Ropeginterferon in Patients w/Cutaneous T-Cell Lymphoma (CTCL)
NCT07047885 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2026-04-01
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
Interventions
- DRUG
-
Ropeginterferon alfa-2b
Will be administered via subcutaneous injection once every 2 weeks
Sponsors & Collaborators
-
PharmaEssentia
collaborator INDUSTRY -
H. Lee Moffitt Cancer Center and Research Institute
lead OTHER
Principal Investigators
-
Yumeng Zhang, MD · Moffitt Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-27
- Primary Completion
- 2028-06-30
- Completion
- 2028-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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