Long-term safety and effectiveness of BRL-101 in transfusion-dependent beta-thalassemia
Official title: Long-term Follow-up Study of BRL-101 in the Treatment of Transfusion-dependent β-thalassemia
Run by Bioray Laboratories · NCT06298630 · Data updated 2026-11-12
This study looks at whether BRL-101 remains safe and effective over the long term for people with transfusion-dependent beta-thalassemia.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 3 Years to 35 Years |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | Bioray Laboratories Industry-sponsored |
| Locations | 7 sites (Guangzhou, Guangdong and 6 other locations) |
| Status | Recruiting |
| Started | December 8, 2024 |
| Main results expected | August 20, 2038 |
| Study ends | October 15, 2038 |
| Registry record updated | July 21, 2026 |
| Trial ID | NCT06298630 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals with transfusion-dependent beta-thalassemia who have previously received BRL-101 and can provide informed consent.
✕Probably not a fit
Patients who have not received BRL-101 or who do not wish to participate may not benefit from the study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational follow-up tracks patients who have already been treated with BRL-101 to monitor long-term safety, including risks like new cancers or blood disorders, and to see how well the treatment continues to work over time. The study collects ongoing assessments after intravenous BRL-101 infusions in adults and/or children with TDT. No intervention beyond standard care is performed, and data are gathered to understand long-term outcomes. The research is conducted at multiple Chinese medical centers with lead sponsorship by Bioray Laboratories.
Why it matters
Potential benefit: Participants may gain better understanding of long-term safety and durability of BRL-101 effects, informing future care decisions.
How similar studies have gone: Other long-term follow-up studies of similar biologic therapies in hematologic conditions have shown the value of monitoring delayed safety and sustained efficacy.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Xiangya Hospital of Central South University
Changsha, Hunan, China Recruiting -
Tianjin Institute of Hematology
Tianjin, Tianjin Municipality, China Recruiting -
The First Affiliated Hospital of GUANGXI MEDICAL UNIVERSITY
Guangxi, China Recruiting -
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China Active not recruiting -
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China Not yet recruiting -
Shenzhen Children 's Hospital
Shenzhen, Guangdong, China Not yet recruiting
Show 1 more location
-
No. 923 Hospital of Joint Support Force of Chinese People 's Liberation Army Hospital
Nanning, Guangxi, China Not yet recruiting
Study contacts
- Study coordinator: Rongmei Liang, phD
- Email: rongmeiliang@brlmed.com
- Phone: 021-64340008
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Long-term observation of BHC001 treatment for beta thalassemia
This study looks at the long-term safety and effects of a treatment called BHC001 in people with beta thalassemia who need regular blood transfusions.
-
Investigating genetic factors in blood disorders
This study is trying to find out how genes affect blood disorders like sickle cell disease and thalassemia by looking at the DNA of many people with these conditions.
-
Immune suppression treatment for sickle cell disease and beta-thalassemia patients receiving stem cell transplants
This study is testing if a new immune suppression treatment can help people with sickle cell disease or beta-thalassemia have better outcomes when they receive stem cell transplants.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.