RecruitingPhase 1NCT07047885

Ropeginterferon in Patients w/Cutaneous T-Cell Lymphoma (CTCL)

A Phase I/IB Study of Ropeginterferon in Patients With Cutaneous T-Cell Lymphoma (CTCL)


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

38 participants

Start Date

Aug 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-center, phase I/IB study to identify the recommended phase II dose of Ropeginterferon-alfa 2b (P1101) in patients with CTCL who have failed at least two prior lines of skin-directed therapy (Stage IA-IB) or have less than a complete response to phototherapy or extracorporeal photopheresis (ECP) or total skin electron beam therapy (TSET), or stable/progressive disease after at least two lines of topical therapy (Stage IIA-IIIB).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing ropeginterferon alfa-2b (P1101), a long-acting immune-stimulating injection given every two weeks, for people with cutaneous T-cell lymphoma (CTCL) — a type of skin cancer involving immune cells — that has not responded adequately to standard skin-directed treatments. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of CTCL (including mycosis fungoides, Sézary syndrome, or lymphomatoid papulosis) - For early-stage (IA-IB): you have failed at least two prior skin-directed therapies - For later stages (IIA-IIIB): your cancer did not fully respond to phototherapy, extracorporeal photopheresis, or at least 2 topical therapies - Your thyroid function is normal or well-controlled - You have adequate blood counts and kidney/liver function **You may NOT be eligible if...** - Your cancer has large cell transformation (a more aggressive change in the tumor) - You have had systemic cancer treatment less than 3 weeks before starting the study - You are pregnant or breastfeeding - You have uncontrolled very high triglycerides or cholesterol - You cannot tolerate subcutaneous (under-skin) injections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRopeginterferon alfa-2b

Will be administered via subcutaneous injection once every 2 weeks


Locations(1)

Moffitt Cancer Center

Tampa, Florida, United States

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NCT07047885


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