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Open-Label Extension Protocol to SNK01-AD01 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-Label | Experimental | SNK01 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SNK01 | Biological | SNK01 is a novel cell-based, patient specific ex vivo expanded autologous natural killer (NK) cell, immunotherapeutic drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Preliminary efficacy in cognitive assessment scores of CDR-SB | Measure changes in cognitive assessment of CDR-SB from baseline | 1 Year |
| Preliminary efficacy in cognitive assessment scores of MMSE |
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Inclusion Criteria:
Participants will be considered eligible for participation in the study if all the following criteria are satisfied:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Contact | 949-396-6830 | trials@nkgenbiotech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Behavioral Research Specialists, LLC | Recruiting | Glendale | California | 91206 | United States |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Measure changes in cognitive assessment of MMSE from baseline
| 1 Year |
| Preliminary efficacy in cognitive assessment scores of NPI | Measure changes in cognitive assessment of NPI from baseline | 1 Year |
| Preliminary efficacy in cognitive assessment scores of ADCS-ADL-Severe | Measure changes in cognitive assessment of ADCS-ADL-Severe from baseline | 1 Year |
| Preliminary efficacy in cognitive assessment scores of ADAS-Cog | Measure changes in cognitive assessment of ADAS-Cog from baseline | 1 Year |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |