Status:
RECRUITING
Study of Safety and Efficacy of MY008211A in Patients With Residual Anemia Despite Anti-C5 Antibody Treatment
Lead Sponsor:
Wuhan Createrna Science and Technology Co., Ltd
Conditions:
Paroxysmal Nocturnal Hemoglobinuria
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The main purpose of this study is to evaluate the efficacy of MY008211A in PNH patients with residual anemia despite treatment with anti-C5 antibody.
Detailed Description
This is a multicenter, single-arm, open-label phase III clinical trial. The purpose of this study is to determine whether MY008211A is efficacious and safe for the treatment of PNH patients Who Are St...
Eligibility Criteria
Inclusion
- 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%.
- Stable regimen of anti-C5 antibody treatment for at least 6 months before treatment, and Hb was still \< 100 g/L.
- The average hemoglobin level of at least two tests in 4 months before screening \< 100 g/L.
- The average hemoglobin level of two tests in the central laboratory during screening \< 100 g/L.
- 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
- Patients with reticulocytes \<100x10\^9/L; platelets \<30x10\^9/L; neutrophils \<0.5x10\^9/L.
- History of recurrent invasive infections caused by encapsulated organisms,e.g. meningococcus or pneumococcus.
- Known or suspected hereditary complement deficiency.
- Previous bone marrow or hematopoietic stem cell transplantation.
- Previous splenectomy.
- 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.
Key Trial Info
Start Date :
August 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06932471
Start Date
August 30 2024
End Date
December 30 2025
Last Update
May 9 2025
Active Locations (1)
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1
Peking Union Medical College Hospital (PUMCH).
Beijing, Beijing Municipality, China, 100032