Phase I/II study of QEL-001 in A2-mismatch liver transplant patients
Research type
Research Study
Full title
A single-arm, open-label, multi-centre, phase I/II study evaluating the safety and clinical activity of QEL-001, an autologous CAR T regulatory cell treatment targeting HLA-A2, in HLA-A2/ A28neg patients that have received an HLA-A2pos liver transplant
IRAS ID
1003731
Contact name
David Collin
Contact email
Sponsor organisation
Quell Therapeutics Limited
Eudract number
2021-001379-18
Research summary
The study seeks to test whether QEL-001 will work in subjects who have had a liver transplant, from 1 year to 5 years ago, and who have not experienced an episode of rejection in the last year, and who are currently taking immunosuppressant drug(s) to ensure their body does not reject the transplant. Immunosuppressant drugs are non-specific and are also associated with substantial risks that can have a significant impact on a subject's life expectancy and quality of life, as they need to be taken for a long time post-transplant, often for life, because the suppression of the immune system must be maintained. The proposed study treatment, QEL-001, involves collecting the subject's white blood cells using a process of cell harvesting, known as leukapheresis. Once collected these cells are then modified and multiplied in a laboratory before giving the cells back to the subject via an intravenous infusion. This process is used to introduce a specific kind of modified "regulating" cell (Treg) to the subject which can specifically recognise their transplanted liver and reduce the effect of their immune system rejecting the transplant. QEL-001 may therefore be an alternative and safer treatment than conventional immunosuppressant drugs. The study intends to assess if QEL-001 is safe, how subjects react to a single infusion of QEL-001, if QEL-001 has the expected effect on subjects after stopping immunosuppressant therapy, the effect of QEL-001 on subjects and their health overt several years after receiving the treatment.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
21/SC/0255
Date of REC Opinion
25 Oct 2021
REC opinion
Further Information Favourable Opinion