NCT06111638

A Phase 1/2/3 Open-label Study to Evaluate the Safety, Tolerability and Efficacy of an Adeno-associated Viral Vector Containing an Expression Cassette of the Human Factor VIII Transgene (BBM-H803) Injection in Participants With Hemophilia A

Study Summary

This is a multi-center, Phase 1/2/3, single-arm, open-label, single-dose treatment clinical study to evaluate the safety, tolerability and efficacy of BBM-H803 injection in severe Hemophilia A subjects. BBM-H803 is an adeno-associated viral (AAV) vector derived from recombinant DNA techniques to contain an expression cassette of the human factor VIII transgene and raises circulating levels of endogenous FVIII.

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Interventions

Single dose intravenous injection of BBM-H803GENETIC
Single dose intravenous infusion of BBM-H803, an adeno-associated viral (AAV) vector derived from recombinant DNA techniques to contain an expression cassette of the human factor VIII transgene in liver. The dose of BBM-H803 will be calculated according to participant's weight.

Study Locations

FacilityCityStateCountry
Peking Union Medical College Hospital, Chinese Academy of Medical SciencesBeijingBeijing MunicipalityChina
Southern Hospital, Southern Medical UniversityGuangzhouGuangdongChina
Affiliated Hospital of Guizhou Medical UniversityGuiyangGuizhouChina
Wuhan Union Hospital Affiliated to Huazhong University of Science and TechnologyWuhanHubeiChina
Xiangya Hospital Central South UniversityChangshaHunanChina
The First Affiliated Hospital of Soochow UniversitySuzhouJiangsuChina
The Affiliated Hospital of Northwest University Xi'an No.3 HospitalXi’anShanxiChina
Sichuan Provincial People's HospitalChengdeSichuanChina
Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical CollegeTianjinTianjin MunicipalityChina
The Second Affiliated Hospital of Kunming Medical UniversityKunmingYunnanChina

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026