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

Phase 3

Recruiting

• Conditions: Kidney Transplant Rejection

• Registration Number: 2024-512580-31-00
• Lead Sponsor: Sangamo Therapeutics Inc.

Brief Summary

To evaluate the long-term safety and tolerability of TX200-TR101 up to 15 years post-TX200-TR101 infusion/baseline.

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.

Study Timeline

• Study First Posted: 2024-07-31
• Last Update Posted: 2025-06-06

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1. Subjects who enrolled in the Phase I/IIa study TX200-KT02, received a transplanted kidney and have either completed or withdrawn from that study.

2. Willing and able to provide written informed consent (IC) in accordance with local regulations and governing Independent Ethics Committee (IEC)/Institutional Review Board (IRB) requirements prior to any procedure or evaluation performed specifically for the sole purpose of the study.

Exclusion Criteria

No Exclusion criteria for this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival		Overall survival
Indicence and grade of Serious Adverse Events		Indicence and grade of Serious Adverse Events

Secondary Outcome Measures

Name	Time	Method
Incidence of graft loss due to rejection		Incidence of graft loss due to rejection
Incidence and severity of chronic graft dysfunction, as measured by eGFR		Incidence and severity of chronic graft dysfunction, as measured by eGFR
Incidence of immune-mediated rejection in terms of BCAR episodes according to the Banff criteria (including type, severity and timing)		Incidence of immune-mediated rejection in terms of BCAR episodes according to the Banff criteria (including type, severity and timing)

Trial Locations

Locations (4)

UZ Leuven; 🇧🇪 Leuven, Belgium

Universiteit Leiden; 🇳🇱 Leiden, Netherlands

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC); 🇳🇱 Rotterdam, Netherlands

Universitair Medisch Centrum Groningen; 🇳🇱 Groningen, Netherlands

UZ Leuven

🇧🇪Leuven, Belgium

Dirk Kuypers

Site contact

016344580

dirk.kuypers@uzleuven.be