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Ropeginterferon for Cutaneous T-Cell Lymphoma

This study is testing a drug called Ropeginterferon alfa-2b for people with Cutaneous T-Cell Lymphoma (CTCL), a type of cancer that starts in white blood cells and affects the skin. You might be able to join if you are 18 or older, have been diagnosed with CTCL (specifically Mycosis Fungoides, Sézary Syndrome, Lymphomatoid Papulosis, or other rare types), and your previous treatments haven't worked well enough. The main goals of this study are to find out the highest safe dose of Ropeginterferon alfa-2b and to see if it causes any serious side effects. This information will help doctors plan future studies. The study plans to enroll 38 participants, but its current recruitment status is unclear.

Study design
This is a single-center, Phase I/IB study. It aims to identify the recommended dose for future studies.
What's involved
You will receive Ropeginterferon alfa-2b as an injection under the skin once every two weeks.
Compensation
Not stated in the trial record.
Follow-up
The main safety and dose findings will be measured at 6 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07047885

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
H. Lee Moffitt Cancer Center and Research Institute
~38 participants
Updated 2026-04-01 on ClinicalTrials.gov
What's tested:Ropeginterferon alfa-2b

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose Limiting Toxicity
Measured over 6 weeks
+1 more outcome measured

Conditions

Cutaneous T Cell Lymphoma

Explore related trials

Primary Cutaneous T-Cell Non-Hodgkin Lymphoma

NCT07047885

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Moffitt Cancer Center

    Tampa, Floridano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Yumeng Zhang, MD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

Richard Corona
[email protected]
813-745-3465
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Diagnosed with cutaneous T-cell lymphoma, stage IA-IIIB CTCL according to WHO-EORTC classification, specifically the following subtypes: Mycosis Fungoides (MF); Sézary Syndrome (SS); Lymphomatoid Papulosis (LyP) or other rare CTCL variants per WHO-EORTC classification, provided the investigator determines the disease course warrants systemic treatment.
A) For Stage IA-IB: Must have failed at least two prior lines of skin-directed therapy, where "failed" is defined as any of the following: a. Inadequate response (persistent clinically significant lesions or symptoms), b. Unacceptable toxicity, or c. Disease progression. Such patients require a systemic approach because of symptomatic, refractory, or recalcitrant disease. B) For Stage IIA-IIIB: Must have a documented less-than-complete response to phototherapy, extracorporeal photopheresis (ECP), or total skin electron beam therapy (TSET), or have failed disease after ≥2 lines of topical therapy (using the same definition of "failed" as above.
Patients are allowed to continue phototherapy or ECP at their prior schedule or a less frequent schedule. Topical therapy, phototherapy, and ECP are allowed if the patient has been on a stable dose of topical therapy or schedule of the phototherapy or ECP. Patients are not allowed to start new skin-directed therapies or escalate the frequency of the prior skin-directed therapy schedule while on the study.
Male or female, aged 18 years or older.
There is no evidence of large cell transformation on the skin biopsy at the screening visit.
Ability to take subcutaneous injection medication and be willing to adhere to the P1101 q2week injection regimen.
Minimum wash-out period of 3 weeks between the last dose of prior systemic therapy (other anti-cancer therapy aside from ECP or phototherapy) and the first dose of P1101.
Women of childbearing potential (WCBP) must have a negative serum beta-HCG pregnancy test within 7 days of receiving study medication. An WOCP is considered a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months. For WOCP and female partners of male subjects, reliable contraception methods must be used throughout the duration of treatment up to at least 8 weeks after the last dose of study drug has been administered.
Ability to understand and the willingness to sign a written informed consent document.
Acceptable Hematologic Parameters
Thyroid-stimulating hormone (TSH) within institutional normal limits OR well-controlled on thyroid replacement.
Lipid Panel: a. No severe hypertriglyceridemia (e.g., triglycerides \< 400-500 mg/dL, or medically manageable per investigator discretion). b. No uncontrolled hypercholesterolemia that is unresponsive to standard lipid lowering agents.
Renal Function: Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min using a CKD EPI.
AST/ALT \< 3 x upper limit of normal (ULN), and total bilirubin \< 2 x ULN (unless due to Gilbert's syndrome).

Exclusion

Large cell transformation at screening visit.
Child-Pugh B or C hepatic impairment of any etiology.
Uncontrolled psychiatric disorders, defined as Patient Health Questionnaire-2 (PHQ-2) depression screening score equal to or above 3.
Treatment with another investigational drug or other systemic drug within 3 weeks. Concomitant administration of radiotherapy or systemic anti-cancer therapy, including but not restricted to chemotherapy, biological agents, or immunotherapy. Concurrent use of systemic steroids is allowed in patients with erythroderma who have been on corticosteroids to avoid possible rebound flare of the disease, adrenal insufficiency, or unnecessary suffering. Concomitant phototherapy or extracorporeal photopheresis (ECP) are also allowed.
Severe or unstable cardiovascular disease (uncontrolled hypertension, heart failure (≥ NYHA class 2), serious cardiac arrhythmia, significant coronary artery stenosis, unstable angina, or recent stroke or myocardial infarction.
Active, uncontrolled HIV, detectable HBV, or active HCV infection. The patients who are stable on anti-retroviral therapy or suppressed on HBV/HCV therapy are allowed in the study.
Active, uncontrolled ophthalmic disorders such as severe retinopathy, uncontrolled glaucoma, or advanced proliferative retinopathy.
History of or active serious or uncontrolled autoimmune disease, or patients on systemic immunosuppressants or history of systemic immunosuppressants for autoimmune disease.
History of solid organ or stem cell transplantation recipients who are at heightened risk for immunologic complications on interferons.
Known hypersensitivity to interferons.
Baseline QTcF \> 470 ms.
No active, serious infection requiring systemic antimicrobial therapy at screening.
Pregnant or breastfeeding women are excluded.

What this trial measures

  • Dose Limiting Toxicity6 weeks

    The percentage of participants who experience any grade 3 or higher non-hematologic toxicity and grade 4 or higher hematologic toxicity of P1101 according to CTCAE v5.0 during the first six weeks of therapy.

  • Recommended Phase II Dose6 weeks

    The Recommended Phase II Dose will be determined according to the Bayesian optimal interval (BOIN) design.