Clinical trial Recruiting at 2 sites Observational Ages 5 to 35

Long-term observation of BHC001 treatment for beta thalassemia

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

Run by Bioray Laboratories · NCT06314529 · Data updated 2026-11-12

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.

More Beta-Thalassemia trials

Quick facts

Study typeObservational
Ages5 Years to 35 Years
SexAll
Enrollment6 (estimated)
SponsorBioray Laboratories
Industry-sponsored
Locations2 sites (Nanning, Guangxi and 1 other locations)
StatusRecruiting
StartedDecember 14, 2022
Main results expectedDecember 10, 2036
Study endsMay 10, 2037
Registry record updatedMarch 18, 2024
Trial IDNCT06314529 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are individuals with transfusion-dependent beta thalassemia who have previously been treated with BRL-101.

Probably not a fit

Patients who have not been treated with BRL-101 or those with other forms of thalassemia may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study observes the long-term safety and efficacy of BHC001 in patients with transfusion-dependent beta thalassemia (TDT). Participants who have been treated with BRL-101 will be monitored for delayed safety risks, including the emergence of neoplasms and hematological disorders. The study aims to gather comprehensive data on the long-term effects of the treatment following intravenous infusion. It is an observational study, meaning it will focus on collecting data without any experimental intervention.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of BHC001 for patients with beta thalassemia.

How similar studies have gone: While this study focuses on long-term effects, similar observational studies have shown success in monitoring treatment outcomes in chronic conditions, suggesting a potential for valuable findings.

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

  • The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army
    Nanning, Guangxi, China
    Recruiting
  • Xiangya Hospital of Central South University
    Changsha, Hunan, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.