Safety and Efficacy Evaluation of ET-01 Transplantation in Subjects With Transfusion Dependent -Thalassaemia

  • STATUS
    Recruiting
  • participants needed
    3
  • sponsor
    Institute of Hematology & Blood Diseases Hospital
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Updated on 5 August 2020
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Summary

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

Description

After proper subject is recruited, subject will go through steps generally as stem cell mobilization, apheresis, conditioning and ET-01 infusion to complete therapy. 2 years' follow up visits will be carried out post-transplantation and related data will be collected.

Details
Condition Transfusion Dependent Beta-Thalassaemia
Age 6years - 35years
Treatment ET-01
Clinical Study IdentifierNCT04390971
SponsorInstitute of Hematology & Blood Diseases Hospital
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Subject and/or subject's legal personal representative fully understand and voluntarily sign informed consent forms
~35 years old, all gender, weight 30kg
Genetically diagnosed -Thalassaemia
Diagnosed as transfusion-dependent
Eligible for autologous stem cell transplant
Organs in good function
Other protocol defined Inclusion criteria may apply

Exclusion Criteria

Thalassemia gene type is 0/0
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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