MedTrace Logo

A Study Evaluating the Safety and Efficacy of the BD211 Drug Product in β-Thalassemia Major Participants

NCT05015920 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-05-18

No results posted yet for this study

Summary

This is a Phase 1,open label,safety,and efficacy study in subjects with non-β0/β0 TDT β-thalassemia Major by transplanting BD211 drug product which is for autologous use only,via a single IV administration.

Conditions

Interventions

GENETIC

BD211 Drug Product

Transplantation of Autologous CD34+Stem Cells Transduced to BD211 finished Product with a Lentiviral Vector coding βA-T87Q-Globin.

Sponsors & Collaborators

  • 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

    collaborator OTHER

  • Shanghai BDgene Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Sanbin Wang, Dr. · 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-07-10
Primary Completion
2024-08-23
Completion
2024-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05015920 on ClinicalTrials.gov