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RecruitingNCT06298630Updated Jul 21, 2026

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

An observational study in Thalassemia, Beta, sponsored by Bioray Laboratories. Recruiting at 7 sites in China. Open to participants aged 3 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by Bioray Laboratories · Observational

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 9 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
45
Ages
3 Years to 35 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Thalassemia, Beta

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03

In context

beta-Thalassemia

304 studies on the registry are indexed under beta-Thalassemia; 70 are open to participants now.

This study's planned enrollment of 45 is below the median of 100 across 81 observational studies indexed under beta-Thalassemia.

Browse beta-Thalassemia studies →

Lead sponsor

Bioray Laboratories is the lead sponsor of 24 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects with transfusion-dependent β-thalassemia who have been treated with BRL-101.

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

Exclusion Criteria:

- There are no exclusion criteria for this study

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
45 participants (estimated)
Patient registry
No

Groups and cohorts

  • BRL-101

    All patients who have received BRL-101

    Other: Assessments

Interventions

  • OtherAssessments

    Safety and efficacy assessments

06

What researchers measure

Primary outcomes

  1. Incidence of hematologic malignancies

    Such as new lymphoma, leukemia, MDS, etc.

    Time frame: Up to 15 years post-drug product infusion

  2. 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

07

Study locations

3 of 7 sites recruiting
  • Nanfang Hospital, Southern Medical University
    Guangzhou, Guangdong 510006, China
    Active, not recruiting
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    Guangzhou, Guangdong 510006, China
    • Jianpei Fang, phD · Contact
    Not yet recruiting
  • Shenzhen Children 's Hospital
    Shenzhen, Guangdong 510006, China
    • Sixi Liu, phD · Contact
    Not yet recruiting
  • No. 923 Hospital of Joint Support Force of Chinese People 's Liberation Army Hospital
    Nanning, Guangxi 530021, China
    • Xinhua Zhang, phD · Contact
    Not yet recruiting
  • Xiangya Hospital of Central South University
    Changsha, Hunan 510510, China
    • Bin Fu, PhD · Contact
    Recruiting
  • Tianjin Institute of Hematology
    Tianjin, Tianjin Municipality 300000, China
    • Jun shi, PhD · Contact
    Recruiting
  • The First Affiliated Hospital of GUANGXI MEDICAL UNIVERSITY
    Guangxi, 530021, China
    • Yongrong Lai, PhD · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06298630
Lead sponsor
Bioray Laboratories
Collaborators
First Affiliated Hospital of Guangxi Medical University, Xiangya Hospital of Central South University, Chinese Academy of Medical Sciences, Nanfang Hospital, Southern Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army, Shenzhen Children's Hospital
Responsible party
Sponsor
First posted
Mar 7, 2024
Start date
Dec 8, 2024
Primary completion
Aug 20, 2038 (estimated)
Completion
Oct 15, 2038 (estimated)
Last update
Jul 21, 2026

Study contacts

Rongmei Liang, phD
Contact
rongmeiliang@brlmed.com
021-64340008
Rongmei Liang, PhD
study chair · Bioray Laboratories

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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