Evaluating a new treatment for Polycythemia Vera

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

This study is testing a new drug for people with Polycythemia Vera who haven't had success with standard treatments to see if it's safe and effective for them.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. (Industry-sponsored)
• Drugs / interventions: ruxolitinib
• Locations: 6 sites (Zhengzhou, Henan and 5 other locations)
• Trial ID: NCT06752746 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a new drug, 9MW3011, in patients diagnosed with Polycythemia Vera (PV) who have not responded to or cannot tolerate standard treatments like hydroxyurea or Interferon alpha. The study will involve multiple dose cohorts, with each cohort consisting of 8 subjects receiving the drug via intravenous infusion. Decisions regarding further dose escalation and case expansion will be based on the collected safety and pharmacokinetic-pharmacodynamic data.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of Polycythemia Vera who have shown resistance or intolerance to hydroxyurea or Interferon alpha.

Not a fit: Patients with significant spleen enlargement or severe cardiovascular conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with Polycythemia Vera who are resistant to existing therapies.

How similar studies have performed: While this approach is novel in the context of Polycythemia Vera, similar studies evaluating new treatments for hematological conditions have shown promise.

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.

Where this trial is running

Zhengzhou, Henan and 5 other locations

• Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Tianjin, Tianjin Municipality, China (Recruiting)
• The Second Hospital of Tianjin Medical University — Tianjin, Tianjin Municipality, China (Recruiting)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Conditions Polycythemia Vera