CARD
Research type
Research Study
Full title
CAR19 Donor Lymphocytes for relapsed CD19+ malignancies following allogeneic transplantation
IRAS ID
200484
Contact name
Nick McNally
Contact email
Sponsor organisation
University College London
Eudract number
2016-001869-85
Duration of Study in the UK
4 years, 11 months, 30 days
Research summary
Most patients with CD19+ malignancies have poor prognosis once their disease comes back following an allogeneic transplant. As standard, where they are free from graft-versus-host disease (GvHD), they are offered unmanipulated donor lymphocytes (a particular type of immune cells in the blood that kills cancer cells). This approach however, has little effect in these malignancies and most patients still end up developing GvHD without any tangible clinical benefit.
In this study, adult (aged 16-70 years) patients who have relapsed after an allogeneic transplant, will be given lymphocytes which have been genetically modified (CAR19 T-cells) in an escalating dose regimen so that they can specifically fight cancer cells expressing CD19. The lymphocytes are initially given at a smaller dose and gradually increases in the absence of a response and toxicities. They each would receive a maximum of 3 doses. Patients have been shown to respond to such modified lymphocytes adult patients with different types of cancers of the immune system as well as patients relapsing after an allogeneic transplant. Most of these early stage studies are ongoing at the moment, but early results are very encouraging.
Our study aims to assess whether the modified cells can be made using an automated system and to see if they are safe.REC name
London - West London & GTAC Research Ethics Committee
REC reference
16/LO/1721
Date of REC Opinion
1 Dec 2016
REC opinion
Further Information Favourable Opinion