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

Sangamo Therapeutics

Status: Invitation-only

Conditions: End Stage Renal Disease; Kidney Transplant Rejection

Treatments: Diagnostic Test: Blood sample

Study type: Observational

Funder types: Industry

Identifiers

NCT05987527

TX200-KT03

2022-002440-40 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 estimated patients

Sex: All

Ages: 18 to 72 years old

Volunteers: No Healthy Volunteers

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Subjects who enrolled in the Phase I/IIa study TX200-KT02, received a transplanted kidney and have either completed or withdrawn from that study.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

Trial design

11 participants in 2 patient groups

Treatment group

Description:

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

Treatment:

Diagnostic Test: Blood sample

Control group

Description:

Subjects underwent a kidney transplant as per planned standard of care in study TX200-KT02 with no study drug administered

Treatment:

Diagnostic Test: Blood sample