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

NCT04118868 | Unknown Phase 1 FDA Drug FDA Device

• 1 other identifier: STI-SOFUSA-1001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of pembrolizumab administered by the Sofusa® DoseConnect™ device

  Approximately 24 months

• Area Under the Curve (AUC) of the blood levels of pembrolizumab

  Approximately 17 months

• Maximum Plasma Concentration (Cmax) of pembrolizumab

  Approximately 17 months

• Time of Maximum concentration observed (Tmax) of pembrolizumab

  Approximately 17 months

• Half-life (t1/2) of pembrolizumab

  Approximately 17 months

Study Arms (1)

All participants

EXPERIMENTAL

Pembrolizumab administered intralymphatically using the Sofusa® DoseConnect™device

Combination Product: Pembrolizumab administered using the Sofusa® DoseConnect™

Interventions

Pembrolizumab administered using the Sofusa® DoseConnect™ COMBINATION_PRODUCT

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

Also known as: Keytruda® administered using Sofusa® DoseConnect™ device

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead

Study Sites (1)

City of Hope

Duarte, California, 91010, United States

RECRUITING

Related Publications (1)

• Narducci MG, Tosi A, Frezzolini A, Scala E, Passarelli F, Bonmassar L, Monopoli A, Accetturi MP, Cantonetti M, Antonini Cappellini GC, De Galitiis F, Rosato A, Picozza M, Russo G, D'Atri S. Reduction of T Lymphoma Cells and Immunological Invigoration in a Patient Concurrently Affected by Melanoma and Sezary Syndrome Treated With Nivolumab. Front Immunol. 2020 Sep 25;11:579894. doi: 10.3389/fimmu.2020.579894. eCollection 2020.

  PMID: 33072126 DERIVED

MeSH Terms

Conditions

Mycosis Fungoides; Lymphoma, T-Cell, Cutaneous

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Andreas G Niethammer, MD PhD

  Sorrento Therapeutics, Inc.

  STUDY DIRECTOR

Central Study Contacts

Andreas G Niethammer, MD PhD

CONTACT

+18583494820; ANiethammer@Sorrentotherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 8, 2019
• Study Start: August 31, 2022
• Primary Completion: January 29, 2024
• Study Completion: March 27, 2024
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)