Mycosis FungoidesPhase 1NCT04118868
Pembrolizumab Administered Via the Sofusa® DoseConnect™ in Patients With Relapsed/Refractory Cutaneous T-cell Lymphoma.
A Phase 1 study testing Pembrolizumab administered using the Sofusa® DoseConnect™ in people with Mycosis Fungoides, run by Sorrento Therapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycosis Fungoides
- What is being tested?
- Pembrolizumab administered using the Sofusa® DoseConnect™
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2022to 27 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
City of Hope
Duarte, California, 91010
Melissa Banez, 626-218-8276, mbanez@coh.org
Christiane Querfeld, MD
About this study
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)
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.
Read the 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.
- Conditions
- Mycosis Fungoides
- Being tested
- Pembrolizumab administered using the Sofusa® DoseConnect™
- Keywords
- CTCL, Cutaneous T-cell Lymphoma, MF/SS, Mycosis Fungoides, pembrolizumab, PD-L1
- Medical subject headings
- Mycosis Fungoides, Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pembrolizumab administered using the Sofusa® DoseConnect™Combination product
Also called Keytruda® administered using Sofusa® DoseConnect™ device
pembrolizumab will be administered intralymphatically using the Sofusa® DoseConnect™ device
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | Pembrolizumab administered intralymphatically using the Sofusa® DoseConnect™device Receives: Combination Product: Pembrolizumab administered using the Sofusa® DoseConnect™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Approximately 14 months
Secondary outcomes (5)
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™
Measured: Approximately 24 months
Area Under the Curve (AUC) of the blood levels of pembrolizumab
Measure the actual body exposure to pembrolizumab
Measured: Approximately 17 months
Maximum Plasma Concentration (Cmax) of pembrolizumab
Measure the maximum (or peak) blood concentration of pembrolizumab
Measured: Approximately 17 months
Time of Maximum concentration observed (Tmax) of pembrolizumab
Measure the is the time at which the maximum blood concentration of pembrolizumab is observed
Measured: Approximately 17 months
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%
Measured: Approximately 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start31 Aug 2022
- Primary completion29 Jan 2024 (estimated)
- Study completion27 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mycosis FungoidesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sorrento Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andreas G Niethammer, MD PhD, Study director, Sorrento Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118868
- Sponsor's protocol ID
- STI-SOFUSA-1001
- Status last verified
- Oct 2022
- First submitted
- 4 Oct 2019
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 33072126
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04118868
- Acronym / sponsor ID
- STI-SOFUSA-1001
- Conditions
- Mycosis Fungoides
- Keywords
- CTCL, Cutaneous T-cell Lymphoma, MF/SS, Mycosis Fungoides, pembrolizumab, PD-L1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sorrento Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 29 Jan 2024 (estimated)
- Study completion
- 27 Mar 2024 (estimated)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Combination Product: Pembrolizumab administered using the Sofusa® DoseConnect™Pembrolizumab administered intralymphatically using the Sofusa® DoseConnect™device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pembrolizumab administered using the Sofusa® DoseConnect™Also: Keytruda® administered using Sofusa® DoseConnect™ devicepembrolizumab will be administered intralymphatically using the Sofusa® DoseConnect™ device | Combination product | All participants |
Primary outcome
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
5 secondary outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of pembrolizumab administered by the Sofusa® DoseConnect™ device
Time frame: Approximately 24 months
Area Under the Curve (AUC) of the blood levels of pembrolizumab
Time frame: Approximately 17 months
Maximum Plasma Concentration (Cmax) of pembrolizumab
Time frame: Approximately 17 months
Time of Maximum concentration observed (Tmax) of pembrolizumab
Time frame: Approximately 17 months
Half-life (t1/2) of pembrolizumab
Time frame: Approximately 17 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Derived from this study: PubMed 33072126Narducci 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas G Niethammer, MD PhD study director
Sorrento Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pembrolizumab administered using the Sofusa® DoseConnect™ in people with Mycosis Fungoides, run by Sorrento Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas G Niethammer, MD PhD (+18583494820, ANiethammer@Sorrentotherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacodynamic effect of pembrolizumab administered by the Sofusa® DoseConnect™ device (time frame: Approximately 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04118868, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.