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

NCT06752746 | Recruiting Phase 1 DMC

• 1 other identifier: 9MW3011-C03
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 6

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）.

Conditions

Polycythemia Vera

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (20)

• Cmax

  Day 1 to Day 141 or 197

• Tmax

  Day 1 to Day 141 or 197

• AUC0-τ

  Day 1 to Day 141 or 197

• AUC0-t

  Day 1 to Day 141 or 197

• AUC0-∞

  Day 1 to Day 141 or 197

Study Arms (3)

Experimental: Open-label 9MW3011 Dose1

EXPERIMENTAL

Drug: 9MW3011 9MW3011 for multiple dose via intravenous infusion

Drug: 9MW3011

Experimental: Open-label 9MW3011 Dose2

EXPERIMENTAL

Drug: 9MW3011 9MW3011 for multiple dose via intravenous infusion

Drug: 9MW3011

Experimental: Open-label 9MW3011 Dose3

EXPERIMENTAL

Drug: 9MW3011 9MW3011 for multiple dose via intravenous infusion

Drug: 9MW3011

Interventions

9MW3011 DRUG

Multiple dose

Experimental: Open-label 9MW3011 Dose1; Experimental: Open-label 9MW3011 Dose2; Experimental: Open-label 9MW3011 Dose3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 Interferon alpha.
• Have a treatment history for PV with resistance or intolerance to hydroxyurea or Interferon alpha.
• Subjects 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 subjects 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.

You may not qualify 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.
• 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.
• Subjects who have used monoclonal antibodies within the 6 months prior to screening.
• Patients who have received vaccinations within 6 weeks prior to screening.

Sponsors & Collaborators

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

Study Sites (6)

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

MeSH Terms

Conditions

Polycythemia Vera

Condition Hierarchy (Ancestors)

Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Myeloproliferative Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: December 31, 2024
• Study Start: March 21, 2024
• Primary Completion: August 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

CN (6)