A Study of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 9MW3011 in Patients With Polycythemia Vera

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMabwell (Shanghai) Bioscience Co., Ltd.

About this trial

The goal of this clinical trial is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of 9MW3011 in Chinese patients with Polycythemia Vera(PV).

Eligibility criteria

Qualifiers

Male and female patients aged 18 years or older at the time of screening.

A confirmed diagnosis of PV according to the revised 2016 World Health Organization criteria and are resistant to or intolerant of hydroxyurea or Interferon alpha.

Have a treatment history for PV with resistance or intolerance to hydroxyurea or Interferon alpha.

Subjects receiving hydroxyurea, Interferon alpha, or ruxolitinib must complete a washout period before administration of the investigational drug.

Disqualifiers

The spleen is palpable at least 5 centimeters below the left costal margin upon palpation at baseline.

Heart failure, unstable angina pectoris, myocardial infarction, and other thrombotic diseases within the 6 months prior to screening.

Abnormal QTc interval of electrocardiogram within the 6 months prior to screening.

Uncontrolled hypertension prior to screening.

Trial design

Treatments tested in this trial

  • 9MW3011

Treatment groups

108 Participants
are divided into 3 treatment groups

Locations

6
Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital ZhengzhouHenan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology WuhanHubei, China
The First Affiliated Hospital of Nanchang University NanchangJiangxi, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College TianjinTianjin Municipality, China

Sponsors and collaborators

Mabwell (Shanghai) Bioscience Co., Ltd.

Lead sponsor