Open-Label Extension Protocol to SNK01-AD01 Study

NCT07228078 | Recruiting Phase 2 FDA Drug

• 1 other identifier: SNK01-AD02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Open-Label Extension Protocol to SNK01-AD01 Study

Conditions

Alzheimer Disease

Keywords

Moderate Alzheimer's Disease; AD

Outcome Measures

Primary Outcomes (1)

• 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

  1 Year

Secondary Outcomes (5)

• Preliminary efficacy in cognitive assessment scores of CDR-SB

  1 Year

• Preliminary efficacy in cognitive assessment scores of MMSE

  1 Year

• Preliminary efficacy in cognitive assessment scores of NPI

  1 Year

• Preliminary efficacy in cognitive assessment scores of ADCS-ADL-Severe

  1 Year

• Preliminary efficacy in cognitive assessment scores of ADAS-Cog

  1 Year

Study Arms (1)

Open-Label

EXPERIMENTAL

SNK01

Biological: SNK01

Interventions

SNK01 BIOLOGICAL

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

Open-Label

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NKGen Biotech, Inc.: lead

Study Sites (1)

Behavioral Research Specialists, LLC

Glendale, California, 91206, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Study Director

CONTACT

949-396-6830; trials@nkgenbiotech.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2025
• First Posted: November 13, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)