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

Primary Purpose

Mycosis Fungoides

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Pembrolizumab administered using the Sofusa® DoseConnect™

About this trial

This is an interventional treatment trial for Mycosis Fungoides focused on measuring CTCL, Cutaneous T-cell Lymphoma, MF/SS, Mycosis Fungoides, pembrolizumab, PD-L1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

City of HopeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All participants

Arm Description

Pembrolizumab administered intralymphatically using the Sofusa® DoseConnect™device

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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™

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

Measure the actual body exposure to pembrolizumab

Maximum Plasma Concentration (Cmax) of pembrolizumab

Measure the maximum (or peak) blood concentration of pembrolizumab

Time of Maximum concentration observed (Tmax) of pembrolizumab

Measure the is the time at which the maximum blood concentration of pembrolizumab is observed

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%

Full Information

NCT ID

NCT04118868

First Posted

October 4, 2019

Last Updated

October 7, 2022

Sponsor

Sorrento Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04118868

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 31, 2022 (Actual)

Primary Completion Date

January 29, 2024 (Anticipated)

Study Completion Date

March 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sorrento Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mycosis Fungoides

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

All participants

Arm Type

Experimental

Arm Description

Pembrolizumab administered intralymphatically using the Sofusa® DoseConnect™device

Intervention Type

Combination Product

Intervention Name(s)

Pembrolizumab administered using the Sofusa® DoseConnect™

Other Intervention Name(s)

Keytruda® administered using Sofusa® DoseConnect™ device

Intervention Description

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

Primary Outcome Measure Information:

Title

Pharmacodynamic effect of pembrolizumab administered by the Sofusa® DoseConnect™ device

Description

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

Time Frame

Approximately 14 months

Secondary Outcome Measure Information:

Title

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

Description

Terms, frequency, severity and seriousness of adverse events (AEs) and relationship of AEs to pembrolizumab and/or Sofusa® DoseConnect™

Time Frame

Approximately 24 months

Title

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

Description

Measure the actual body exposure to pembrolizumab

Time Frame

Approximately 17 months

Title

Maximum Plasma Concentration (Cmax) of pembrolizumab

Description

Measure the maximum (or peak) blood concentration of pembrolizumab

Time Frame

Approximately 17 months

Title

Time of Maximum concentration observed (Tmax) of pembrolizumab

Description

Measure the is the time at which the maximum blood concentration of pembrolizumab is observed

Time Frame

Approximately 17 months

Title

Half-life (t1/2) of pembrolizumab

Description

Measure the time it takes for the concentration of the pembrolizumab in the blood to be reduced by 50%

Time Frame

Approximately 17 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andreas G Niethammer, MD PhD

Phone

+18583494820

ANiethammer@Sorrentotherapeutics.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andreas G Niethammer, MD PhD

Organizational Affiliation

Sorrento Therapeutics, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

City of Hope

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Melissa Banez

Phone

626-218-8276

mbanez@coh.org

First Name & Middle Initial & Last Name & Degree

Christiane Querfeld, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33072126

Citation

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.

Results Reference

derived

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

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