Actively Recruiting
A Study of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 9MW3011 in Patients With Polycythemia Vera
Led by Mabwell (Shanghai) Bioscience Co., Ltd. · Updated on 2025-05-11
108
Participants Needed
6
Research Sites
118 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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）.
CONDITIONS
Official Title
A Study of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 9MW3011 in Patients With Polycythemia Vera
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients aged 18 years or older at the time of screening.
- Confirmed diagnosis of Polycythemia Vera according to the revised 2016 World Health Organization criteria.
- Resistance or intolerance to hydroxyurea or Interferon alpha treatments.
- Must complete a washout period if currently receiving hydroxyurea, Interferon alpha, or ruxolitinib before starting the study drug.
- Agree to follow contraception requirements during the study.
- Female subjects with fertility potential must test negative for pregnancy.
- Voluntarily agree to participate and provide written informed consent.
You will not qualify if you...
- Palpable spleen at least 5 centimeters below the left costal margin at baseline.
- History of heart failure, unstable angina, myocardial infarction, or other thrombotic diseases within 6 months prior to screening.
- Abnormal QTc interval on electrocardiogram within 6 months prior to screening.
- Uncontrolled hypertension before screening.
- Diagnosis of any non-Polycythemia Vera myeloproliferative neoplasms.
- Presence of blast cells or blast granulocytes in peripheral blood within 3 months prior to screening.
- Hematological values not meeting requirements at screening.
- Known active infections including hepatitis B, hepatitis C, syphilis, or HIV.
- History of invasive cancers within the past 5 years.
- Severe or uncontrolled active infections.
- Other blood or lymphatic system diseases causing hemolysis or red blood cell instability.
- Systemic diseases or family history affecting safety or study results as judged by the investigator.
- Known allergy history relevant to the study.
- Use of monoclonal antibodies within 6 months prior to screening.
- Received vaccinations within 6 weeks prior to screening.
- Prior treatment with other antitumor drugs for Polycythemia Vera before screening.
- Chronic diseases requiring systemic glucocorticoids or immunosuppressants.
- History of drug abuse within 3 months prior to screening.
- Participation in other clinical trials within 3 months prior to screening.
- Planned elective surgery during the study period.
- Surgery history within 3 months prior to screening.
- Intolerable iron deficiency symptoms before first dosing.
- Pregnant or lactating females; women of reproductive age not using contraception.
- Individuals involved directly with the study or their immediate family members.
- Other factors potentially affecting study assessments as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
2
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
3
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Actively Recruiting
4
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Tianjin, Tianjin Municipality, China
Actively Recruiting
5
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
Actively Recruiting
6
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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