Open-Label Extension Protocol to SNK01-AD01 Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2028-04-30

Brief Summary

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Open-Label Extension Protocol to SNK01-AD01 Study

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Detailed Description

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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

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open-Label

SNK01

Group Type EXPERIMENTAL

SNK01

Intervention Type BIOLOGICAL

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

Interventions

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SNK01

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No