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Clinical Study of BRL-101 in Severe SCD - Trial NCT06300723

Access comprehensive clinical trial information for NCT06300723 through Pure Global AI's free database. This phase not specified trial is sponsored by Bioray Laboratories and is currently Not yet recruiting. The study focuses on Sickle Cell Disease. Target enrollment is 1 participants.

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NCT06300723
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Trial Details
ClinicalTrials.gov โ€ข NCT06300723
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Clinical Study of BRL-101 in Severe SCD
Clinical Study to Evaluate the Safety and Efficacy of Single Dose Intravenous Infusion of CRISPR/Cas9-edited Autologous CD34 + Hematopoietic Stem/Progenitor Cells (BRL-101) in the Treatment of Severe Sickle Cell Disease

Study Focus

Sickle Cell Disease

BRL-101

Interventional

drug

Sponsor & Location

Bioray Laboratories

Nanning, China

Timeline & Enrollment

N/A

Apr 25, 2024

Jun 15, 2026

1 participants

Primary Outcome

Proportion of stem cell engrafted subjects,Time to neutrophil engraftment,Frequency, severity, and relationship to BRL-101 of adverse events over 12 months following BRL-101 infusion

Summary

This is a single center, non-randomized, open label, single-dose study in subjects with
 Sickle Cell Disease (SCD). The study will evaluate the safety and efficacy of autologous
 CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells (hHSPCs) (BRL-101).

ICD-10 Classifications

Sickle-cell disorders
Other sickle-cell disorders
Sickle-cell trait
Sickle-cell anaemia with crisis
Sickle-cell anaemia without crisis

Data Source

ClinicalTrials.gov

NCT06300723

Non-Device Trial