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

NCT04118868 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-10-12

No results posted yet for this 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.

Conditions

  • Mycosis Fungoides

Interventions

COMBINATION_PRODUCT

Pembrolizumab administered using the Sofusa® DoseConnect™

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

Sponsors & Collaborators

  • Sorrento Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Andreas G Niethammer, MD PhD · Sorrento Therapeutics, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2024-01-29
Completion
2024-03-27
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04118868 on ClinicalTrials.gov