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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sangamo Therapeutics Inc.
- Enrollment
- 20
- Locations
- 4
- Primary Endpoint
- Overall survival
- Status
- Active, not recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
To evaluate the long-term safety and tolerability of TX200-TR101 up to 15 years post-TX200-TR101 infusion/baseline.
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.
Investigators
Sangomo Patient Advocacy
Scientific
Sangamo Therapeutics Inc.
Eligibility Criteria
Inclusion Criteria
- •Subjects who enrolled in the Phase I/IIa study TX200-KT02, received a transplanted kidney and have either completed or withdrawn from that study.
- •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
- •No Exclusion criteria for this study
Outcomes
Primary Outcomes
Overall survival
Overall survival
Indicence and grade of Serious Adverse Events
Indicence and grade of Serious Adverse Events
Secondary Outcomes
- Incidence of graft loss due to rejection
- Incidence and severity of chronic graft dysfunction, as measured by eGFR
- Incidence of immune-mediated rejection in terms of BCAR episodes according to the Banff criteria (including type, severity and timing)