Trial Details
Trial status:
In set-up (funded)
Recruitment start date:
Great Ormond Street Hospital Children's Charity (GOSHCC)
Chief Investigator:
Professor Persis Amrolia
Recruitment target:
EudraCT number:
Contact details:
Lay summary:
Determining the mechanisms of loss of CAR-T cell persistence
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
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.
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
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