Mycosis Fungoides
Conditions
Keywords
CTCL, Cutaneous T-cell Lymphoma, MF/SS, Mycosis Fungoides, pembrolizumab, PD-L1
Brief summary
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.
Detailed description
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.
Interventions
COMBINATION_PRODUCTPembrolizumab administered using the Sofusa® DoseConnect™
pembrolizumab will be administered intralymphatically using the Sofusa® DoseConnect™ device
Sponsors
Sorrento Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of one of Mycosis fungoides (MF) * Stage IB to IIIB disease at screening * Received at least 1 previous line of systemic therapy for CTCL. (Participants with CD 30 positive MF must have received prior treatment with brentuximab vedotin.) * Documented disease progression during or after the last therapy. * Not previously treated with transplant and is ineligible for transplant * Willing to undergo two biopsies during the study * 18 years or older at the time of signing informed consent form (ICF) * Adequate organ function * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Females of childbearing potential (FCBP) must agree to use a reliable form of contraceptive for the duration of the study and for at least 120 days (4 months) following the last dose of study intervention. * Male participants must agree to use barrier contraception (i.e., condoms) for the duration of the study and for at least 120 days (4 months) following the last dose of study intervention
Exclusion criteria
* Disease with extensive visceral or blood involvement. * Previously treated with an anti-PD-L1 or anti-PD-1 antibody * Any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for participants with vitiligo, hormone replacement therapy for stable thyroid diseases and Type 1 diabetes mellitus. * Prior allogeneic hematopoietic stem cell transplantation (HSCT) or solid organ transplantation. * Known seropositive for or have active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV), or human immunodeficiency virus (HIV) * History of interstitial lung disease * History of severe hypersensitivity reactions to other monoclonal antibodies or known hypersensitivity to the study intervention or its excipients, indocyanine green dye or iodine. * Known current drug or alcohol abuse. * Pregnant or lactating. * Underlying medical condition resulting in abnormally slow lymphatic flow as determined by the Investigator. * Require immediate treatment for MF
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamic effect of pembrolizumab administered by the Sofusa® DoseConnect™ device | Approximately 14 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of pembrolizumab administered by the Sofusa® DoseConnect™ device | Approximately 24 months | Terms, frequency, severity and seriousness of adverse events (AEs) and relationship of AEs to pembrolizumab and/or Sofusa® DoseConnect™ |
| Area Under the Curve (AUC) of the blood levels of pembrolizumab | Approximately 17 months | Measure the actual body exposure to pembrolizumab |
| Maximum Plasma Concentration (Cmax) of pembrolizumab | Approximately 17 months | Measure the maximum (or peak) blood concentration of pembrolizumab |
| Time of Maximum concentration observed (Tmax) of pembrolizumab | Approximately 17 months | Measure the is the time at which the maximum blood concentration of pembrolizumab is observed |
| Half-life (t1/2) of pembrolizumab | Approximately 17 months | Measure the time it takes for the concentration of the pembrolizumab in the blood to be reduced by 50% |
Countries
United States
Contacts
Primary ContactAndreas G Niethammer, MD PhD
Outcome results
None listed