Open Label, Single-cohort, and Single-center Phase II Study Evaluating Tumor-specific Immunity After Extracorporeal Photopheresis in Patients with Sézary Syndrome At Single-cell Resolution
The primary endpoint is to determine if ECP induces a decrease in % of tumor cells after treatment. 15 patients with Sezary Syndrome will receive ECP weekly x4, then bi-weekly for 5 months. Each patient will donate 5 samples to determine immune responses in peripheral blood. Additional clinical assessments will be a modified skin weighted assessment and flow cytometry at baseline and months 3 and 6. A CT scan will be obtained at baseline and only repeated if pathology is present at baseline. The tumor microenvironment will be studied by comparing transcriptomics of the blood samples before, 1 day after first ECP treatment, cycle 1, 1, 3 and 6 months after ECP treatment by scRNAseq (5 samples total per patient ).
• Patient with an established diagnosis of Sezary syndrome (stage IVA1)
• The patient must have a minimum wash-out period of 3 weeks between the last dose of prior systemic therapy
• Patients should have recovered from all adverse events related to prior therapy to ≤ grade 1
• Signed informed consent form prior to any protocol-specific procedures.