Determining the Mechanisms of Loss of CAR T Cell Persistence
Recruiting
- Conditions
- Acute Lymphoblastic Leukemia, AdultAcute Lymphoblastic Leukemia With Failed RemissionAcute Lymphoblastic Leukemia Not Having Achieved RemissionAcute Lymphoblastic Leukemia, PediatricAcute Lymphoblastic Leukemia, in Relapse
- Registration Number
- NCT05809284
- Lead Sponsor
- University College, London
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- 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)
- Written informed consent
Exclusion Criteria
- Patients receiving an alternate CD19-directed CAR T-cell product on a clinical trial
- Any reason that in the opinion of the investigator, patients won't be able to adhere to the protocol
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to circulating CAR-T cell loss Through study completion, until the last patient reaches 1 year post-infusion CAR-T persistence will be measured in the central lab from blood samples.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Great Ormond Street Hospital
🇬🇧London, United Kingdom
Royal Manchester Children's Hospital
🇬🇧Manchester, United Kingdom
University College London Hospital
🇬🇧London, United Kingdom