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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-002440-40 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | 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 | Subjects underwent a kidney transplant as per planned standard of care in study TX200-KT02 with no study drug administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample | Diagnostic Test | Routine procedures |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of TX200-TR101 infusion evaluated by overall survival | Long term safety and tolerability of TX200-TR101 infusion evaluated by overall survival | 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. | Up to 15 years post infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Long term graft related outcomes | Incidence of graft rejection according to the Banff classification criteria | Up to 15 years post infusion |
| Number of in-patient days in hospital to evaluate the effect of TX200-TR101 over a long term |
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Inclusion Criteria:
Exclusion Criteria:
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Transplant recipients enrolled in the Phase I/IIa study (TX200-KT02) and who have consented to participate in this LTFU study,
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Leuven | Belgium | ||||
| University Medical Center Groningen |
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| Label | URL |
|---|---|
| Link to parent study STEADFAST, TX200-KT02 | View source |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Whole blood
Number of in-patient days in hospital
| 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 | 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 | Up to 15 years post infusion |
| Change in immunosuppression regime to evaluate long term safety of TX200-TR101 | Change in immunosuppression regime | 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 | Up to 15 years post infusion |
| Incidents of deaths to evaluate composite efficacy profile of TX200-TR101 | Incidences of death of TX200-TR101 participants | 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 | Up to 15 years post infusion |
| Groningen |
| Netherlands |
| Leiden University Medical Centre | Leiden | Netherlands |
| Erasmus MC, University Medical Center | Rotterdam | Netherlands |
| Oxford University Hospitals NHS Foundation Trust | Oxford | United Kingdom |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |