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Recruiting NCT05752123

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.

Conditions: Transfusion Dependent Beta-Thalassaemia

Sex: All
Ages: 6 Years – 35 Years
Phase: NA
Enrollment: 3
Sponsor: EdiGene (GuangZhou) Inc.

Location: China

Summary

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.

Eligibility Criteria

Key Inclusion Criteria: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.Key Exclusion Criteria:Subjects with associated α-thalassemia;Active bacterial, virus, fungal or parasitic infection, including HIV infection, HbsAg and HBV DNA positive, HCV DNA positive, or Treponema Pallidum infection;HLA identical sibling or unrelated donors are available;Prior allo-HSCT or gene therapy.Other protocol defined Exclusion criteria may apply.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05752123). StuddyBuddy aggregates publicly available trial information.