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

NCT06285370 | Active Not Recruiting Phase 4

• 2 other identifiers: 0761-CN001CTR20230672
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 8

Brief 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

Conditions

Cutaneous T-Cell Lymphoma

Keywords

mycosis fungoides/sézary syndrome

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  The ORR was defined as the count of subjects who had a confirmed CR or PR, defined as documented CR or PR per Global Composite Response Score that was confirmed by a subsequent observation at least 4 weeks later. Overall Response Rate was determined based on the response in all compartments (lymph nodes, skin, peripheral blood, and viscera), referencing Olsen, 2011 as follows: Complete Response (CR) = complete disappearance of all clinical evidence of disease; Partial Response (PR) = regression of measurable disease; Stable Disease (SD) = failure to attain CR, PR, or PD; Progressive Disease (PD) = PD in any compartment; Relapse = recurrence of disease in prior CR in any compartment.

  At the end of each cycle (each cycle is 28 days) until progression up to 29 months;

Secondary Outcomes (9)

• Skin disease response rate;

  At the end of each cycle (each cycle is 28 days) until progression up to 29 months;

• Lymth nodes response rate

  At the end of each cycle (each cycle is 28 days) until progression up to 29 months;

• Visceral metastases response rate;

  At the end of each cycle (each cycle is 28 days) until progression up to 29 months;

• Blood disease response rate;

  At the end of each cycle (each cycle is 28 days) until progression up to 29 months;

• Progression Free Survival

  Up to 32 months.

Other Outcomes (4)

• To evaluate pharmacokinetics (plasma mogamulizumab concentration) of mogamulizumab.

  Day 1 (Before infusion and at the end of the infusion), Day 8, Day 15, Day 22, Days 28 in Cycle 1; Day 15, Days 28 in Cycle 2 and 3; Days 28 in Cycle 4, 6, 8, 10, 12; Last visit. Each cycle is 28 days.

• To evaluate immunogenicity (anti-mogamulizumab antibody) of mogamulizumab.

  Day 1, Days 28 in Cycle 1; Days 28 in Cycle 2, 3, 4, 6, 8, 10, 12; Last visit. Each cycle is 28 days.

• To evaluate the effects of skin disease on health-related Quality of Life (HRQoL) -Skindex 29.

  Day 1, Days 28 in Cycle 1; Days 28 in odd cycles (Cycle 3, 5, 7, 9, 11, 13, 15…); Last visit. Each cycle is 28 days.

Study Arms (1)

KW-0761

EXPERIMENTAL

Patients will receive KW-0761 in this arm

Drug: Mogamulizumab

Interventions

Mogamulizumab DRUG

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.

KW-0761

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily signed and dated ethics committee (EC) approved informed consent form in accordance with regulatory and institutional guidelines. Written informed consent must be obtained prior to performing any study-related procedure.
• Male and female Chinese subjects ≥18 years of age at the time that written informed consent is obtained.
• Histologically confirmed diagnosis of MF or SS;
• Stage IB, IIA, IIB, III, and IV.
• Patients who have failed at least one prior systemic therapy. Systemic therapy includes, for example, interferon, denileukin diftitox, retinoid, photopheresis, anti-neoplastic chemotherapy, methotrexate, and Histone deacetylase (HDAC) inhibitor.
• \- Ultraviolet light therapy (Psoralen plus ultraviolet A \[PUVA\], ultraviolet B \[UVB\] etc), systemic steroid monotherapy, topical steroid or other topical agents, and any radiation are not considered to be a systemic therapy.
• Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1.
• The subject has resolution of all clinically significant toxic effects of prior cancer therapy to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE, ver. 5.0) excluding the specifications required in 8, 9, and 10 below.
• Adequate hematological function:
• absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L;
• platelets ≥ 100.0 × 10\^9/L;
• in subjects with known bone marrow involvement, ANC must be ≥ 1.0 × 10\^9/L and platelets ≥ 75.0 × 10\^9/L.
• Adequate hepatic function:
• Total bilirubin ≤ 1.5 times the specific institutional upper limit of normal (ULN);
• aspartate transaminase (AST) and alanine transaminase (ALT) each ≤ 2.5 × ULN or ≤ 5.0 × ULN in the presence of known hepatic involvement by CTCL.

You may not qualify if:

• Current evidence of large cell transformation (LCT). Patients with clinical features suggestive of LCT are recommended to have a biopsy performed within 4 months prior to Cycle 1 Day 1 to rule out transformed disease. Patients with a history of LCT but without current aggressive disease and no current evidence of LCT on pathology in skin or lymph nodes are eligible.
• Diagnosed with a malignancy other than MF/SS in the past 2 years from the time that written informed consent is obtained. However, subjects with non-melanoma skin cancers, melanoma in situ, localized cancer of the prostate with current prostate-specific antigen of \< 0.1 ng/mL, treated thyroid cancer or cervical carcinoma in situ, or ductal/lobular carcinoma in situ of the breast within the past 2 years may be enrolled as long as there is no current evidence of disease.
• Clinical evidence of central nervous system metastasis.
• Psychiatric illness, disability or social situation that would compromise the subject's safety or ability to provide consent, or limit compliance with study requirements.
• Significant uncontrolled intercurrent illness including, but not limited to:
• uncontrolled infection requiring antibiotics;
• clinically significant cardiac disease (Class III or IV of the New York Heart Association \[NYHA\] classification);
• unstable angina pectoris;
• angioplasty, stenting, or myocardial infarction within 6 months;
• uncontrolled hypertension (systolic blood pressure \[BP\] \> 160 mmHg or diastolic BP\>100 mmHg, found on 2 consecutive measurements separated by a 1-week period) despite 2 antihypertensive medications;
• clinically significant cardiac arrhythmia;
• uncontrolled diabetes.
• Known or tests positive for human immunodeficiency virus (HIV) or history of HIV infection, or hepatitis C disease or history of hepatitis C infection.
• Tests positive for hepatitis B virus surface (HBs) antigen or both HBc antibody and hepatitis B virus (HBV)-DNA positive (over the lower limit of quantification);
• \- Patients with HBs antibody positive due to a hepatitis B vaccine will be allowed to participate in this trial.

Sponsors & Collaborators

• Kyowa Kirin China Pharmaceutical Co., Ltd.: lead

Study Sites (8)

Peking University First Hospital, Department of Dermatology and Venereology

Beijing, Beijing Municipality, 100034, China

Location

Sun Yat-sen University Cancer Center, Department of Medical Oncology

Guangzhou, Guangdong, 510060, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, 010000, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110002, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610044, China

Location

ZheJiang Cancer Hospital

Hangzhou, Zhejiang, 310005, China

Location

First Affiliated Hospital of Zhengzhou University

Henan, Zhengzhou, 450052, China

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous

Interventions

mogamulizumab

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yuankai Shi

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: No Masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an open-label, multicenter, single arm study.

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: February 29, 2024
• Study Start: May 29, 2023
• Primary Completion: August 12, 2025
• Study Completion: November 13, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (8)