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NCT05007379 Clinical Trial

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

Breast Cancer Clinical Trial

— CARMA  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05007379
Other study ID # CARMA-2101
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date September 1, 2023

Study information
Verified date August 2021
Source Centre Oscar Lambret
Contact Nawale HAJJAJI, MD PhD
Phone +33 320295910
Email n-hajjaji@o-lambret.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date September 1, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Centre Oscar Lambret Institut National de la Santé Et de la Recherche Médicale, France

Outcome
Type Measure Description Time frame Safety issue
Primary Antitumor activity of the CAR-macrophages against organoids from HER2 negative, HER2 low and HER2 positive breast cancers 24 months
Primary Antitumor activity of the CAR-macrophages compared to non-modified macrophages 24 months
Secondary Antitumor activity of the CAR-macrophages against organoids from early and advanced breast cancers patients 24 months
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