Determining the Mechanisms of Loss of CAR T Cell Persistence (CARPERS)

University College London (UCL)

Status: Enrolling

Conditions: Acute Lymphoblastic Leukemia, Adult; Acute Lymphoblastic Leukemia With Failed Remission; Acute Lymphoblastic Leukemia, Pediatric; Acute Lymphoblastic Leukemia Not Having Achieved Remission; Acute Lymphoblastic Leukemia, in Relapse

Study type: Observational

Funder types: Other

Identifiers

NCT05809284

UCL/156503

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: Under 25 years old

Volunteers: No Healthy Volunteers

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