Natural Killer Cell Therapy (UD TGFbetai NK Cells) and Temozolomide for the Treatment of Stage IV Melanoma Metastatic to the Brain

Assessed using CTCAE V5.0. All toxicities will be summarized as the percentage of patients experiencing each type and grade of event according to dose level. Patients who receive at least one dose of treatment will be included in the analysis. Frequency and severity of AEs and tolerability of the regimen will be collected and summarized by descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.

Assessed using RECIST criteria. Will be calculated as the proportion of patients who achieve a response to therapy divided by the total number of evaluable patients. An evaluable patient is defined as an eligible patient who has received at least one dose of therapy. All evaluable patients will be included in calculating the response rate for the study along with corresponding 95% binomial CIs (assuming that the number of patients who respond is binomially distributed).

Survival will initially be modeled using Kaplan-Meier methods, resulting in median survival times with 95% confidence interval (CI), assuming sufficient events have occurred.

Survival will initially be modeled using Kaplan-Meier methods, resulting in median survival times with 95% CI, assuming sufficient events have occurred.

The percentage of patients with adverse events as assessed by CTCAE V 5.0 criteria. Frequency and severity of AEs will be collected and summarized by descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns

The samples will be analyzed using the Devyser Chimerism assay to identify the UD TGFbeta iNK cells. We will use graphical analyses as well as repeated measure models (linear or nonlinear mixed models, generalized estimating equations [GEE]) to assess the PK described above in relation to clinical treatment outcomes, recognizing some inherent limitations due to sample size.

Will be correlated with clinical outcomes. Graphical analyses will be largely used to assess potential patterns and relationships. All continuous measurements will be summarized using mean +/- standard error of the mean (SEM), range, and median at each time point. Associations with clinical outcomes will be evaluated using two-sample t test or Fisher exact test.

Graphical analyses will be largely used to assess potential patterns and relationships. All continuous measurements will be summarized using mean +/- SEM, range, and median at each time point. Associations with clinical outcomes will be evaluated using two-sample t test or Fisher exact test.

Graphical analyses will be largely used to assess potential patterns and relationships. All continuous measurements will be summarized using mean +/- SEM, range, and median at each time point. Associations with clinical outcomes will be evaluated using two-sample t test or Fisher exact test.

Graphical analyses will be largely used to assess potential patterns and relationships. All continuous measurements will be summarized using mean +/- SEM, range, and median at each time point. Associations with clinical outcomes will be evaluated using two-sample t test or Fisher exact test.