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

End Stage Renal Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05987527
• Other study ID #: TX200-KT03
• Secondary ID: 2022-002440-40
• Status: Enrolling by invitation
• Start date: August 15, 2023
• Est. completion date: September 4, 2039

Study information

• Verified date: April 2024
• Source: Sangamo Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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. In addition, the long-term effects and durability of the clinical effect of TX200-TR101 in subjects who received TX200-TR101 will be assessed and compared with control participants in the interventional Study (TX200- KT02).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 21
• Est. completion date: September 4, 2039
• Est. primary completion date: September 4, 2039
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 72 Years

Eligibility

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Subjects who enrolled in the Phase I/IIa study TX200-KT02, received a transplanted kidney and have either completed or withdrawn from that study.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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic
• Kidney Transplant Rejection

Intervention

Diagnostic Test:
• Urine sample
Routine procedures
• Blood sample
Routine procedures

Other:
• Lifestyle questionnaire
Lifestyle questionnaire

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Leiden University Medical Centre	Leiden
Netherlands	Erasmus MC, University Medical Center	Rotterdam
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Sangamo Therapeutics

Countries where clinical trial is conducted

Belgium,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Long term graft related outcomes	Incidence of graft rejection according to the Banff classification criteria	Up to 15 years post infusion
Secondary	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	Up to 15 years post infusion
Secondary	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
Secondary	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
Secondary	Incidence of anti-drug antibodies against HLA A2 CAR Tregs to evaluate the effect of TX200-TR101 over a long term	Incidence of anti-drug antibodies against HLA A2 CAR Tregs	Up to 15 years post infusion
Secondary	Change in immunosuppression regime to evaluate long term safety of TX200-TR101	Change in immunosuppression regime	Up to 15 years post infusion
Secondary	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
Secondary	Incidents of deaths to evaluate composite efficacy profile of TX200-TR101	Incidences of death of TX200-TR101 participants	Up to 15 years post infusion
Secondary	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
Secondary	Impact on Quality of Life	SF-36 Questionnaire scaled with lower score meaning more disability scored ranging from 0-100 with 100 representing the highest health related quality of life	Up to 15 years post infusion

External Links

•   Link to parent study STEADFAST, TX200-KT02