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

October 7, 2022 updated by: Sorrento Therapeutics, Inc.

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Contact:
        • Principal Investigator:
          • Christiane Querfeld, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All participants
Pembrolizumab administered intralymphatically using the Sofusa® DoseConnect™device
Combination product: Pembrolizumab administered using the Sofusa® DoseConnect™
pembrolizumab will be administered intralymphatically using the Sofusa® DoseConnect™ device
Other Names:
  • Keytruda® administered using Sofusa® DoseConnect™ device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacodynamic effect of pembrolizumab administered by the Sofusa® DoseConnect™ device
Time Frame: 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
Approximately 14 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of pembrolizumab administered by the Sofusa® DoseConnect™ device
Time Frame: Approximately 24 months
Terms, frequency, severity and seriousness of adverse events (AEs) and relationship of AEs to pembrolizumab and/or Sofusa® DoseConnect™
Approximately 24 months
Area Under the Curve (AUC) of the blood levels of pembrolizumab
Time Frame: Approximately 17 months
Measure the actual body exposure to pembrolizumab
Approximately 17 months
Maximum Plasma Concentration (Cmax) of pembrolizumab
Time Frame: Approximately 17 months
Measure the maximum (or peak) blood concentration of pembrolizumab
Approximately 17 months
Time of Maximum concentration observed (Tmax) of pembrolizumab
Time Frame: Approximately 17 months
Measure the is the time at which the maximum blood concentration of pembrolizumab is observed
Approximately 17 months
Half-life (t1/2) of pembrolizumab
Time Frame: Approximately 17 months
Measure the time it takes for the concentration of the pembrolizumab in the blood to be reduced by 50%
Approximately 17 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sorrento Therapeutics, Inc.

Investigators

  • Study Director: Andreas G Niethammer, MD PhD, Sorrento Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2022

Primary Completion (Anticipated)

January 29, 2024

Study Completion (Anticipated)

March 27, 2024

Study Registration Dates

First Submitted

October 4, 2019

First Submitted That Met QC Criteria

October 7, 2019

First Posted (Actual)

October 8, 2019

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 7, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STI-SOFUSA-1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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