Polycythemia VeraPhase 1NCT06752746
A Study of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 9MW3011 in Patients With Polycythemia Vera
A Phase 1 study testing 9MW3011 in people with Polycythemia Vera, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 6 sites in China.
Trial 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）. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polycythemia Vera
- What is being tested?
- 9MW3011
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 6 sitesChina
- Study dates
- 21 Mar 2024to 30 Jun 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 25Show fewer
- 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.
- Subjects 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Huang, 13588010568, househuang@zju.edu.cn
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Wang, 13798127917, wangjieyu19@aliyun.com
- Recruiting
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Tianjin, Tianjin Municipality
Xiao, 022-23909184, zjxiao@ihcames.ac.cn
- Recruiting
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality
Bai, 13820525296, janebai86@126.com
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Zhang, 15871818568, Zhangmin35@aliyun.com
- Recruiting
Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital
Zhengzhou, Henan
Zhou, 13939068863, papertigerhu@163.com
About this study
Official title: 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）.
Read the 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.
- Conditions
- Polycythemia Vera
- Being tested
- 9MW3011
- Medical subject headings
- Polycythemia Vera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9MW3011Drug
Multiple dose
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Open-label 9MW3011 Dose1 | Experimental | Drug: 9MW3011 9MW3011 for multiple dose via intravenous infusion Receives: Drug: 9MW3011 |
| Experimental: Open-label 9MW3011 Dose2 | Experimental | Drug: 9MW3011 9MW3011 for multiple dose via intravenous infusion Receives: Drug: 9MW3011 |
| Experimental: Open-label 9MW3011 Dose3 | Experimental | Drug: 9MW3011 9MW3011 for multiple dose via intravenous infusion Receives: Drug: 9MW3011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event
Incidence of adverse events
Measured: Up to 141 or 197 days
Vital sign
Incidence of treatment-emergent clinically abnormal vital signs
Measured: Up to 141 or 197 days
Physical examination
Incidence of treatment-emergent clinically abnormal physical examinations
Measured: Up to 141 or 197 days
12-lead electrocardiogram (ECG)
Incidence of treatment-emergent clinically significant 12-lead electrocardiograms (ECGs)
Measured: Up to 141 or 197 days
Laboratory test result
Incidence of treatment-emergent clinically significant laboratory test results
Measured: Up to 141 or 197 days
Secondary outcomes (20)
Cmax
Plasma maximum measured drug concentration
Measured: Day 1 to Day 141 or 197
Tmax
Time of maximum concentration
Measured: Day 1 to Day 141 or 197
AUC0-τ
Area under the plasma concentration-time curve during a dosage interval（τ）
Measured: Day 1 to Day 141 or 197
AUC0-t
Area under the concentration-time curve from dosing to the last measurable time point
Measured: Day 1 to Day 141 or 197
AUC0-∞
Area under the concentration-time curve from dosing to infinity
Measured: Day 1 to Day 141 or 197
λz
Terminal elimination rate constant
Measured: Day 1 to Day 141 or 197
t1/2z
The terminal elimination half-life
Measured: Day 1 to Day 141 or 197
MRT
Mean residence time
Measured: Day 1 to Day 141 or 197
Vss
Volume of Distribution at Steady State
Measured: Day 1 to Day 141 or 197
CLss
Steady-state clearance
Measured: Day 1 to Day 141 or 197
DF
Fluctuation percentage
Measured: Day 1 to Day 141 or 197
Ctrough
Trough Concentration
Measured: Day 1 to Day 141 or 197
Rac(AUC)
Accumulation ratio calculated from the AUCτ,ss and AUCτ after single dosing
Measured: Day 1 to Day 141 or 197
Rac(cmax)
Accumulation ratio calculated from the Cmax,ss and Cmax after single dosing
Measured: Day 1 to Day 141 or 197
Hepcidin
Change from baseline in hepcidin levels
Measured: Day 1 to Day 141 or 197
Serum iron
Change from baseline in serum iron levels
Measured: Day 1 to Day 141 or 197
Transferrin saturation (TSAT)
Change from baseline in transferrin saturation (TSAT) levels
Measured: Day 1 to Day 141 or 197
Anti-drug antibodies(ADA)
The incidence of ADA
Measured: Day 1 to Day 141 or 197
Hematocrit (HCT)
Change from baseline in HCT levels
Measured: 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
Measured: Day 1 to Day 141 or 197
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start21 Mar 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycythemia VeraStudies of the same condition, open and under way.
- More trials run by Mabwell (Shanghai) Bioscience Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752746
- Sponsor's protocol ID
- 9MW3011-C03
- Status last verified
- May 2025
- First submitted
- 23 Dec 2024
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06752746
- Acronym / sponsor ID
- 9MW3011-C03
- Conditions
- Polycythemia Vera
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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）.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: Open-label 9MW3011 Dose1 | Experimental | Drug: 9MW3011Drug: 9MW3011 9MW3011 for multiple dose via intravenous infusion |
| Experimental: Open-label 9MW3011 Dose2 | Experimental | Drug: 9MW3011Drug: 9MW3011 9MW3011 for multiple dose via intravenous infusion |
| Experimental: Open-label 9MW3011 Dose3 | Experimental | Drug: 9MW3011Drug: 9MW3011 9MW3011 for multiple dose via intravenous infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (25 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 9MW3011Multiple dose | Drug | Experimental: Open-label 9MW3011 Dose1, Experimental: Open-label 9MW3011 Dose2, Experimental: Open-label 9MW3011 Dose3 |
Primary outcome
Adverse Event
Time frame: Up to 141 or 197 days
Incidence of adverse events
Vital sign
Time frame: Up to 141 or 197 days
Incidence of treatment-emergent clinically abnormal vital signs
Physical examination
Time frame: Up to 141 or 197 days
Incidence of treatment-emergent clinically abnormal physical examinations
12-lead electrocardiogram (ECG)
Time frame: Up to 141 or 197 days
Incidence of treatment-emergent clinically significant 12-lead electrocardiograms (ECGs)
Laboratory test result
Time frame: Up to 141 or 197 days
Incidence of treatment-emergent clinically significant laboratory test results
20 secondary outcomes
Cmax
Time frame: Day 1 to Day 141 or 197
Tmax
Time frame: Day 1 to Day 141 or 197
AUC0-τ
Time frame: Day 1 to Day 141 or 197
AUC0-t
Time frame: Day 1 to Day 141 or 197
AUC0-∞
Time frame: Day 1 to Day 141 or 197
λz
Time frame: Day 1 to Day 141 or 197
t1/2z
Time frame: Day 1 to Day 141 or 197
MRT
Time frame: Day 1 to Day 141 or 197
Vss
Time frame: Day 1 to Day 141 or 197
CLss
Time frame: Day 1 to Day 141 or 197
DF
Time frame: Day 1 to Day 141 or 197
Ctrough
Time frame: Day 1 to Day 141 or 197
Rac(AUC)
Time frame: Day 1 to Day 141 or 197
Rac(cmax)
Time frame: Day 1 to Day 141 or 197
Hepcidin
Time frame: Day 1 to Day 141 or 197
Serum iron
Time frame: Day 1 to Day 141 or 197
Transferrin saturation (TSAT)
Time frame: Day 1 to Day 141 or 197
Anti-drug antibodies(ADA)
Time frame: Day 1 to Day 141 or 197
Hematocrit (HCT)
Time frame: Day1 to Day 141 or 197
Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score（MPN-SAF TSS）
Time frame: Day 1 to Day 141 or 197
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
Related trials for Polycythemia Vera
RecruitingPhase 3
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF)
RecruitingPhase 2/3
A Clinical Trial of Bomedemstat in Participants With Polycythemia Vera (MK-3543-025).
Polycythemia Vera
RecruitingPhase 2
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
Primary Myelofibrosis, Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
RecruitingPhase 2
A Study of Ropeg-Interferon in People With Polycythemia Vera
Polycythemia Vera (PV), JAK2 Mutation
Active, not recruitingPhase 2
A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV)
Polycythemia Vera (PV)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital
Zhengzhou, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 9MW3011 in people with Polycythemia Vera, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event (time frame: Up to 141 or 197 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.