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. (STEADFAST long term)

Research summary

Transplant recipients will be invited to enrol in this LTFU study after they have completed the End-Of-Study (Week 84) visit or withdrawn from the Phase I/IIa study (TX200-KT02). Transplant recipients who were administered TX200-TR101 in the TX200-KT02 study will then proceed to have 13.5 years of follow-up post-enrolment to this study (equating approximately to 13.75 years of follow up post-end of ‘parent’ KT02 study). Since these subjects will have completed the first 1.5 years of follow-up post-dosing with TX200-TR101 in the TX200-KT02 study, this LTFU will enable the subjects to have a total of 15 years of follow-up post-dosing with TX200-TR101. Control transplant recipients will undergo the same duration of follow up, which will equate to approximately 13.75 years of follow-up post-end-of-study in KT02 (control transplant recipients were not administered TX200-TR101 in the TX200-KT02 study). Subjects will undergo a combination of study visits and phone calls/Home Health visits to gather information on their overall health.

Principal Investigator

Dr Paul Harden

Contact us

Email: renalandtransplanttrials@ouh.nhs.uk

IRAS number

1007749