Actively Recruiting
A Phase Ib, Multicenter, Randomized, Open-Label, Dose Escalation Study to Evaluate the 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
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of the drug 9MW3011 in Chinese patients diagnosed with Polycythemia Vera (PV). This phase 1b clinical trial aims to understand how the drug behaves in the body and its effects in patients who have shown resistance or intolerance to existing treatments like hydroxyurea or Interferon alpha. Participants will be assigned to one of three dose groups, each containing 8 patients. All subjects will receive multiple doses of 9MW3011 through intravenous infusion. Decisions about increasing the dose or expanding the number of participants will depend on the safety and pharmacokinetic/pharmacodynamic data collected during the study. Throughout the study, participants will undergo various assessments including monitoring for adverse events, vital signs, physical exams, ECGs, and laboratory tests up to 141 or 197 days. Researchers will also measure drug concentration levels and immune responses, as well as symptom scores related to PV. The trial will carefully track safety and drug effects over this period to inform further development.
CONDITIONS
Brief 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 screening
- Confirmed diagnosis of Polycythemia Vera according to 2016 WHO criteria
- Resistant or intolerant to hydroxyurea or Interferon alpha treatment
- Completed washout period if previously treated with hydroxyurea, Interferon alpha, or ruxolitinib
- Agree to use appropriate contraception during the study
- Female participants with childbearing potential must have a negative pregnancy test
- Voluntary written informed consent to participate in the study
You will not qualify if you...
- Spleen palpable at least 5 cm below the left costal margin at baseline
- Heart failure, unstable angina, myocardial infarction, or thrombotic diseases within 6 months prior to screening
- Abnormal QTc interval on electrocardiogram within 6 months prior to screening
- Uncontrolled hypertension before screening
- Any non-Polycythemia Vera myeloproliferative neoplasms
- Presence of blast cells or blast granulocytes in peripheral blood within 3 months prior to screening
- Hematological indicators not meeting requirements at screening
- Active infections including hepatitis B, hepatitis C, syphilis, or HIV
- History of invasive malignancies within last 5 years
- Severe or uncontrolled active infections
- Other hematological or lymphatic diseases causing hemolysis or erythrocyte instability
- Systemic diseases or family history affecting safety or study results
- Specific allergy history
- Use of monoclonal antibodies within 6 months prior to screening
- Vaccinations within 6 weeks prior to screening
- Prior antitumor treatments for Polycythemia Vera
- Chronic treatment with systemic glucocorticoids or immunosuppressants
- Drug abuse or illicit drug use within 3 months prior to screening
- Participation in other clinical trials within 3 months prior to screening
- Planned elective surgery during the study or surgery within 3 months prior to screening
- Intolerable iron deficiency symptoms before first dosing
- Pregnant or lactating females; women not using effective contraception
- Direct association with the research or immediate family members
- Other factors potentially affecting study assessment as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 20 to 28 weeks
Participants receive multiple doses of the study drug 9MW3011 via intravenous infusion in one of three dose cohorts.
Multiple visits for dosing and assessments over the treatment period
Duration - Up to approximately 20 to 28 weeks after treatment
Participants are monitored for safety, tolerability, and other study outcomes after treatment ends.
Regular visits for up to 20 to 28 weeks post-treatment
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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