Determining the Mechanisms of Loss of CAR T Cell Persistence

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05809284

Acronym

CARPERS

Enrollment

Registered

2023-04-12

Start date

2023-10-18

Completion date

2027-07-01

Last updated

2026-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 25 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United Kingdom

Contacts

CONTACTCARPERS Trial Manager

ctc.carpers@ucl.ac.uk442031084189

STUDY_CHAIRPersis Amrolia, BSc,MBBS,PhD

UCL Institute of Child Health

Outcome results