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

NCT06298630 · tracked via the Priya Life Science China tracker

Sponsor

Bioray Laboratories

Phase

Observational

Started

2024-12-08

Last updated

2026-07-21

Condition(s) studied

Thalassemia, Beta

Investigational drug(s) / intervention(s)

Assessments

Assessments: Safety and efficacy assessments

Study summary

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

Eligibility

Sex

ALL

Min age

3 Years

Max age

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 exclusion criteria for this study

Primary outcome measure(s)

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.

Trial sites (7)

Facility	City	Region	Status
Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong	Active Not Recruiting
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Guangzhou	Guangdong	Not Yet Recruiting
Shenzhen Children 's Hospital	Shenzhen	Guangdong	Not Yet Recruiting
No. 923 Hospital of Joint Support Force of Chinese People 's Liberation Army Hospital	Nanning	Guangxi	Not Yet Recruiting
Xiangya Hospital of Central South University	Changsha	Hunan	Recruiting
Tianjin Institute of Hematology	Tianjin	Tianjin Municipality	Recruiting
The First Affiliated Hospital of GUANGXI MEDICAL UNIVERSITY	Guangxi	China	Recruiting

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Universal CAR-T Cells (BRL-301) in Relapse or Refractory Autoimmune Diseases Enrolling by invitation

Other trials for the same condition

Long-term Follow-up Study of BHC001 for TDT Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06298630 on ClinicalTrials.gov ↗ ← All trials in China