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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06298630
Enrollment
45
Registered
2024-03-07
Start date
2024-12-08
Completion date
2038-10-15
Last updated
2026-07-21

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 BRL-101 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 BRL-101 in TDT subjects.

Interventions

OTHERAssessments

Safety and efficacy assessments

Sponsors

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

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 35 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Incidence of hematologic malignanciesUp to 15 years post-drug product infusionSuch as new lymphoma, leukemia, MDS, etc.
Frequency, grade, and relationship of SAEsWithin 2 years to 5years after BRL-101 InfusionFrequency, grade, and relationship to BRL-101 of SAEs following BRL-101 reinfusion.

Countries

China

Contacts

CONTACTRongmei Liang, phD
rongmeiliang@brlmed.com021-64340008
STUDY_CHAIRRongmei Liang, PhD

Bioray Laboratories

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 22, 2026