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

End Stage Renal Disease Clinical Trial

Official 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

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). ;

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic
• Kidney Transplant Rejection

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