Clinical trial NCT05987527: Long-Term Follow-Up of TX200-TR101 (STEADFAST Long Term)
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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Kidney Transplant Rejection
End Stage Renal Disease
Keywords: Regulatory T-Cells
Genetically modified cells
Chimeric antigen receptor
Long term follow up
T-Regs
Cell Therapy
Lead sponsor: Sangamo Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Transplant recipients enrolled in the Phase I/IIa study (TX200-KT02) and who have consented to participate in this LTFU study,

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.

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Subjects who enrolled in the Phase I/IIa study TX200-KT02, received a transplanted kidney and have either completed or withdrawn from that study.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

Primary outcomes:
measure: Safety and Tolerability of TX200-TR101 infusion evaluated by overall survival
timeFrame: Up to 15 years post infusion
measure: Safety and Tolerability TX200-TR101 infusion evaluated by and incidence of serious adverse events (SAEs) according to CTCAE V5.0.
timeFrame: Up to 15 years post infusion
Secondary outcomes:
measure: Long term graft related outcomes
timeFrame: Up to 15 years post infusion
measure: Number of in-patient days in hospital to evaluate the effect of TX200-TR101 over a long term
timeFrame: Up to 15 years post infusion
measure: Incidence of Adverse Events related to TX200-TR101 over a long term period
timeFrame: Up to 15 years post infusion
measure: Incidence of Adverse Events of special interest as defined in the protocol over long term
timeFrame: Up to 15 years post infusion
measure: Change in immunosuppression regime to evaluate long term safety of TX200-TR101
timeFrame: Up to 15 years post infusion
measure: Incidence of graft loss due to rejection to evaluate the composite efficacy profile of TX200-TR101
timeFrame: Up to 15 years post infusion
measure: Incidents of deaths to evaluate composite efficacy profile of TX200-TR101
timeFrame: Up to 15 years post infusion
measure: Incidence of chronic graft dysfunction measured by changes in estimated glomerular filtration rate to evaluate the composite efficacy profile of TX200-TR101
timeFrame: Up to 15 years post infusion
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Leiden
country: Netherlands
facility: Leiden University Medical Centre
city: Rotterdam
country: Netherlands
facility: Erasmus MC, University Medical Center
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
Study officials:
References: