Long-term follow-up study of patients previously exposed to UCART19
Research type
Research Study
Full title
Long-term follow-up study of patients who have previously been exposed to UCART19 /ALLO-501 (allogeneic engineered T-cells expressing a lentiviral-based anti-CD19 chimeric antigen receptor)
IRAS ID
200596
Contact name
Valerie Fautrier
Contact email
Sponsor organisation
Institut de Recherches Internationales Servier (IRIS)
Eudract number
2016-000297-38
Duration of Study in the UK
23 years, 7 months, 31 days
Research summary
The aim of this study is to follow the long-term safety of patients who have previously received UCART19 cells as treatment for advanced B-cell leukaemia. All children and adults who have taken part in trials or who have received UCART19 cells as ‘compassionate use’ will be invited to take part. The anti-leukaemic activity of UCART19 will also be monitored.
UCART19 is an experimental new therapy involving cells from the immune system that have been genetically modified and designed to fight leukaemia. The cells are T-cells, which are important white blood cells, involved in fighting infection. They are collected from a healthy donor and then changed in several ways. A receptor is added so that the UCART19 cells can recognise a marker on the B leukaemia cells, an interaction that leads to the death of the leukaemia cell (and normal B-cells). The receptor is called a chimeric antigen receptor (CAR) and a disabled virus is used to add the genetic code for the CAR.
All patients will be followed for at least 3 years and up to 15 years after UCART19 treatment. Three study visits are planned during the first year, then visits occur every 6 months until year 3 and then annually up to 15 years. Patients will be monitored for possible long-term side effects of UCART19. At all visits blood samples will be taken to monitor the continued presence of UCART19 cells and potential side effects such as low levels of B-cells and the possible re-activation of the virus used to create the CAR. If no UCART19 related side-effects or cells has been detected during the first 3 years the patients may stop the study. If UCART19 or virus is detected patients will be followed for up to 15 years and more extensive follow-up may be undertaken.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
16/LO/0663
Date of REC Opinion
22 Jun 2016
REC opinion
Further Information Favourable Opinion