Observe long-term safety risk and long-term efficacy after intravenous infusion of BHC001 in TDT subjects.
Eligibility
Sex
ALL
Min age
5 Years
Max age
35 Years
Healthy volunteers
No
Inclusion Criteria:
1. Provision of written informed consent for this study by subjects, or as applicable, subject's parent(s)/legal guardian(s)
2. Treated with BRL-101 for therapy of transfusion-dependent β-thalassemia.
Exclusion Criteria:
\- There are no exclusion criteria for this study
Primary outcome measure(s)
Incidence of hematologic malignancies — Up to 15 years post-drug product infusion Such as new lymphoma, leukemia, MDS, etc.
Frequency, grade, and relationship of SAEs — Within 2 years to 5years after BRL-101 Infusion Frequency, grade, and relationship to BRL-101 of SAEs following BRL-101 reinfusion
Trial sites (2)
Facility
City
Region
Status
The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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