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A Multiple Ascending Dose Study of 9MW3011 in Patients With Non-transfusion-dependent β-thalassemia | Clinical Trials | Clareo Health

RECRUITINGPHASE1

A Multiple Ascending Dose Study of 9MW3011 in Patients With Non-transfusion-dependent β-thalassemia

A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 9MW3011 in Patients With Non-transfusion-dependent β- Thalassemia

NCT06772766•Mabwell (Shanghai) Bioscience Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a phase Ib, randomized, double-blind, placebo-controlled, multiple ascending dose study . The objectives of the study are to evaluate the safety , tolerability, pharmacokinetics(PK), pharmacodynamics(PD), and immunogenicity of 9MW3011 in patients with non-transfusion-dependent β- thalassemia .

Detailed Description

A total of 40 subjects diagnosed with non-transfusion-dependent β-thalassemia will be enrolled in this study and assigned into four dosage cohorts. In each cohort, subjects will be randomized in a 4:1 ratio to receive 9MW3011 or placebo via intravenous infusion.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male and female subjects aged 18 to 65 years (inclusive)
•2. Subject must have a documented genetic diagnosis of β-thalassemia or hemoglobin E/ β-thalassemia
•3. Subjects must meet the criteria for non-transfusion-dependent thalassemia
•4. Subjects must have a baseline hemoglobin level between 70-100 g/L(inclusive), based on 2 consecutive measurements taken at least 1 week apart within 4 weeks before randomization
•5. Subjects must have evidence of iron overload during screening
•6. Subject must have performance status: Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1
•7. Subjects must fully understand the study procedures and methods, voluntarily participate in the trial, and sign an informed consent form
•13. Subjects with a history of substance abuse, as well as those who yield positive results on substance abuse screening
•14. Subjects who are unable to undergo MRI scans
•15. Pregnant or lactating women
+1 more criteria

Exclusion Criteria

•1. Subjects diagnosed with alpha-thalassemia
•2. Subjects diagnosed with HbS/beta-thalassemia or transfusion-dependent beta-thalassemia
•3. Subjects exhibit severe iron overload at the time of screening
•4. In addition to thalassemia, subjects have any other forms of anemia and hematological disorders that the investigator assesses may compromise safety or influence study outcomes
•5. Combined with any significant systemic diseases or psychiatric disorders
•6. Subjects have New York Heart Association (NYHA) Class III-IV heart failure and other cardiovascular diseases within 6 months prior to screening or currently present
•7. During the screening or baseline period, subjects exhibiting a QTcF interval of ≥450ms for males and ≥470ms for females on a 12-lead electrocardiogram (ECG), or presenting an abnormal 12-lead ECG with clinical significance
•8. Uncontrolled hypertension before screening
•9. A history of malignant neoplasm occurring within the last five years
•10. Severe infection requiring hospitalization or intravenous antimicrobial therapy, or uncontrolled systemic bacterial, fungal, or viral active infection
+1 more criteria

Locations (2)

The first Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Hainan General Hospital

Haikou, Hainan, China

Key Dates

Start Date

December 30, 2024

Primary Completion Date

October 1, 2026

Completion Date

October 1, 2026

Last Updated

January 14, 2025

Enrollment

ESTIMATED participants

Conditions

Beta-Thalassemia

Interventions

9MW3011

DRUG

9MW3011 placebo

DRUG

Contacts

Yongrong Lai

CONTACT

+8607715356304 laiyongrong@hotmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Multiple Ascending Dose Study of 9MW3011 in Patients With Non-transfusion-dependent β-thalassemia

Inclusion Criteria

Exclusion Criteria

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