Determining the Mechanisms of Loss of CAR T Cell Persistence

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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Key information

Conditions

Acute Lymphoblastic Leukemia With Failed Remission Acute Lymphoblastic Leukemia Not Having Achieved Remission Acute Lymphoblastic Leukemia, Adult Acute Lymphoblastic Leukemia, Pediatric Acute Lymphoblastic Leukemia, in Relapse Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

Up to 25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Great Ormond Street Hospital, London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Time to circulating CAR-T cell loss

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

CARPERS Trial Manager

CONTACT

[email protected]

442031084189

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Acronym: CARPERS

Important dates

Study start: 2023
Primary completion: 2027
Study completion: 2027
First posted: Apr 12, 2023
Registry last updated: Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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