Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SNK01 · 3 trials · 9 indications
Evaluate the safety and tolerability of SNK01 assessed by labs, PE and AEs
DLTs will be assessed by the review of labs, PE and AEs
Determine the maximum tolerated dose based on the evaluation of the number of participants who experience a DLT which will then determine the RP2D.
Measure changes in cognitive assessment of CDR-SB from baseline
Measure changes in cognitive assessment of MMSE from baseline
Measure changes in cognitive assessment of NPI from baseline
Measure changes in cognitive assessment of ADCS-ADL-Severe from baseline
Measure changes in cognitive assessment of ADAS-Cog from baseline
Assessed by the incidence and severity of dose limiting toxicity (DLT) and other adverse events graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 5.0, or the cytokine release syndrome revised grading system.
| Arm | Type | Description |
|---|---|---|
| Open-Label | EXPERIMENTAL | SNK01 |
| SNK01 | EXPERIMENTAL | SNK01 will be administered as an IV infusion Q3W for up to 1 year. |
| Placebo | PLACEBO_COMPARATOR | Placebo will be administered as an IV infusion Q3W for up to 1 year. |
| Cohort 1 - Low dose SNK01 | EXPERIMENTAL | SNK01 (low dose) administered once a week for five weeks. |
| Cohort 2 - Medium dose SNK01 | EXPERIMENTAL | SNK01 (medium dose) administered once a week for five weeks. |
| Cohort 3 - High dose SNK01 | EXPERIMENTAL | SNK01 (high dose) administered once a week for five weeks. |
| Cohort 4 - SNK01 with avelumab | EXPERIMENTAL | SNK01 (high dose) administered in combination with avelumab once every two weeks (14-day cycle) for five cycles. |
| Cohort 4 - SNK01 with pembrolizumab | EXPERIMENTAL | SNK01 (high dose) administered in combination with pembrolizumab once every three weeks (21-day cycle) for five cycles. |
| Name | Type | Description |
|---|---|---|
| SNK01 | BIOLOGICAL | SNK01 is a novel cell-based, patient specific ex vivo expanded autologous natural killer (NK) cell, immunotherapeutic drug |
| Placebo | OTHER | Sodium Lactate Hartmann's Solution |
| Avelumab | DRUG | Avelumab is a humanized monoclonal antibody immune checkpoint blockade immunotherapy that targets the programmed cell death-ligand 1 (PD-L1). |
| Pembrolizumab | DRUG | Pembrolizumab is a humanized monoclonal antibody immune checkpoint blockade immunotherapy that targets the programmed cell death receptor-1 (PD-1). |
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 ...
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