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NCT05752123Terminated

A Study to Evaluate the Safety and Efficacy of ET-01 Transplantation in Subjects with Transfusion Dependent Β-Thalassaemia.

A Single Site, Open Label Study to Evaluate the Safety and Efficacy of ET-01 Transplantation in Subjects with Transfusion Dependent Β-Thalassemia

Source: ClinicalTrials.gov · Last updated 30 Mar 2025

Brief summary (registry, in English)

This is an open label, single site study to evaluate the safety and Efficacy of ET-01 Transplantation in subjects with Transfusion Dependent β-Thalassaemia.

Status (registry)
Terminated
Study type
Interventional
Enrollment
2 (actual)
First submitted
16 Feb 2023
Start date
18 Feb 2023
Primary completion date
29 Jan 2024
Lead sponsor
EdiGene (GuangZhou) Inc.
Diseases
Thalassaemia
NCT number
NCT05752123

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior allo-HSCT or gene therapy.
    • Other protocol defined Exclusion criteria may apply.

Other illness

  • Active bacterial, virus, fungal or parasitic infection, including HIV infection, HbsAg and HBV DNA positive, HCV DNA positive, or Treponema Pallidum infection;

Other

  • Subjects with associated α-thalassemia;
  • HLA identical sibling or unrelated donors are available;

Who the study is looking for

  • Subject and/or subject's legal personal representative fully understand and voluntarily sign informed consent forms;
  • 6~35 years old, all gender;
  • Diagnosis of transfusion dependent β-thalassemia (β-TDT) as defined by protocol;
  • Eligible for autologous stem cell transplant;
  • Organs in good function.
    • Other protocol defined Inclusion criteria may apply.

Age in the registry: 6 years to 35 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
PLA 923 Hospital
Coordinator of this site? Confirm its status
NanningChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.