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NCT Number: NCT05987527

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Kidney Transplant Rejection Chronic Disease Disease Attributes End Stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–72 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Leuven, Leuven, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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Subjects who enrolled in the Phase I/IIa study TX200-KT02, received a transplanted kidney and have either completed or withdrawn from that study.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

Treatment and study plan

Blood sample

Diagnostic Test

Routine procedures

Primary outcomes

  1. Safety and Tolerability of TX200-TR101 infusion evaluated by overall survival

    Time frame: Up to 15 years post infusion

    Long term safety and tolerability of TX200-TR101 infusion evaluated by overall survival

  2. Safety and Tolerability TX200-TR101 infusion evaluated by and incidence of serious adverse events (SAEs) according to CTCAE V5.0.

    Time frame: 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.

Secondary outcomes

  1. Long term graft related outcomes

    Time frame: Up to 15 years post infusion

    Incidence of graft rejection according to the Banff classification criteria

  2. Number of in-patient days in hospital to evaluate the effect of TX200-TR101 over a long term

    Time frame: Up to 15 years post infusion

    Number of in-patient days in hospital

  3. Incidence of Adverse Events related to TX200-TR101 over a long term period

    Time frame: Up to 15 years post infusion

    Incidence of Adverse Events related to TX200-TR101

  4. Incidence of Adverse Events of special interest as defined in the protocol over long term

    Time frame: Up to 15 years post infusion

    Incidence of Adverse Events of special interest as defined in the protocol

  5. Change in immunosuppression regime to evaluate long term safety of TX200-TR101

    Time frame: Up to 15 years post infusion

    Change in immunosuppression regime

  6. Incidence of graft loss due to rejection to evaluate the composite efficacy profile of TX200-TR101

    Time frame: Up to 15 years post infusion

    Incidence of graft loss due to rejection

  7. Incidents of deaths to evaluate composite efficacy profile of TX200-TR101

    Time frame: Up to 15 years post infusion

    Incidences of death of TX200-TR101 participants

  8. Incidence of chronic graft dysfunction measured by changes in estimated glomerular filtration rate to evaluate the composite efficacy profile of TX200-TR101

    Time frame: Up to 15 years post infusion

    Incidence of chronic graft dysfunction measured by changes in estimated glomerular filtration rate

Sponsors and collaborators

Lead sponsor

Sangamo Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2039
Study completion
2039
First posted
Aug 14, 2023
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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