Determining the mechanisms of loss of CAR-T cell persistence
Description
Design:
CARPERS is an observational study aiming to analyse CAR-T cell persistence over time. It will be offered to patients with CD19-positive acute lymphoblastic leukaemia who will receive the commercially available CAR-T cell therapy tisagenlecleucel (Kymriah). We will take blood samples and the remains of the tisagenlecleucel product bag after the CAR-T infusion in order to determine whether immune responses against the CAR-T cells and the cellular composition of the product bag (which is unique to each individual) are associated with CAR-T persistence in the blood, disease relapse, event-free survival and/or CD19 status.
Treatment:
Tisagenlecleucel will be administered as standard of care by the hospital and not as part of this study.
Key inclusion/exclusion criteria:
Inclusion criteria
1. Children and young adults (age 25 years or younger) with relapsed/refractoryALL who are planned to receive licensed CD19-targeted CAR-T cell treatment(Tisagenlecleucel)
2. Written informed consent
Exclusion criteria
1. Patients receiving an alternate CD19-directed CAR T-cell product on a clinical trial
2. Any reason that in the opinion of the investigator, patients won’t be able to adhereto the protocol
Duration of recruitment:
2.5 years
Aim
Tisagenlecleucel has been shown to be highly effective in treating leukaemias and lymphomas that haven’t responded or came back after standard chemotherapy. CAR-T cells work for around 80 to 90% of patients initially, however in half of them the response is not long-lasting, and leukaemia returns. This study aims to find out why which may lead to ways of making CAR-T cell therapy working for longer.