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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05007379

Acronym

CARMA

Enrollment

100

Registered

2021-08-16

Start date

2021-11-02

Completion date

2027-12-01

Last updated

2026-03-18

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

Conditions

Breast Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

France

Contacts

CONTACTNawale HAJJAJI, MD PhD

n-hajjaji@o-lambret.fr+33 320295910

Outcome results