The purpose of this study is to evaluate the safety and tolerability of QEL-001 in the prevention of liver transplant rejection following immunosuppression withdrawal. QEL-001 is a product made from a patients own cells, which are genetically modified and designed to help the transplant recipient's body accept their donated liver and prevent their immune system from rejecting it once immune suppression is withdrawn.
This study is a multicenter, first-in-human, open-label, single-arm study of an autologous CAR T regulatory (CAR-Treg) in HLA-A2 mismatched liver transplant recipients. The aim is for the CAR-Tregs to be activated on recognition of HLA-A2 antigens present on the donated liver and subsequently induce and maintain immunological tolerance to the organ.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
QEL-001 is an autologous therapy that is composed of engineered regulatory T cells transduced with a lentiviral vector containing a CAR directed against HLA-A2. Treatment will be given via an IV infusion.
H. Saint Luc
Brussels, Belgium
RECRUITINGHopital Erasme
Brussels, Belgium
RECRUITINGUZ Leuven
Leuven, Belgium
RECRUITINGH. Clinic Barcelona
Barcelona, Spain
RECRUITINGHospital Reina Sofia
Córdoba, Spain
RECRUITINGG. Gergorio Maranon
Madrid, Spain
RECRUITINGQueen Elizabeth Hospital
Birmingham, United Kingdom
RECRUITINGCambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
RECRUITINGRoyal Free London NHS Foundation Trust
London, United Kingdom
RECRUITINGKing's College Hospital NHS Foundation Trust
London, United Kingdom
RECRUITINGSafety and Tolerability
Incidence of protocol defined Dose Limiting Toxicities (DLTs).
Time frame: 28 Days post infusion
Long-term safety
Incidence and grade of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) according to CTCAE V5.0.
Time frame: Day of infusion through to Week 82 and up to 15 years post infusion
Immunosuppression related outcome
Ability to withdraw immunosuppression (IS) as measured by the percentage of subjects who have stable Liver Function Tests and are IS free at two months and at one year following IS withdrawal.
Time frame: 2 months and 1 year post withdrawal of immune suppression
Tolerance related outcome
Ability to achieve operational tolerance as measured by the proportion of subjects meeting the clinical, biochemical and histological operational tolerance criteria at one year following IS withdrawal.
Time frame: 1 year following immune suppression withdrawal
Composite efficacy failure outcome
Proportion of subjects with composite event: acute rejection (AR), biopsy proven acute rejection (BPAR), reintroduction of IS or graft loss.
Time frame: 1 year following immune suppression withdrawal
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