RecruitingEarly Phase 1NCT05762510

A Study Evaluating the Safety and Efficacy of LentiRed Drug Product in Transfusion-dependent β-Thalassemia [TDT]

An Open Label Study Evaluating the Safety and Efficacy of Gene Therapy for Transfusion-dependent β-Thalassemia by Transplantation of Autologous CD34+ Stem Cells Transduced Ex Vivo With a LentiRed Lentiviral Vector (GMCN-508B Drug Product, Also Called LentiRed)


Sponsor

First Affiliated Hospital of Guangxi Medical University

Enrollment

5 participants

Start Date

Feb 22, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-arm, open label, single-dose study in subjects with transfusion dependent β-thalassaemia. The study will evaluate the safety and efficacy of autologous CD34+ Human Hematopoietic Stem Cells that was transduced with LentiRed Lentivrial vector.


Eligibility

Min Age: 5 YearsMax Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying GMCN-508B (LentiRed) for people with transfusion dependent beta-thalassemia. The study is currently recruiting participants at 1 location. People eligible for this study include aged 5 Years to 35 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

GENETICGMCN-508B (LentiRed)

LentiRed Drug Product is administered by intravenous infusion following myeloablative conditioning with busulfan.


Locations(1)

The affiliated hospital of guangxi medical university

Nanning, Guangxi, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05762510


Related Trials