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
Updated on 19 February 2024

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 on19 February 2024

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

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.

Learn more

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

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study AnnotationsStudy Notes

Notes added here are public and can be viewed by anyone. Notes added here are only available to you and those who you share with.

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.