Recruiting
Phase 2

SNK01-AD01

Sponsor:

NKGen Biotech, Inc.

Code:

NCT07228078

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

SNK01

Study Details

Brief summary:

Open-Label Extension Protocol to SNK01-AD01 Study

Conditions

Alzheimer Disease

Study ID

NCT07228078

Start date

Jun 30, 2025

Status verified date

Nov, 2025

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Open-Label

SNK01

Interventions

SNK01

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

Primary outcome measure

  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: 1 Year ]

Central Contacts and Locations

Central contacts

Locations

Behavioral Research Specialists, LLC

Recruiting

Glendale, California, United States, 91206

Contacts

More Information

Sponsor

NKGen Biotech, Inc.

Last update posted

Nov 13, 2025

Last verified

Nov, 2025

Keywords

  • Moderate Alzheimer's Disease
  • AD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by NKGen Biotech, Inc. on 2025-11-13.