Determining the Mechanisms of Loss of CAR T Cell Persistence

ConditionsAcute 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

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

AgeUp to 25

SponsorUniversity College, London

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

The study population is paediatric and young adult patients aged 25 or younger who have relapsed/refractory B-cell acute lymphoblastic leukaemia.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

Time to circulating CAR-T cell loss

CAR-T persistence will be measured in the central lab from blood samples.

Time frame

Through study completion, until the last patient reaches 1 year post-infusion

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University College, London

Lead sponsor

Source ClinicalTrials.gov

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