Long-term Follow-up Study of BHC001 for TDT

Bioray Laboratories6 enrolled

Overview

Observe long-term safety risk and long-term efficacy after intravenous infusion of BHC001 in TDT subjects.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Thalassemia, Beta

Interventions

AssessmentsOTHER

Safety and efficacy assessments

Eligibility

Sex: ALLMin age: 5 YearsMax age: 35 Years

Medical Language ↔ Plain English

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

Locations (2)

The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army

Nanning, Guangxi, China

RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

Outcomes

Primary Outcomes

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

Central Contacts

Xiaochen Wang, PhD

CONTACT

021-64340008 xcwang@brlmed.com

Data from ClinicalTrials.gov

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