Long-Term Follow-Up of TX200-TR101 (STEADFAST Long Term)

Status Enrolling by invitation

Clinical Trial Summary

This long-term follow-up study is being conducted to collect long-term (up to 15 years post-infusion) safety and tolerability data from subjects enrolled in studies evaluating TX200-TR101.

Clinical Trial Description

This is long- term follow up observational trial for patients who participated previously to a multicentre, first-in-human, open-label, single ascending dose, dose-ranging study of autologous, chimeric antigen receptor T regulatory cells (CAR-Treg) in HLA-A2 mismatched living donor kidney transplant recipients, with a control cohort of mismatched kidney transplant recipients of similar immunological risk. The aim is for this observational long-term follow up study (TX200-KT03) is to collect long-term (up to 15 years post-infusion) safety and tolerability data from subjects enrolled in studies evaluating TX200-TR101. In addition, the long-term effects and durability of the clinical effect of TX200-TR101 in subjects who received TX200-TR101 will be assessed and compared with control participants in the interventional Study (TX200- KT02). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05987527
Study type	Observational
Source	Sangamo Therapeutics
Contact
Status	Enrolling by invitation
Phase
Start date	August 15, 2023
Completion date	September 4, 2039

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