Status:
UNKNOWN
Safety and Efficacy Evaluation of ET-01 Transplantation in Subjects With Transfusion Dependent β-Thalassaemia
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Collaborating Sponsors:
EdiGene Inc.
The Affiliated Hospital Of Guizhou Medical University
Conditions:
Transfusion Dependent Beta-Thalassaemia
Eligibility:
All Genders
6-35 years
Phase:
NA
Brief Summary
This is an open label, multi-center study to evaluate the safety and Efficacy of ET-01 Transplantation in subjects with Transfusion Dependent β-Thalassaemia.
Detailed Description
After the proper subject is recruited, subject will go through steps generally as stem cell mobilization, apheresis, conditioning and ET-01 infusion to complete therapy. Two years follow-up will be ca...
Eligibility Criteria
Inclusion
- 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;
- Eligible for autologous stem cell transplant;
- Organs in good function.
- Other protocol defined inclusion criteria may apply.
Exclusion
- 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.
Key Trial Info
Start Date :
February 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2025
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04390971
Start Date
February 10 2023
End Date
August 15 2025
Last Update
November 27 2023
Active Locations (3)
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1
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550004
2
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China, 563000
3
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 300020