STEADFAST Long Term
Research type
Research Study
Full title
Long-Term Follow-Up of Patients who have received an Autologous Antigen-Specific Chimeric Antigen Receptor T Regulatory Cell Therapy (CAR- Treg therapy, TX200-TR101) in a prior clinical study.
IRAS ID
1007749
Contact name
Eleonore Mathe
Contact email
Sponsor organisation
Sangamo Therapeutics France SAS
Eudract number
2022-002440-40
Research summary
This study is a Long-Term Follow Up Study that is being carried out to assess the safety and tolerability of TX200-TR101 in study participants who have been administered this TX200-TR101 Cell Therapy in a previous clinical trial. TX200-TR101 is an Autologous Antigen-Specific Chimeric Antigen Receptor T Regulatory Cell Therapy that is administered to patients who have undergone a kidney transplant. The aim of this therapeutic agent is to promote immune tolerance to renal transplantation, in order to replace long-term pharmacological immunosuppression.
Participants have been invited to enroll in this LTFU study after they have either completed or withdrawn from the parent clinical study. Transplant recipients who were administered TX200-TR101 in the parent study will have an additional 13.5 years of follow-up in the LTFU study. With 1.5 years of follow-up post-dosing with TX200-TR101 in the Parent Study, this LTFU will give a total of 15 years of observation post-treatment with TX200-TR101.
Within this clinical trial, study participants will be subject to visits every 6 months over the course of years 2 to 5 (3 years), followed by once a year between years 6 and 15 (9 years) post kidney transplant. These visits will vary in nature as some will be Study Visits while others will be Phone Calls/Home Health visits to gather information on their overall health.
By closely following the Long-Term Progress of each study participant’s kidney transplant, the Sponsor aim to understand which changes/effects are a result of the study medication and which effects are a result of the natural course of the transplant.
Sangamo Therapeutics France SAS are funding the research for this study and participants will be recruited from a number of different countries including Belgium, Netherlands, Germany and the United Kingdom.REC name
South Central - Oxford A Research Ethics Committee
REC reference
23/SC/0233
Date of REC Opinion
19 Sep 2023
REC opinion
Further Information Favourable Opinion