Study of Safety and Efficacy of MY008211A in Patients With Residual Anemia Despite Anti-C5 Antibody Treatment

Launched by WUHAN CREATERNA SCIENCE AND TECHNOLOGY CO., LTD · Apr 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called MY008211A for patients with a condition called Paroxysmal Nocturnal Hemoglobinuria (PNH). PNH can cause anemia, which means your body doesn’t have enough red blood cells. This study focuses on patients who still have low hemoglobin levels (the protein in red blood cells that carries oxygen) even after receiving standard treatment with anti-C5 antibodies. The main goal is to see if MY008211A can effectively improve hemoglobin levels and overall health in these patients.

To participate in the trial, you need to be at least 18 years old and have been diagnosed with PNH. You should also have been receiving anti-C5 antibody treatment for at least six months, but still have hemoglobin levels below 100 g/L. Additionally, you must meet certain health criteria, such as having a stable weight and being up to date on vaccinations against specific infections. If you join the trial, you will be monitored closely to see how well the new treatment works and to ensure your safety. This study is currently recruiting participants, and it welcomes individuals of all genders within the specified age range.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male and female participants ≥ 18 years of age and BMI ≥ 18.0 kg/m2 with a diagnosis of PNH confirmed by high-sensitivity flow cytometry with clone size ≥ 10%.
• • 2. Stable regimen of anti-C5 antibody treatment for at least 6 months before treatment, and Hb was still \< 100 g/L.
• • 3. The average hemoglobin level of at least two tests in 4 months before screening \< 100 g/L.
• • 4. The average hemoglobin level of two tests in the central laboratory during screening \< 100 g/L.
• • 5. Vaccination against Neisseria meningitidis infection is required prior to the start of study treatment. If not received previously, vaccination against Streptococcus pneumoniae and Haemophilus influenzae infections should be given.
• Exclusion Criteria:
• • 1. Patients with reticulocytes \<100x10\^9/L; platelets \<30x10\^9/L; neutrophils \<0.5x10\^9/L.
• • 2. History of recurrent invasive infections caused by encapsulated organisms,e.g. meningococcus or pneumococcus.
• • 3. Known or suspected hereditary complement deficiency.
• • 4. Previous bone marrow or hematopoietic stem cell transplantation.
• • 5. Previous splenectomy.
• • 6. A history of malignancy within 5 years before screening, except cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.