CALM study: UCART19 in adults with B-cell malignancies
Research type
Research Study
Full title
Phase I, open label, dose-escalation study to evaluate the safety, expansion, persistence and biological activity of a single dose of UCART19 (allogeneic engineered T-cells expressing anti-CD19 chimeric antigen receptor), administered intravenously in patients with relapsed or refractory CD19 positive B-cell acute lymphoblastic leukaemia (B-ALL) or chronic lymphocytic leukaemia (CLL)
IRAS ID
200594
Contact name
Marta Garcia
Contact email
Sponsor organisation
Servier Research & Development Ltd
Eudract number
2016-000296-24
Duration of Study in the UK
1 years, 10 months, 30 days
Research summary
This is a first trial of an experimental new therapy involving cells from the immune system that have been genetically modified and designed to fight leukaemia. Adults whose B-cell acute lymphoblastic leukaemia or chronic lymphocytic leukaemia has returned and who have exhausted all treatment options will be included.
The cell therapy is called UCART19. 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. Other changes include removal of a marker that reduces the chance of the patient’s immune cells recognising and killing the foreign UCART19 cell.
The first aim of this study is to test the safety of increasing doses of UCART19 cells. The second aim is to identify the dose of UCART19 that is able to induce remission of the leukaemia. This trial will only take place at Kings College Hospital. Up to 12 patients will be included.
Patients will undergo careful screening to confirm that their leukaemia requires treatment. Prior to giving the UCART19 cells we need to wipe out the patient’s existing immune system. Research indicates that this improves the ability of the T-cells to establish and grow. Then a single infusion of the UCART19 cells will be given. The patients will be closely monitored via blood tests and bone marrow tests for safety reasons and to see what is happening to the UCART19 cells and their leukaemia. We expect patients to be in hospital for around 21 days. Patients will be followed for 3 months and will then be invited to take part in a long-term follow-up study.REC name
London - West London & GTAC Research Ethics Committee
REC reference
16/LO/0662
Date of REC Opinion
4 May 2016
REC opinion
Favourable Opinion