A Study of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 9MW3011 in Patients With 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

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）.

Study Overview

• Status: Recruiting
• Conditions: Polycythemia Vera
• Intervention / Treatment: Drug: 9MW3011

Detailed Description

The multiple dose fo the starting dose cohorts will comprise 3 dose cohorts of 8 PV subjects each.In each cohort, subjects will receive 9MW3011 via intravenous infusion.A decision on whether to proceed with case expansion and dose escalation will be based on the safety and PK-PD data.

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital
      • Contact: Zhou; Phone Number: 13939068863; Email: papertigerhu@163.com
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Zhang; Phone Number: 15871818568; Email: Zhangmin35@aliyun.com
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Recruiting
      • The First Affiliated Hospital of Nanchang University
      • Contact: Wang; Phone Number: 13798127917; Email: wangjieyu19@aliyun.com
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
      • Contact: Xiao; Phone Number: 022-23909184; Email: zjxiao@ihcames.ac.cn
    • Tianjin, Tianjin, China
      • Recruiting
      • The Second Hospital Of Tianjin Medical University
      • Contact: Bai; Phone Number: 13820525296; Email: janebai86@126.com
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • The First Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Huang; Phone Number: 13588010568; Email: househuang@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Open-label 9MW3011 Dose1; Drug: 9MW3011 9MW3011 for multiple dose via intravenous infusion	Drug: 9MW3011; Multiple dose
Experimental: Experimental: Open-label 9MW3011 Dose2; Drug: 9MW3011 9MW3011 for multiple dose via intravenous infusion	Drug: 9MW3011; Multiple dose
Experimental: Experimental: Open-label 9MW3011 Dose3; Drug: 9MW3011 9MW3011 for multiple dose via intravenous infusion	Drug: 9MW3011; Multiple dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event	Incidence of adverse events	Up to 141 or 197 days
Vital sign	Incidence of treatment-emergent clinically abnormal vital signs	Up to 141 or 197 days
Physical examination	Incidence of treatment-emergent clinically abnormal physical examinations	Up to 141 or 197 days
12-lead electrocardiogram (ECG)	Incidence of treatment-emergent clinically significant 12-lead electrocardiograms (ECGs)	Up to 141 or 197 days
Laboratory test result	Incidence of treatment-emergent clinically significant laboratory test results	Up to 141 or 197 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Plasma maximum measured drug concentration	Day 1 to Day 141 or 197
Tmax	Time of maximum concentration	Day 1 to Day 141 or 197
AUC0-τ	Area under the plasma concentration-time curve during a dosage interval（τ）	Day 1 to Day 141 or 197
AUC0-t	Area under the concentration-time curve from dosing to the last measurable time point	Day 1 to Day 141 or 197
AUC0-∞	Area under the concentration-time curve from dosing to infinity	Day 1 to Day 141 or 197
λz	Terminal elimination rate constant	Day 1 to Day 141 or 197
t1/2z	The terminal elimination half-life	Day 1 to Day 141 or 197
MRT	Mean residence time	Day 1 to Day 141 or 197
Vss	Volume of Distribution at Steady State	Day 1 to Day 141 or 197
CLss	Steady-state clearance	Day 1 to Day 141 or 197
DF	Fluctuation percentage	Day 1 to Day 141 or 197
Ctrough	Trough Concentration	Day 1 to Day 141 or 197
Rac(AUC)	Accumulation ratio calculated from the AUCτ,ss and AUCτ after single dosing	Day 1 to Day 141 or 197
Rac(cmax)	Accumulation ratio calculated from the Cmax,ss and Cmax after single dosing	Day 1 to Day 141 or 197
Hepcidin	Change from baseline in hepcidin levels	Day 1 to Day 141 or 197
Serum iron	Change from baseline in serum iron levels	Day 1 to Day 141 or 197
Transferrin saturation (TSAT)	Change from baseline in transferrin saturation (TSAT) levels	Day 1 to Day 141 or 197
Anti-drug antibodies(ADA)	The incidence of ADA	Day 1 to Day 141 or 197
Hematocrit (HCT)	Change from baseline in HCT levels	Day1 to Day 141 or 197
Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score（MPN-SAF TSS）	Change from baseline in MPN-SAF TSS score	Day 1 to Day 141 or 197

Collaborators and Investigators

• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2024
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 23, 2024
• First Submitted That Met QC Criteria: December 23, 2024
• First Posted (Actual): December 31, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Bone Marrow Diseases; Myeloproliferative Disorders; Bone Marrow Neoplasms; Hematologic Neoplasms; Polycythemia Vera; Polycythemia
• Other Study ID Numbers: 9MW3011-C03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No