Clinical trial · Observational
Extracorporeal Photopheresis in Sezary Syndrome
Open Label, Single-cohort, and Multi-center Phase II Study Evaluating Tumor-specific Immunity After Extracorporeal Photopheresis in Patients With Sézary Syndrome at Single-cell Resolution
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary endpoint is to determine if ECP induces a decrease in % of tumor cells after treatment. 20 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 ).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sezary Syndrome | Sezary Syndrome | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Extracorporeal photopheresis (ECP) | Device | — | UNRESOLVED |
| Methoxsalen Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Sezary Syndrome
- description
- 20 subjects with Sezary Syndrome will comprise the single arm of this study
- interventionNames
- Device: Extracorporeal photopheresis (ECP)
- Drug: Methoxsalen Injection
Primary outcomes (2)
- measure
- Change from baseline in tumor-specific immunity
- timeFrame
- Up to 3 months post baseline
- description
- Evaluate immune responses post ECP using innovative technology such as single-cell RNA sequencing (scRNAseq) coupled with TCR sequencing to characterize ECP-related change in malignant cells
- measure
- Change from baseline in tumor-specific immunity
- timeFrame
- Up to 6 months post baseline
- description
- Evaluate immune responses post ECP using innovative technology such as single-cell RNA sequencing (scRNAseq) coupled with TCR sequencing to characterize ECP-related change in malignant cells
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient with an established diagnosis of Sezary syndrome (stage IVA1) 2. Patients amenable for ECP 3. The patient must have a minimum wash-out period of 3 weeks between the last dose of prior systemic therapy 4. Patients should have recovered from all adverse events related to prior therapy to ≤ grade 1 5. Signed informed consent form prior to any protocol-specific procedures. Exclusion Criteria: 1. Visceral metastasis of lymphoma 2. Concomitant administration of radiotherapy or systemic anti-cancer therapy including but not restricted to: chemotherapy, biological agents, or immunotherapy 3. Patients with known NCI CTCAE grade 3 or higher active systemic or cutaneous viral, bacterial, or fungal infection. 4. Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment and/or comply with study protocol. 5. Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent document. 6. Patients with known allergy to Methoxsalen or heparin (as part of SOC ECP procedure). 7. Patients who are pregnant. -
References
Publications (4)
- BACKGROUNDYing Z, Shiue L, Park K, Kollet J, Bijani P, Goswami M, Duvic M, Ni X. Blood transcriptional profiling reveals IL-1 and integrin signaling pathways associated with clinical response to extracorporeal photopheresis in patients with leukemic cutaneous T-cell lymphoma. Oncotarget. 2019 May 7;10(34):3183-3197. doi: 10.18632/oncotarget.26900. eCollection 2019 May 7. PMID 31139332
- BACKGROUNDZic JA. Extracorporeal Photopheresis in the Treatment of Mycosis Fungoides and Sezary Syndrome. Dermatol Clin. 2015 Oct;33(4):765-76. doi: 10.1016/j.det.2015.05.011. Epub 2015 Jul 29. PMID 26433848
- BACKGROUNDSpary LK, Al-Taei S, Salimu J, Cook AD, Ager A, Watson HA, Clayton A, Staffurth J, Mason MD, Tabi Z. Enhancement of T cell responses as a result of synergy between lower doses of radiation and T cell stimulation. J Immunol. 2014 Apr 1;192(7):3101-10. doi: 10.4049/jimmunol.1302736. Epub 2014 Mar 5. PMID 24600032
- BACKGROUNDCurion F, Handel AE, Attar M, Gallone G, Bowden R, Cader MZ, Clark MB. Targeted RNA sequencing enhances gene expression profiling of ultra-low input samples. RNA Biol. 2020 Dec;17(12):1741-1753. doi: 10.1080/15476286.2020.1777768. Epub 2020 Jun 28. PMID 32597303