drugset / Trial / NCT07047885
Ropeginterferon in Patients w/Cutaneous T-Cell Lymphoma (CTCL)
Phase 1
Recruiting
38 enrolled
H. Lee Moffitt Cancer Center and Research Institute
PharmaEssentia · collab
Non-randomizedSequentialOpen-labelTreatment
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).
Timeline
- Start
- 2025-08-27
- Primary completion
- 2028-06
- Completion
- 2028-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ropeginterferon alfa-2b | Protein / enzyme biologic | 250 ug | Subcutaneous |
| Subject | Ropeginterferon alfa-2b | Protein / enzyme biologic | 350 ug | Subcutaneous |
| Subject | Ropeginterferon alfa-2b | Protein / enzyme biologic | 500 ug | Subcutaneous |