Safety & Tolerability Study of Chimeric Antigen Receptor T-Reg Cell Therapy in Living Donor Renal Transplant Recipients

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

March 17, 2021

Primary Completion Date

July 11, 2024

Study Completion Date

October 29, 2025

Conditions
Kidney Transplant RejectionEnd Stage Renal Disease
Interventions
BIOLOGICAL

TX200-TR101

TX200-TR101 is an autologous gene therapy medicinal product composed of Treg cells (CD4+/CD45RA+/CD25+/CD127low/neg) that have been ex vivo expanded and transduced with a lentiviral vector encoding for a CAR to recognize HLA-A\*02. Treatment will be given via an IV infusion at a pre-defined timepoint several weeks after transplant. Four, single ascending dose cohorts of TX200-TR101 are planned and an additional expansion cohort.

Trial Locations (5)

Unknown

University Hospitals Leuven, Leuven

University Medical Center Groningen, Groningen

Oxford University Hospitals NHS Foundation Trust,, Oxford

2333 ZA

Leiden University Medical Centre, Leiden

3015 CN

Erasmus MC, University Medical Center, Rotterdam

Sponsors
All Listed Sponsors
lead

Sangamo Therapeutics

INDUSTRY