NCT06752746 A Study of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 9MW3011 in Patients With Polycythemia Vera
| NCT ID | NCT06752746 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Mabwell (Shanghai) Bioscience Co., Ltd. |
| Condition | Polycythemia Vera |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2024-03-21 |
| Primary Completion | 2025-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 108 participants in total. It began in 2024-03-21 with a primary completion date of 2025-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. Male and female patients aged 18 years or older at the time of screening. 2. 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. 3. Have a treatment history for PV with resistance or intolerance to hydroxyurea or Interferon alpha. 4. Subjects receiving hydroxyurea, Interferon alpha, or ruxolitinib must complete a washout period before administration of the investigational drug. 5. Must agree to adhere to appropriate contraception requirements during the study period. 6. All female subjects with fertility capacity tested negative for blood pregnancy. 7. Voluntarily participate in clinical trials and agrees to participate in the study by giving written informed consent. Exclusion Criteria: 1. The spleen is palpable at least 5 centimeters below the left costal margin upon palpation at baseline. 2. Heart failure, unstable angina pectoris, myocardial infarction, and other thrombotic diseases within the 6 months prior to screening. 3. Abnormal QTc interval of electrocardiogram within the 6 months prior to screening. 4. Uncontrolled hypertension prior to screening. 5. Any non-PV myeloproliferative neoplasms (MPN). 6. Blast cells and blast granulocytes in the peripheral blood within the 3 months prior to screening. 7. Hematological indicators do not meet the requirements at the time of screening. 8. Known positive for active hepatitis B, hepatitis C, syphilis or human immunodeficiency virus (HIV) infection. 9. History of invasive malignancies within the last 5 years. 10. Severe infection or uncontrolled active infection. 11. Other hematological and lymphatic system diseases or any diseases causing hemolysis or erythrocyte instability. 12. 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. 13. Specific history of allergies. 14. Subjects who have used monoclonal antibodies within the 6 months prior to screening. 15. Patients who have received vaccinations within 6 weeks prior to screening. 16. Subjects who have received other antitumor therapeutic drugs for PV prior to screening. 17. Chronic diseases requiring treatment with systemic glucocorticoids or other immunosuppressants. 18. History of drug abuse or illicit drug use within 3 months prior to screening. 19. Participation in other clinical trials within 3 months prior to screening. 20. Planned elective surgery during the study. 21. History of surgery within 3 months prior to screening. 22. Intolerable iron deficiency-related symptoms judged by the investigator prior to the first dosing. 23. Pregnant or lactating females; women of reproductive age who are not using effective contraception. 24. Individuals directly associated with the research and/or their immediate family members. 25. Other factors which may potentially affect the assessment of the study results by the investigator.
Frequently Asked Questions
Who can join the NCT06752746 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Polycythemia Vera. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06752746 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06752746 currently recruiting?
Yes, NCT06752746 is actively recruiting participants. Visit ClinicalTrials.gov or contact Mabwell (Shanghai) Bioscience Co., Ltd. to inquire about joining.
Where is the NCT06752746 trial being conducted?
This trial is being conducted at Zhengzhou, China, Wuhan, China, Nanchang, China, Tianjin, China and 2 additional locations.
Who is sponsoring the NCT06752746 clinical trial?
NCT06752746 is sponsored by Mabwell (Shanghai) Bioscience Co., Ltd.. The trial plans to enroll 108 participants.