Observe long-term safety risk and long-term efficacy after intravenous infusion of BRL-101 in TDT subjects.
Observe long-term delayed safety risks such as emerging neoplasms, emerging haematological disorders, and long-term efficacy after intravenous infusion of BRL-101 in TDT subjects.
Study Type
OBSERVATIONAL
Enrollment
45
Safety and efficacy assessments
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
ACTIVE_NOT_RECRUITINGSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGShenzhen Children 's Hospital
Shenzhen, Guangdong, China
Incidence of hematologic malignancies
Such as new lymphoma, leukemia, MDS, etc.
Time frame: Up to 15 years post-drug product infusion
Frequency, grade, and relationship of SAEs
Frequency, grade, and relationship to BRL-101 of SAEs following BRL-101 reinfusion.
Time frame: Within 2 years to 5years after BRL-101 Infusion
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No. 923 Hospital of Joint Support Force of Chinese People 's Liberation Army Hospital
Nanning, Guangxi, China
NOT_YET_RECRUITINGXiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGTianjin Institute of Hematology
Tianjin, Tianjin Municipality, China
RECRUITINGThe First Affiliated Hospital of GUANGXI MEDICAL UNIVERSITY
Guangxi, China
RECRUITING