NCT06285370

A Study to Evaluate the Efficacy and Safety of KW-0761 in Chinese Subjects With Mycosis Fungoides or Sézary Syndrome Previously Treated With Systemic Therapy

An Open-Label, Multicenter, Single Arm Study to Evaluate the Efficacy and Safety of Anti-CCR4 Monoclonal Antibody Mogamulizumab (KW-0761) in Chinese Subjects With Mycosis Fungoides or Sézary Syndrome Previously Treated With Systemic Therapy

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Kyowa Kirin China Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the efficacy and safety of mogamulizumab (KW-0761) in chinese subjects with mycosis fungoides or sézary syndrome previously treated with systemic therapy

Detailed description

This is an open-label, multicenter, single arm study. This study consists of three parts: the Pretreatment Period, the Treatment Period, and the Follow-up Period. Subjects who meet all of eligibility criteria by the screening examination will be enrolled into the study, and start treatment with mogamulizumab within 30 days after obtaining consent. Mogamulizumab will be administered at the dose of 1.0 mg/kg as an intravenous (iv) infusion over at least 1 hour on Days 1, 8, 15, and 22 of Cycle 1 and on Days 1 and 15 of subsequent cycles. Each treatment cycle is set as 28 days. Subjects will continue the treatment of mogamulizumab until any of the criteria for study withdrawal is met. After stopping treatment, the end-of treatment examination will be conducted within 30 days after the last dose.The primary efficacy analysis will be conducted once all subjects terminate treatment by the confirmation of PD/drug intolerance/unacceptable toxicity or 12 months after the date of the first mogamulizumab administration of the last subject of entire study, whichever comes first.

Conditions

• Cutaneous T-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Mogamulizumab	Mogamulizumab will be administered at the dose of 1.0 mg/kg as an intravenous (iv) infusion over at least 1 hour on Days 1, 8, 15, and 22 of Cycle 1 and on Days 1 and 15 of subsequent cycles. Each treatment cycle is set as 28 days. Subjects will continue the treatment of mogamulizumab until any of the criteria for study withdrawal is met.

Timeline

• Start date: 2023-05-29
• Primary completion: 2025-08-12
• Completion: 2025-11-13
• First posted: 2024-02-29
• Last updated: 2025-09-18

Locations

8 sites across 1 country: China