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

• Conditions: Kidney Transplant Rejection; End Stage Renal Disease
• Interventions: Diagnostic Test: Urine sample; Diagnostic Test: Blood sample; Other: Lifestyle questionnaire

• Registration Number: NCT05987527
• Lead Sponsor: Sangamo Therapeutics

Brief 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.

Study Timeline

• Study First Submitted: 2023-06-30
• Study First Submitted QC: 2023-08-03
• Study First Posted: 2023-08-14
• Study Start: 2023-08-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-14
• Primary Completion: 2039-06-11
• Study Completion: 2039-06-11

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 11

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Subjects who enrolled in the Phase I/IIa study TX200-KT02, received a transplanted kidney and have either completed or withdrawn from that study.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

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Urine sample	Subjects underwent a kidney transplant as per planned standard of care in study TX200-KT02 with no study drug administered, up to 6 subjects
Treatment group	Urine sample	Subjects underwent a kidney transplant as per planned standard of care and were administered study drug TX200-TR101 in study TX200-KT02 post transplantation Assigned interventions - subjects who received TX200-TR101 in clinical study TX200-KT02
Treatment group	Blood sample	Subjects underwent a kidney transplant as per planned standard of care and were administered study drug TX200-TR101 in study TX200-KT02 post transplantation Assigned interventions - subjects who received TX200-TR101 in clinical study TX200-KT02
Treatment group	Lifestyle questionnaire	Subjects underwent a kidney transplant as per planned standard of care and were administered study drug TX200-TR101 in study TX200-KT02 post transplantation Assigned interventions - subjects who received TX200-TR101 in clinical study TX200-KT02
Control group	Blood sample	Subjects underwent a kidney transplant as per planned standard of care in study TX200-KT02 with no study drug administered, up to 6 subjects
Control group	Lifestyle questionnaire	Subjects underwent a kidney transplant as per planned standard of care in study TX200-KT02 with no study drug administered, up to 6 subjects

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability TX200-TR101 infusion evaluated by and incidence of serious adverse events (SAEs) according to CTCAE V5.0.	Up to 15 years post infusion	Long term safety and tolerability of TX200-TR101 infusion evaluated by and incidence of serious adverse events (SAEs) according to CTCAE V5.0.
Safety and Tolerability of TX200-TR101 infusion evaluated by overall survival	Up to 15 years post infusion	Long term safety and tolerability of TX200-TR101 infusion evaluated by overall survival

Secondary Outcome Measures

Name	Time	Method
Incidents of deaths to evaluate composite efficacy profile of TX200-TR101	Up to 15 years post infusion	Incidences of death of TX200-TR101 participants
Incidence of chronic graft dysfunction measured by changes in estimated glomerular filtration rate to evaluate the composite efficacy profile of TX200-TR101	Up to 15 years post infusion	Incidence of chronic graft dysfunction measured by changes in estimated glomerular filtration rate
Incidence of graft loss due to rejection to evaluate the composite efficacy profile of TX200-TR101	Up to 15 years post infusion	Incidence of graft loss due to rejection
Long term graft related outcomes	Up to 15 years post infusion	Incidence of graft rejection according to the Banff classification criteria
Number of in-patient days in hospital to evaluate the effect of TX200-TR101 over a long term	Up to 15 years post infusion	Number of in-patient days in hospital
Change in immunosuppression regime to evaluate long term safety of TX200-TR101	Up to 15 years post infusion	Change in immunosuppression regime
Incidence of Adverse Events related to TX200-TR101 over a long term period	Up to 15 years post infusion	Incidence of Adverse Events related to TX200-TR101
Incidence of Adverse Events of special interest as defined in the protocol over long term	Up to 15 years post infusion	Incidence of Adverse Events of special interest as defined in the protocol

Trial Locations

Locations (5)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium

Oxford University Hospitals NHS Foundation Trust; 🇬🇧 Oxford, United Kingdom

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Leiden University Medical Centre; 🇳🇱 Leiden, Netherlands

Erasmus MC, University Medical Center; 🇳🇱 Rotterdam, Netherlands