Long-term Follow-up Study of BHC001 for TDT

Thalassemia, Beta Clinical Trial

Official title:

Long-term Follow-up Study of BHC001 in the Treatment of Transfusion-dependent β-thalassemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06314529
• Other study ID #: 2022-LTF-BHC001
• Status: Recruiting
• Start date: December 14, 2022
• Est. completion date: May 10, 2037

Study information

• Verified date: March 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 BHC001 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 BHC001 in TDT subjects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: May 10, 2037
• Est. primary completion date: December 10, 2036
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 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 923rd Hospital of Joint Logistics Support Force of People's Liberation Army	Nanning	Guangxi

Sponsors (3)

Lead Sponsor	Collaborator
Bioray Laboratories	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