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CARMA: Cohort Study to Determine the Antitumor Activity of New CAR-macrophages in Breast Cancer Patients' Derived Organoids

Sponsor
Centre Oscar Lambret (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05007379
Collaborator
Institut National de la Santé Et de la Recherche Médicale, France (Other)
100
Enrollment
24
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Cell-based immune therapy using modified macrophages is a promising therapeutic approach in breast cancer. The objective of this cohort study is to collect tumor samples to develop patients' derived organoids to test the antitumor activity of newly developed CAR-macrophages. Other biological samples will be collected such as blood to analyze the host inflammatory status.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Cohort Study to Determine the Antitumor Activity of New CAR-macrophages in Breast Cancer Patients' Derived Organoids (CARMA)
    Anticipated Study Start Date :
    Sep 1, 2021
    Anticipated Primary Completion Date :
    Sep 1, 2023
    Anticipated Study Completion Date :
    Sep 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Antitumor activity of the CAR-macrophages against organoids from HER2 negative, HER2 low and HER2 positive breast cancers [24 months]

    2. Antitumor activity of the CAR-macrophages compared to non-modified macrophages [24 months]

    Secondary Outcome Measures

    1. Antitumor activity of the CAR-macrophages against organoids from early and advanced breast cancers patients [24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male or female aged 18 years or more

    • Histologically confirmed breast cancer at any stage

    • Requiring surgery or tumor biopsy as standard of care

    • Any or no systemic treatment

    • Signed informaed consent

    • Health insurance coverage

    Exclusion Criteria:
    • Opposed to biospecimen collection

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Centre Oscar Lambret
    • Institut National de la Santé Et de la Recherche Médicale, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Oscar Lambret
    ClinicalTrials.gov Identifier:
    NCT05007379
    Other Study ID Numbers:
    • CARMA-2101
    First Posted:
    Aug 16, 2021
    Last Update Posted:
    Aug 16, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Aug 16, 2021