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.
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 Type
OBSERVATIONAL
Enrollment
11
Routine procedures
University Hospitals Leuven
Leuven, Belgium
University Medical Center Groningen
Groningen, Netherlands
Leiden University Medical Centre
Leiden, Netherlands
Erasmus MC, University Medical Center
Rotterdam, Netherlands
Safety and Tolerability of TX200-TR101 infusion evaluated by overall survival
Long term safety and tolerability of TX200-TR101 infusion evaluated by overall survival
Time frame: Up to 15 years post infusion
Safety and Tolerability TX200-TR101 infusion evaluated by and incidence of serious adverse events (SAEs) according to CTCAE V5.0.
Long term safety and tolerability of 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 graft related outcomes
Incidence of graft rejection according to the Banff classification criteria
Time frame: Up to 15 years post infusion
Number of in-patient days in hospital to evaluate the effect of TX200-TR101 over a long term
Number of in-patient days in hospital
Time frame: Up to 15 years post infusion
Incidence of Adverse Events related to TX200-TR101 over a long term period
Incidence of Adverse Events related to TX200-TR101
Time frame: Up to 15 years post infusion
Incidence of Adverse Events of special interest as defined in the protocol over long term
Incidence of Adverse Events of special interest as defined in the protocol
Time frame: Up to 15 years post infusion
Change in immunosuppression regime to evaluate long term safety of TX200-TR101
Change in immunosuppression regime
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Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
Time frame: Up to 15 years post infusion
Incidence of graft loss due to rejection to evaluate the composite efficacy profile of TX200-TR101
Incidence of graft loss due to rejection
Time frame: Up to 15 years post infusion
Incidents of deaths to evaluate composite efficacy profile of TX200-TR101
Incidences of death of TX200-TR101 participants
Time frame: Up to 15 years post infusion
Incidence of chronic graft dysfunction measured by changes in estimated glomerular filtration rate to evaluate the composite efficacy profile of TX200-TR101
Incidence of chronic graft dysfunction measured by changes in estimated glomerular filtration rate
Time frame: Up to 15 years post infusion