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

Last updated: October 7, 2022
Sponsor: Sorrento Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoma

Lymphoproliferative Disorders

Cutaneous T-cell Lymphoma

Treatment

N/A

Clinical Study ID

NCT04118868
STI-SOFUSA-1001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofcontraceptive 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 theduration of the study and for at least 120 days (4 months) following the last dose ofstudy intervention

Exclusion

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, orhistory of syndrome that required systemic steroids or immunosuppressive medications,except for participants with vitiligo, hormone replacement therapy for stable thyroiddiseases and Type 1 diabetes mellitus.
  • Prior allogeneic hematopoietic stem cell transplantation (HSCT) or solid organtransplantation.
  • Known seropositive for or have active infection with hepatitis C virus (HCV) orhepatitis B virus (HBV), or human immunodeficiency virus (HIV)
  • History of interstitial lung disease
  • History of severe hypersensitivity reactions to other monoclonal antibodies or knownhypersensitivity to the study intervention or its excipients, indocyanine green dye oriodine.
  • Known current drug or alcohol abuse.
  • Pregnant or lactating.
  • Underlying medical condition resulting in abnormally slow lymphatic flow as determinedby the Investigator.
  • Require immediate treatment for MF

Study Design

Total Participants: 10
Study Start date:
August 31, 2022
Estimated Completion Date:
March 27, 2024

Study 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.

Connect with a study center

  • City of Hope

    Duarte, California 91010
    United States

    Active - Recruiting

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