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New treatment option for Beta-Thalassemia
Official title A Multiple Ascending Dose Study of 9MW3011 in Patients With Non-transfusion-dependent β-thalassemia
ClinicalTrials.gov ID: NCT06772766
What this study is testing
What is 9MW3011?
9MW3011 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for beta-thalassemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 .
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Male and female people aged 18 to 65 years (inclusive)
- Subject must have a documented genetic diagnosis of β-thalassemia or hemoglobin E/ β-thalassemia
- people must meet the criteria for non-transfusion-dependent thalassemia
- people 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...
- people must have evidence of iron overload during screening
You likely can't join if
- people diagnosed with alpha-thalassemia
- people diagnosed with HbS/beta-thalassemia or transfusion-dependent beta-thalassemia
- people exhibit severe iron overload at the time of screening
- In addition to thalassemia, people have any other forms of anemia and hematological disorders that the investigator assesses may compromise safety or...
- Combined with any significant systemic diseases or psychiatric disorders
- people have New York Heart Association (NYHA) Class III-IV heart failure and other cardiovascular diseases within 6 months prior to screening or...
See the full eligibility criteria
- Male and female people aged 18 to 65 years (inclusive)
- Subject must have a documented genetic diagnosis of β-thalassemia or hemoglobin E/ β-thalassemia
- people must meet the criteria for non-transfusion-dependent thalassemia
- people 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
- people must have evidence of iron overload during screening
- Subject must have performance status: Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1
- people must fully understand the study procedures and methods, voluntarily participate in the trial, and sign an informed consent form Key
- people diagnosed with alpha-thalassemia
- people diagnosed with HbS/beta-thalassemia or transfusion-dependent beta-thalassemia
- people exhibit severe iron overload at the time of screening
- In addition to thalassemia, people have any other forms of anemia and hematological disorders that the investigator assesses may compromise safety or influence study outcomes
- Combined with any significant systemic diseases or psychiatric disorders
- people have New York Heart Association (NYHA) Class III-IV heart failure and other cardiovascular diseases within 6 months prior to screening or currently present
- During the screening or baseline period, people 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
- Uncontrolled hypertension before screening
- A history of malignant neoplasm occurring within the last five years
- Severe infection requiring hospitalization or intravenous antimicrobial therapy, or uncontrolled systemic bacterial, fungal, or viral active infection
- Subject have received concomitant treatment that was not permitted by the protocol
- people whose hematological parameters did not meet the inclusion criteria during screening
- people with a history of substance abuse, as well as those who yield positive results on substance abuse screening
- people who are unable to undergo MRI scans
- Pregnant or lactating women
- people presenting any other factors deemed unsuitable for participation assessed by the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Nanning, Guangxi, China
- Haikou, Hainan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanning, Guangxi, China; Haikou, Hainan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.