While these studies primarily focused on safety, they also suggested possible improvements in memory and thinking skills. Overall, SNK01 appears safe, with no major side effects reported. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Alzheimer's disease, which often focus on managing symptoms with medications like cholinesterase inhibitors and memantine, SNK01 offers a fresh approach by targeting the disease at a cellular level. SNK01 is unique because it utilizes natural killer (NK) cells, which are a type of immune cell that may help in reducing the underlying neuroinflammation and clearing amyloid-beta plaques associated with Alzheimer's. Researchers are excited about SNK01 because it represents a potential new mechanism of action that could not only alleviate symptoms but also slow the progression of the disease by addressing its root causes.

What evidence suggests that SNK01 might be an effective treatment for Alzheimer's?

Research has shown that SNK01 might help people with Alzheimer's Disease. In some studies, 90% of patients who received SNK01 experienced either improved or stable memory and thinking skills after just four doses. Patients who completed 17 doses improved from moderate to mild Alzheimer's Disease in only three months. SNK01 is well tolerated, with patients not experiencing significant side effects. It appears to positively affect brain proteins and inflammation, which are important in Alzheimer's Disease. These findings suggest SNK01 could be a promising treatment for managing Alzheimer's symptoms. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with Alzheimer's Disease who have already completed the SNK01-AD01 study. They must be able to give informed consent and have a reliable caregiver to assist with assessments and communication during the trial.

Inclusion Criteria

I am willing and able to follow the study rules and have given my written consent.

I have someone who can help me with my study needs and communicate with the study team.

Participants previously completed participation in study SNK01-AD01.

Exclusion Criteria

Any participant whose safety the investigator considers to be at risk from this trial's intervention.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label extension

Participants receive SNK01 as an intravenous infusion every 3 weeks to assess long-term safety and tolerability

1 year

Visits every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SNK01

Trial Overview The trial is testing an intervention called SNK01, which was previously studied in the SNK01-AD01 study. This extension allows participants to continue or start receiving SNK01 under an open-label design, meaning both researchers and participants know what treatment is being given.

How Is the Trial Designed?

Group I: Open-Label Experimental Treatment 1 Intervention

SNK01

Who Is Running the Clinical Trial?

NKGen Biotech, Inc.

Lead Sponsor

Trials

7

Recruited

100+

Citations

1. biospace.com biospace.com/press-releases/nkgen-biotech-presents-data-from-phase-1-2a-clinical-trial-of-troculeucel-in-moderate-alzheimers-disease-at-the-international-conference-on-alzheimers-and-parkinsons-diseases-ad-pd-2025

NKGen Biotech Presents Data from Phase 1/2a Clinical ... After 12 months of treatment, both patients who completed 17 doses improved from moderate to mild AD within just 3 months. One patient ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06189963

NCT06189963 | Clinical Study of SNK01 in Participants ... 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:.

3. nkgenbiotech.com nkgenbiotech.com/nkgen-biotechs-snk01-nk-cell-therapy-cleared-to-start-phase-2-clinical-trial-in-alzheimers-disease/

NKGen Biotech's SNK01 NK Cell Therapy Cleared to Start ... Despite only receiving four doses, 90% of patients (median MMSE score of 14) demonstrated improvement or maintained stable cognitive function as ...

4. alzres.biomedcentral.com alzres.biomedcentral.com/articles/10.1186/s13195-025-01681-2

Treatment of Alzheimer's Disease subjects with expanded non ... SNK01 was well tolerated and appeared to have clinical activity in AD while also having beneficial effects on cerebrospinal fluid protein and neuroinflammatory ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39939891/

Treatment of Alzheimer's Disease subjects with expanded ... Conclusions: SNK01 was well tolerated and appeared to have clinical activity in AD while also having beneficial effects on cerebrospinal fluid ...

6. nkgenbiotech.com nkgenbiotech.com/nkgen-biotech-presents-additional-phase-1-clinical-trial-data-in-alzheimers-disease-at-the-tau2024-global-conference/

NKGen Biotech Presents Additional Phase 1 Clinical Trial ... The additional Phase 1 SNK01 trial data suggest clinical activity regarding cognitive function in patients with advanced Alzheimer's disease.

7. ddw-online.com ddw-online.com/the-killer-instinct-using-investigational-natural-killer-therapy-to-treat-alzheimers-28530-202402/

The killer instinct: Using natural killer therapy to treat ... Though the study was small and designed to primarily assess SNK01's safety, data indicate that the therapy may do more than slow the progression ...

8. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.072909

Use of Expanded Non‐genetically Modified Natural Killer ... SNK01 with high cytotoxicity and activating receptor expression can be consistently produced from patients with advanced AD. SNK01 was very safe ...