NCT05203679

A Phase 1/2/3 Open-label Study to Evaluate the Safety, Tolerability and Efficacy of an Adeno-associated Virus Vector Containing an Expression Cassette of the Human Factor IX Transgene (BBM-H901) Injection in Patients With Hemophilia B

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-H901 injection in Hemophilia B subjects with ≤2 International unit per deciliter (IU/dl) residual factor IX (FIX) levels. BBM-H901 is an adeno-associated virus (AAV) vector derived from recombinant DNA techniques to contain an expression cassette of the human factor IX (hFIX) transgene and raises circulating levels of endogenous FIX.

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Interventions

Single dose intravenous injection of BBM-H901GENETIC
Single dose intravenous infusion of BBM-H901, an adeno-associated virus (AAV) vector derived from recombinant DNA techniques to contain an expression cassette of the human factor IX (hFIX) transgene in liver.

Study Locations

FacilityCityStateCountry
Anhui Provincial HospitalHefeiAnhuiChina
Peking Union Medical College HospitalBeijingBeijing MunicipalityChina
Nanfang Hospital Southern Medical UniversityGuangzhouGuangdongChina
The Second People's Hospital of ShenzhenShenzhenGuangdongChina
North China University of Science and Technology Affiliated HospitalTangshanHebeiChina
Henan Cancer HospitalZhengzhouHenanChina
The Second Hospital of Shanxi Medical UniversityTaiyuanShanxiChina
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