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NCT Number: NCT05007379

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oscar Lambret Center

Lille, 59000, France

Location status: Recruiting

Location contact

Nawale Hajjaji, MD, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 24 months

    Measurement of the phagocytic capacity

  2. Antitumor activity of the CAR-macrophages compared to non-modified macrophages

    Time frame: 24 months

    Measurement of the phagocytic capacity

Secondary outcomes

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

    Time frame: 24 months

    Measurement of the phagocytic capacity

Study contacts

Contact information is provided by the study sponsor or research team.

Nawale HAJJAJI, MD PhD

CONTACT

[email protected]

+33 320295910

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

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

Acronym: CARMA

Important dates

Study start
2021
Primary completion
2023
Study completion
2027
First posted
Aug 16, 2021
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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