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Recruiting NCT05809284
Determining the Mechanisms of Loss of CAR T Cell Persistence
Trial Parameters
Condition Acute Lymphoblastic Leukemia With Failed Remission
Sponsor University College, London
Study Type OBSERVATIONAL
Phase N/A
Enrollment 50
Sex ALL
Min Age N/A
Max Age 25 Years
Start Date 2023-10-18
Completion 2025-12-01
Brief Summary
A prospective observational study of pediatric and young adult acute lymphoblastic leukaemia (ALL) patients treated with CD19 chimeric antigen receptor T-cells (CAR-T cells). The study will examine changes in CAR-T persistence over time and causal factors.
Eligibility Criteria
Inclusion Criteria: 1. Children and young adults (age 25 years or younger) with relapsed/refractory ALL 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 adhere to the protocol