Long-term Follow-up Study of BHC001 for TDT

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06314529

Enrollment

Registered

2024-03-18

Start date

2022-12-14

Completion date

2037-05-10

Last updated

2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thalassemia, Beta

Brief summary

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

Detailed 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.

Interventions

OTHERAssessments

Safety and efficacy assessments

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to 35 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactXiaochen Wang, PhD

xcwang@brlmed.com021-64340008

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026