MedTrace Logo

Safety and Efficacy Evaluation of γ-globin Reactivated Autologous Hematopoietic Stem Cells

NCT05442346 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-02-28

No results posted yet for this study

Summary

This is a single arm, open label, single-dose, phase 1/2 study in up to 5 participants with β-thalassemia major.The study will evaluate the safety and efficacy of the treatment with γ-globin reactivated autologous hematopoietic stem cells in subjects with β-thalassemia major.

Conditions

  • Thalassemia Major

Interventions

BIOLOGICAL

γ-globin reactivated autologous hematopoietic stem cells

gene edited autologous hematopoietic stem cells with γ-globin expression; BRL-103

Sponsors & Collaborators

  • First Affiliated Hospital of Guangxi Medical University

    collaborator OTHER

  • Bioray Laboratories

    lead INDUSTRY

Principal Investigators

  • lai yongrong, PhD · First Affiliated Hospital of Guangxi Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-25
Primary Completion
2024-09-08
Completion
2024-11-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05442346 on ClinicalTrials.gov