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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Nawale HAJJAJI, MD PhD; Phone Number: +33 320295910; Email: n-hajjaji@o-lambret.fr

Study Locations

• France
  • Lille, France, 59000
    • Recruiting
    • Oscar Lambret Center
    • Contact: Nawale Hajjaji, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This is a cohort study conducted in breast cancer patients requiring a surgery or a tumor biopsy as part of their care.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antitumor activity of the CAR-macrophages against organoids from HER2 negative, HER2 low and HER2 positive breast cancers	Measurement of the phagocytic capacity	24 months
Antitumor activity of the CAR-macrophages compared to non-modified macrophages	Measurement of the phagocytic capacity	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antitumor activity of the CAR-macrophages against organoids from early and advanced breast cancers patients	Measurement of the phagocytic capacity	24 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Actual): September 1, 2023
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: August 11, 2021
• First Submitted That Met QC Criteria: August 11, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: CARMA-2101; 2021-A00670-41 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No