NCT05577312

A Phase 1/2 Clinical Study to Evaluate the Safety and Efficacy of Single Dose Intravenous Infusion of BRL-101 in Subjects With Transfusion-Dependent β-Thalassemia

Study Summary

This is a non-randomized, open label, multi-site, single-dose, phase 1/2 study in subjects with Transfusion-Dependent β-Thalassemia (TDT). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells (hHSPCs) (BRL-101)

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Interventions

BRL-101DRUG
CD34 + autologous hematopoietic stem and progenitor cells edited at the BCL11A enhancer site

Study Locations

FacilityCityStateCountry
Nanfang Hospital, Southern Medical UniversityGuangzhouGuangdongChina
The First Affiliated Hospital of Guangxi Medical UniversityNanningGuangxiChina
Xiangya Hospital of Central South UniversityChangshaHunanChina
Chinese Academy of Medical SciencesTianjinTianjin MunicipalityChina

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026