Determining the Mechanisms of Loss of CAR T Cell Persistence

University College, London50 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

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

Eligibility

Sex: ALLMax age: 25 Years

Medical Language ↔ Plain English

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)

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

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

Determining the Mechanisms of Loss of CAR T Cell Persistence

Overview

Conditions

Eligibility

Locations (3)

Outcomes

Primary Outcomes

Central Contacts