End Stage Renal Disease, Kidney Transplant Rejection
Conditions
Keywords
Regulatory T-Cells, Genetically modified cells, Chimeric antigen receptor, Long term follow up, T-Regs, Cell Therapy
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.
Interventions
DIAGNOSTIC_TESTBlood sample
Routine procedures
Sponsors
Sangamo Therapeutics
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 72 Years
Healthy volunteers
No
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Subjects who enrolled in the Phase I/IIa study TX200-KT02, received a transplanted kidney and have either completed or withdrawn from that study. 2.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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Change in immunosuppression regime to evaluate long term safety of TX200-TR101 | Up to 15 years post infusion | Change in immunosuppression regime |
| Long term graft related outcomes | Up to 15 years post infusion | Incidence of graft rejection according to the Banff classification criteria |
| 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 |
| 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 |
Countries
Belgium, Netherlands, United Kingdom
Outcome results
None listed