Open-Label Extension Protocol to SNK01-AD01 Study

November 12, 2025 updated by: NKGen Biotech, Inc.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Glendale, California, United States, 91206
        • Recruiting
        • Behavioral Research Specialists, LLC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open-Label
SNK01
Biological: SNK01
SNK01 is a novel cell-based, patient specific ex vivo expanded autologous natural killer (NK) cell, immunotherapeutic drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preliminary efficacy in cognitive assessment scores of CDR-SB
Time Frame: 1 Year
Measure changes in cognitive assessment of CDR-SB from baseline
1 Year
Preliminary efficacy in cognitive assessment scores of MMSE
Time Frame: 1 Year
Measure changes in cognitive assessment of MMSE from baseline
1 Year
Preliminary efficacy in cognitive assessment scores of NPI
Time Frame: 1 Year
Measure changes in cognitive assessment of NPI from baseline
1 Year
Preliminary efficacy in cognitive assessment scores of ADCS-ADL-Severe
Time Frame: 1 Year
Measure changes in cognitive assessment of ADCS-ADL-Severe from baseline
1 Year
Preliminary efficacy in cognitive assessment scores of ADAS-Cog
Time Frame: 1 Year
Measure changes in cognitive assessment of ADAS-Cog from baseline
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NKGen Biotech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2025

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

November 12, 2025

First Submitted That Met QC Criteria

November 12, 2025

First Posted (Estimated)

November 13, 2025

Study Record Updates

Last Update Posted (Estimated)

November 13, 2025

Last Update Submitted That Met QC Criteria

November 12, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNK01-AD02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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