Long-term Follow-up Study of BRL-101 for TDT

Thalassemia, Beta Clinical Trial

Official title:

Long-term Follow-up Study of BRL-101 in the Treatment of Transfusion-dependent β-thalassemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06298630
• Other study ID #: 2022-LTF-BRL-101
• Status: Not yet recruiting
• Start date: December 8, 2024
• Est. completion date: October 15, 2038

Study information

• Verified date: February 2024
• Source: Bioray Laboratories
• Contact: Xiaochen Wang, phD
• Phone: 021-64340008
• Email: xcwang[@]brlmed.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observe long-term safety risk and long-term efficacy after intravenous infusion of BRL-101 in TDT subjects.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: October 15, 2038
• Est. primary completion date: August 20, 2038
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 35 Years

Eligibility

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 ß-thalassemia.

Exclusion Criteria:

• There are no exclusion criteria for this study

Related Conditions & MeSH terms

• beta-Thalassemia
• Thalassemia
• Thalassemia, Beta

Intervention

Other:
• Assessments
Safety and efficacy assessments

Locations

Country	Name	City	State
China	Xiangya Hospital of Central South University	Changsha	Hunan
China	The First Affiliated Hospital of GUANGXI MEDICAL UNIVERSITY	Guangxi
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong
China	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Guangzhou	Guangdong
China	No. 923 Hospital of Joint Support Force of Chinese People 's Liberation Army Hospital	Nanning	Guangxi
China	Shenzhen Children 's Hospital	Shenzhen	Guangdong
China	Tianjin Institute of Hematology	Tianjin	Tianjin

Sponsors (8)

Lead Sponsor	Collaborator
Bioray Laboratories	Chinese Academy of Medical Sciences, First Affiliated Hospital of Guangxi Medical University, Nanfang Hospital, Southern Medical University, Shenzhen Children 's Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army, Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hematologic malignancies	Such as new lymphoma, leukemia, MDS, etc.	Up to 15 years post-drug product infusion
Primary	Frequency, grade, and relationship of SAEs	Frequency, grade, and relationship to BRL-101 of SAEs following BRL-101 reinfusion.	Within 2 years to 5years after BRL-101 Infusion