Determining the Mechanisms of Loss of CAR T Cell Persistence

NCT05809284 — Recruiting, 50 participants, University College, London

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Registry	NCT05809284, acronym CARPERS
Status	Recruiting
Study type	Observational
Enrollment	50 (Estimated)
Sponsor	University College, London (Other)
Conditions	Acute Lymphoblastic Leukemia With Failed Remission, Acute Lymphoblastic Leukemia Not Having Achieved Remission, Acute Lymphoblastic Leukemia, Pediatric, Acute Lymphoblastic Leukemia, Adult, Acute Lymphoblastic Leukemia, in Relapse
Dates	start 2023-10-18, primary completion 2027-07-01 (estimated), completion 2027-07-01 (estimated), first posted 2023-04-12, last updated 2026-08-07
Locations	3 sites in United Kingdom

-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.

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+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: All, ages: any to 25 Years

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

+Locations (3)

Facility	City	Country	Status
Great Ormond Street Hospital	London	United Kingdom	Recruiting
University College London Hospital	London	United Kingdom	Recruiting
Royal Manchester Children's Hospital	Manchester	United Kingdom	Recruiting

+Investigators

Persis Amrolia, BSc,MBBS,PhD, Study chair, UCL Institute of Child Health