Recruiting
Phase 1

Pembrolizumab

Sponsor:

Sorrento Therapeutics, Inc.

Code:

NCT04118868

Conditions

Mycosis Fungoides

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pembrolizumab administered using the Sofusa® DoseConnect™

Study Details

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.

Conditions

Mycosis Fungoides

Study ID

NCT04118868

Start date

Aug 31, 2022

Status verified date

Oct, 2022

Completion date

Mar 27, 2024

Anticipated

Primary completion date

Jan 29, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: All participants

Pembrolizumab administered intralymphatically using the Sofusa® DoseConnect™device

Interventions

Pembrolizumab administered using the Sofusa® DoseConnect™

pembrolizumab will be administered intralymphatically using the Sofusa® DoseConnect™ device

Primary outcome measure

  • Pharmacodynamic effect of pembrolizumab administered by the Sofusa® DoseConnect™ device [ Time Frame: Approximately 14 months ]

Central Contacts and Locations

Central contacts

Andreas G Niethammer, MD PhD

+18583494820ANiethammer@Sorrentotherapeutics.com

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

Melissa Banez

626-218-8276mbanez@coh.org

Principal Investigator:

Christiane Querfeld, MD

More Information

Sponsor

Sorrento Therapeutics, Inc.

Last update posted

Oct 12, 2022

Last verified

Oct, 2022

Keywords

  • CTCL
  • Cutaneous T-cell Lymphoma
  • MF/SS
  • Mycosis Fungoides
  • pembrolizumab
  • PD-L1

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Sorrento Therapeutics, Inc. on 2022-10-12.