A phase 1/2a study of TX200-TR101 in renal transplant recipients
Research type
Research Study
Full title
A Multicentre, Open-Label, Single Ascending Dose, Dose Ranging, Phase I/IIa Study to Evaluate the Safety and Tolerability of an Autologous Antigen-Specific Chimeric Antigen Receptor T Regulatory Cell Therapy (TX200-TR101) in Living Donor Renal Transplant Recipients
IRAS ID
265383
Contact name
Paul Harden
Contact email
Sponsor organisation
Sangamo Therapeutics France SAS
Eudract number
2019-001730-34
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Chronic kidney disease (CKD) is a long-term condition where the kidneys (two organs that filter blood) no longer work as well as they should. It is possible to replicate some of the kidney function with dialysis (where a machine filters the blood) but as the disease worsens, known as end-stage renal disease (ESRD), a kidney transplant remains the treatment of choice. Following a kidney transplant, recipients receive immunosuppressants (drugs which dampen-down the immune system) to allow the body to accept the transplanted kidney as one of its own. These drugs can cause serious side effects and currently need to be taken life-long.
This clinical study is to investigate the safety and side effects of the investigational product TX200-TR101 in humans. TX200-TR101 has not yet been approved by regulatory agencies or any other health authorities for sale, but it has been approved for use in this clinical study. This is the first time that TX200-TR101 will be given to humans.
TX200-TR101 is an investigational gene-modified cell product that is made from the recipient’s own cells that have been genetically modified. It is hoped that TX200-TR101 will help reduce the risk of organ rejection by helping the body to accept the transplanted kidney and in time reduce the need for immunosuppressants.
Participants will have some of their cells collected (via a procedure called leukapheresis) and subsequently modified to become TX200-TR101. These will then be given back to the participant 3 months after their transplant. Participants will continue to take their immunosuppressive medication even after the TX200-TR101 infusion.
Some participants will not receive TX200-TR101 and will act as a comparison.
Sangamo Therapeutics France SAS (the Sponsor) is responsible for the development and oversight of the study. Around 21 participants will take part at approximately 5 medical centres across Europe, including the UK.REC name
South Central - Oxford A Research Ethics Committee
REC reference
19/SC/0531
Date of REC Opinion
24 Mar 2020
REC opinion
Favourable Opinion