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Clinical Trials in China / NCT06314529
Recruiting Observational

Long-term Follow-up Study of BHC001 for TDT

NCT06314529 · tracked via the Priya Life Science China tracker
Sponsor
Bioray Laboratories
Phase
Observational
Started
2022-12-14
Last updated
2024-03-18

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 BHC001 in TDT subjects.

Eligibility

Sex
ALL
Min age
5 Years
Max age
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 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 (2)

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

More Bioray Laboratories trials in China

Universal CAR-T Cells (BRL-301) in Relapse or Refractory Autoimmune Diseases Enrolling by invitation
Universal CAR-T Cell Therapy for MM Recruiting
Safety and Efficacy Evaluation of BRL-101 in Subjects With Transfusion-Dependent β-Thalassemia Active, not recruiting
Long-term Follow-up Study of BRL-101 for TDT Recruiting
The Safety and Efficacy of BRL-201 in the Treatment of r/r B Lymphocyte Non-Hodgkin Lymphoma Recruiting

Other trials for the same condition

Long-term Follow-up Study of BRL-101 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 NCT06314529 on ClinicalTrials.gov ↗ ← All trials in China