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

View Details

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