Pembrolizumab Administered Via the Sofusa® DoseConnect™ in Patients With Relapsed/Refractory Cutaneous T-cell Lymphoma.

Mycosis Fungoides Clinical Trial

Official title:

Phase 1B, Pilot Study to Assess the Pharmacodynamics, Pharmacokinetics, Safety, Activity of Pembrolizumab Administered Intra-lymphatically Using the Sofusa® DoseConnect™ in Patients With Relapsed/Refractory Cutaneous T- Cell Lymphoma (CTCL)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04118868
• Other study ID #: STI-SOFUSA-1001
• Status: Recruiting
• Phase: Phase 1
• Start date: August 31, 2022
• Est. completion date: March 27, 2024

Study information

• Verified date: October 2022
• Source: Sorrento Therapeutics, Inc.
• Contact: Andreas G Niethammer, MD PhD
• Phone: +18583494820
• Email: ANiethammer[@]Sorrentotherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 27, 2024
• Est. primary completion date: January 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Lymphoma, T-Cell, Peripheral
• Mycoses
• Mycosis Fungoides

Intervention

Combination Product:
• Pembrolizumab administered using the Sofusa® DoseConnect™
pembrolizumab will be administered intralymphatically using the Sofusa® DoseConnect™ device

Locations

Country	Name	City	State
United States	City of Hope	Duarte	California

Sponsors (1)

Lead Sponsor	Collaborator
Sorrento Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacodynamic 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	Approximately 14 months
Secondary	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™	Approximately 24 months
Secondary	Area Under the Curve (AUC) of the blood levels of pembrolizumab	Measure the actual body exposure to pembrolizumab	Approximately 17 months
Secondary	Maximum Plasma Concentration (Cmax) of pembrolizumab	Measure the maximum (or peak) blood concentration of pembrolizumab	Approximately 17 months
Secondary	Time of Maximum concentration observed (Tmax) of pembrolizumab	Measure the is the time at which the maximum blood concentration of pembrolizumab is observed	Approximately 17 months
Secondary	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%	Approximately 17 months