NCT07047885

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cutaneous T Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Ropeginterferon alfa-2b	Will be administered via subcutaneous injection once every 2 weeks

Timeline

• Start date: 2025-08-27
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2025-07-02
• Last updated: 2026-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study