In this pilot study, pembrolizumab will be administered via DoseConnect in patient with relapsed or refractory cutaneous T-cell lymphoma to assess through pharmacodynamic assessment in the tumor tissue to assess if lymphatic delivery of pembrolizumab using Sofusa DoseConnect is feasible.
This is an open-label, single-center pilot study to investigate the pharmacodynamics, pharmacokinetics (PK), safety, and activity of pembrolizumab administered intra-lymphatically using the DoseConnect in participants with relapsed or refractory cutaneous T-cell lymphoma (CTCL). All participants will receive the study intervention, pembrolizumab administered intralymphatically using the Sofusa DoseConnect device.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
pembrolizumab will be administered intralymphatically using the Sofusa® DoseConnect™ device
City of Hope
Duarte, California, United States
RECRUITINGPharmacodynamic effect of pembrolizumab administered by the Sofusa® DoseConnect™ device
T-cell exhaustion/activation markers: PD-1, Lag-3, Tim-3, ICOS, HLA-DR and Granzyme B in CD3+CD4+ malignant and CD3+CD8+ tumor-infiltrating T-cells in tumor tissue
Time frame: Approximately 14 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of pembrolizumab administered by the Sofusa® DoseConnect™ device
Terms, frequency, severity and seriousness of adverse events (AEs) and relationship of AEs to pembrolizumab and/or Sofusa® DoseConnect™
Time frame: Approximately 24 months
Area Under the Curve (AUC) of the blood levels of pembrolizumab
Measure the actual body exposure to pembrolizumab
Time frame: Approximately 17 months
Maximum Plasma Concentration (Cmax) of pembrolizumab
Measure the maximum (or peak) blood concentration of pembrolizumab
Time frame: Approximately 17 months
Time of Maximum concentration observed (Tmax) of pembrolizumab
Measure the is the time at which the maximum blood concentration of pembrolizumab is observed
Time frame: Approximately 17 months
Half-life (t1/2) of pembrolizumab
Measure the time it takes for the concentration of the pembrolizumab in the blood to be reduced by 50%
Time frame: Approximately 17 months
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