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Tests treatment safety and results for Polycythemia Vera
Official title A Study of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 9MW3011 in Patients With Polycythemia Vera
ClinicalTrials.gov ID: NCT06752746
What this study is testing
What is 9MW3011?
9MW3011 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for polycythemia vera.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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）.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Have a treatment history for PV with resistance or intolerance to hydroxyurea or Interferon alpha.
- people receiving hydroxyurea, Interferon alpha, or ruxolitinib must complete a washout period before administration of the investigational drug.
- Must agree to adhere to appropriate contraception requirements during the study period.
You likely can't join if
- 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.
- Any non-PV myeloproliferative neoplasms (MPN).
- Blast cells and blast granulocytes in the peripheral blood within the 3 months prior to screening.
See the full eligibility criteria
- 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.
- people receiving hydroxyurea, Interferon alpha, or ruxolitinib must complete a washout period before administration of the investigational drug.
- Must agree to adhere to appropriate contraception requirements during the study period.
- All female people with fertility capacity tested negative for blood pregnancy.
- Voluntarily participate in clinical trials and agrees to participate in the study by giving written informed consent.
- 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.
- Any non-PV myeloproliferative neoplasms (MPN).
- Blast cells and blast granulocytes in the peripheral blood within the 3 months prior to screening.
- Hematological indicators do not meet the requirements at the time of screening.
- Known positive for active hepatitis B, hepatitis C, syphilis or human immunodeficiency virus (HIV) infection.
- History of invasive malignancies within the last 5 years.
- Severe infection or uncontrolled active infection.
- Other hematological and lymphatic system diseases or any diseases causing hemolysis or erythrocyte instability.
- Other systemic diseases or a family history of systemic diseases, may affect the subject's safety or any other diseases and physiological conditions that may affect the results of the study, judged by the investigator.
- Specific history of allergies.
- people who have used monoclonal antibodies within the 6 months prior to screening.
- Patients who have received vaccinations within 6 weeks prior to screening.
- people who have received other antitumor therapeutic drugs for PV prior to screening.
- Chronic diseases requiring treatment with systemic glucocorticoids or other immunosuppressants.
- History of 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.
- History of surgery within 3 months prior to screening.
- Intolerable iron deficiency-related symptoms judged by the investigator prior to the first dosing.
- Pregnant or lactating females; women of reproductive age who are not using effective contraception.
- Individuals directly associated with the research and/or their immediate family members.
- Other factors which may potentially affect the assessment of the study results by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Nanchang, Jiangxi, China
- Tianjin, Tianjin Municipality, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China; Wuhan, Hubei, China; Nanchang, Jiangxi, China; Tianjin, Tianjin Municipality, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.