NCT05987527

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

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: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 11 (estimated)
• Sponsor: Sangamo Therapeutics · Industry
• Sex: All
• Age: 18 Years – 72 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Kidney Transplant Rejection
• End Stage Renal Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood sample	Routine procedures

Timeline

• Start date: 2023-08-15
• Primary completion: 2039-06-11
• Completion: 2039-06-11
• First posted: 2023-08-14
• Last updated: 2025-12-04

Locations

5 sites across 3 countries: Belgium, Netherlands, United Kingdom