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NCT Number: NCT07228078

Open-Label Extension Protocol to SNK01-AD01 Study

Open-Label Extension Protocol to SNK01-AD01 Study

Recruiting

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Behavioral Research Specialists, LLC

Glendale, California, 91206, United States

Location status: Recruiting

Location contact

Harry Chung

CONTACT

[email protected]

(888) 255-5798

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SNK01

Biological

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Preliminary efficacy in cognitive assessment scores of CDR-SB

    Time frame: 1 Year

    Measure changes in cognitive assessment of CDR-SB from baseline

  2. Preliminary efficacy in cognitive assessment scores of MMSE

    Time frame: 1 Year

    Measure changes in cognitive assessment of MMSE from baseline

  3. Preliminary efficacy in cognitive assessment scores of NPI

    Time frame: 1 Year

    Measure changes in cognitive assessment of NPI from baseline

  4. 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

  5. Preliminary efficacy in cognitive assessment scores of ADAS-Cog

    Time frame: 1 Year

    Measure changes in cognitive assessment of ADAS-Cog from baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Study Director

CONTACT

[email protected]

949-396-6830

Sponsors and collaborators

Lead sponsor

NKGen Biotech, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 13, 2025
Registry last updated
Nov 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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