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Clinical Study of BRL-101 in the Treatment of Sickle Cell Disease - Trial NCT06287099

Access comprehensive clinical trial information for NCT06287099 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 5 participants.

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NCT06287099
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Trial Details
ClinicalTrials.gov โ€ข NCT06287099
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Clinical Study of BRL-101 in the Treatment of Sickle Cell Disease
Clinical Study on the Safety and Efficacy of a Single Intravenous Dose of CRISPR/Cas9-Edited Autologous CD34+ Hematopoietic Stem/Progenitor Cells (BRL-101) in the Treatment of Sickle Cell Disease

Study Focus

Sickle Cell Disease

BRL-101

Interventional

drug

Sponsor & Location

Bioray Laboratories

Timeline & Enrollment

N/A

Apr 20, 2024

May 10, 2026

5 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

NCT06287099

Non-Device Trial