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

NCT05762510 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-05-09

No results posted yet for this study

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.

Conditions

  • Transfusion Dependent Beta-Thalassemia

Interventions

GENETIC

GMCN-508B (LentiRed)

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

Sponsors & Collaborators

  • Genmedicn Biopharma Ltd.

    collaborator UNKNOWN

  • First Affiliated Hospital of Guangxi Medical University

    lead OTHER

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
2023-02-22
Primary Completion
2028-04-01
Completion
2030-10-31

Countries

  • China

Study Locations

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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 NCT05762510 on ClinicalTrials.gov