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

Phase 1

Recruiting

Conditions: Kidney Transplant Rejection
MedDRA version: 21.1Level: LLTClassification code: 10050436Term: Prophylaxis against renal transplant rejection Class: 10042613
Therapeutic area: Phenomena and Processes [G] - Immune system processes [G12]

Registration Number: CTIS2024-512580-31-00

Lead Sponsor: Sangamo Therapeutics France

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 30

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Subjects who enrolled in the Phase I/IIa study TX200-KT02, received a transplanted kidney and have either completed or withdrawn from that study., 1. 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

1. Subjects/ persons committed to an institution following an administrative or judicial order.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Safety and Tolerability TX200-TR101 infusion evaluated by and incidence of serious adverse events (SAEs) according to CTCAE V5.0.;Secondary Objective: Long term graft related outcomes;Primary end point(s): Long term safety and tolerability of TX200-TR101 infusion evaluated by overall survival, Long term safety and tolerability of TX200-TR101 infusion evaluated by and incidence of serious adverse events (SAEs) according to CTCAE V5.0.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Incidence of graft rejection according to the Banff classification criteria;Secondary end point(s):Incidence of anti-drug antibodies against HLA A2 CAR Tregs;Secondary end point(s):Incidence of graft loss due to rejection;Secondary end point(s):Incidence of chronic graft dysfunction measured by changes in estimated glomerular filtration rate