Clincosm LogoSign in Get a demo

CARPERS: Determining the Mechanisms of Loss of CAR T Cell Persistence

Sponsor
University College, London (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05809284
Collaborator
(none)
50
Enrollment
30.1
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Determining the Mechanisms of Loss of CAR T Cell Persistence
    Anticipated Study Start Date :
    May 31, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2025
    Anticipated Study Completion Date :
    Dec 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 25 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University College, London

    Investigators

    • Study Chair: Persis Amrolia, BSc,MBBS,PhD, UCL Institute of Child Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University College, London
    ClinicalTrials.gov Identifier:
    NCT05809284
    Other Study ID Numbers:
    • UCL/156503
    First Posted:
    Apr 12, 2023
    Last Update Posted:
    Apr 12, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Leukemia
    Precursor Cell Lymphoblastic Leukemia-Lymphoma
    Leukemia, Lymphoid

    Study Results

    No Results Posted as of Apr 12, 2023