Open-label extension of SNK01-AD01
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)
People with moderate Alzheimer's will receive SNK01 by IV every three weeks to see if it stays safe and well tolerated over the long term.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | NKGen Biotech, Inc. Industry-sponsored |
| Locations | 1 site (Glendale, California) |
| Trial ID | NCT07228078 on ClinicalTrials.gov |
What this trial studies
This is an open-label Phase 2 extension that continues SNK01 treatment for participants with Alzheimer's disease on a schedule of intravenous infusions every three weeks. The main focus is to monitor long-term safety and tolerability while participants continue to receive the investigational agent. Participants must provide informed consent (or have a legally authorized representative do so) and have a reliable caregiver or study partner to assist with visits and functional assessments. Routine clinical and safety assessments will be performed at scheduled visits at the study site in Glendale, California.
Who should consider this trial
Good fit: Ideal candidates are adults with moderate Alzheimer's disease who are willing and able to receive IV infusions every three weeks, have a reliable caregiver or study partner, and can provide informed consent or have a legally authorized representative do so.
Not a fit: Patients with severe disease, unstable medical conditions, inability to attend frequent infusion visits, or no available caregiver are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the extension could show SNK01 is tolerable when given long-term, supporting continued development and potential future treatment options for patients.
How similar studies have performed: Open-label extension designs are commonly used to gather long-term safety data for biologic therapies in Alzheimer's, but prior programs have shown mixed clinical benefit, so long-term safety data are useful but not yet predictive of effectiveness for SNK01.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Glendale, California
- Behavioral Research Specialists, LLC — Glendale, California, United States (Recruiting)
Study contacts
- Study coordinator: Study Director
- Email: trials@nkgenbiotech.com
- Phone: 949-396-6830
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.