Test of CD47-SIRPα Inhibitors on the Immune Microenvironment Colon Cancer

NCT05955196 — Recruiting, 115 participants, Institut Paoli-Calmettes

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Registry	NCT05955196, acronym MACROSWITCH
Status	Recruiting
Study type	Observational
Enrollment	115 (Estimated)
Sponsor	Institut Paoli-Calmettes (Other)
Conditions	Cancer of the Colon
Interventions	BLOOD AND TUMOR (Procedure)
Dates	start 2023-01-09, primary completion 2025-01-09 (estimated), completion 2027-01-09 (estimated), first posted 2023-07-21, last updated 2024-10-09
Locations	1 site in France

-Summary

Our goal is to create novel CD47-SIRPα inhibitors using small molecules to reverse TAM-mediated immune suppression and restore anti-tumor immunity in CRCs. Our program uses structure-based drug design to create selective and potent small molecule inhibitors of SIRPα-CD47 to target the tumor microenvironment with greater efficacy and lower toxicity than CD47-targeting antibodies. .

In order to study the activity of CD47-SIRPα inhibitors on the immune microenvironment of tumors, we propose to use organoids derived from biopsies of patients with colon cancer. Tumoroids preserve the patient's tumor stroma (including myeloid cells) and provide an accurate in vitro model of complex tumor immune interaction for the evaluation of immunotherapies.

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+Arms and interventions

BLOOD AND TUMOR (Procedure): sampling of 24 ml of peripheral blood and samples of colon cancers with healthy tissue in parallel on the surgery piece

+Outcome measures

Primary outcomes

Establishment of patient derived organoids (minimum n=30) resembling the primary tissue sample [18 months from study launch]: the capacity to establish patient-derived organoids from tumor and adjacent normal tissue will be evaluated using a histology score evaluating and comparing primary and organoid sample characteristics.

Secondary outcomes

Establishment of a validated cryobank of patient derived organoids (minimum n=30) [18 months from study launch]: the capacity to establish a cryobank of patient-derived organoids from tumor and adjacent normal tissue will be evaluated using a growth score evaluating and comparing organoid sample characteristics pre- and post-cryopreservation and amplification through 4 passages.
Generate a T cell biobank by FACS isolating T cells using the CD3 surface marker directed against the human form [48 month]
To assess the effect of immunotherapy on the antitumor activity of autologous T cells from peripheral blood samples using tumor viability measurements (cell titer glo, FACS) [48 month]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Patient over 18 years old
* Patient who has signed a consent to participate;
* Patient with metastatic or non-metastatic colon cancer, or recurrence of colon cancer for whom excision surgery has been proposed;
* Patient affiliated to a social security scheme, or beneficiary of such a scheme

Exclusion Criteria:

* Patient who had emergency colon cancer surgery
* Person in an emergency situation or unable to express their consent.
* Adult subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice),
* Patient unable to submit to the medical follow-up of the trial for geographical, social or psychological reasons

+Locations (1)

Facility	City	Country	Status
Institut Paoli Calmettes	Marseille	France	Recruiting

+Investigators

Cécile de CHAISEMARTIN, MD, Principal investigator, Paoli Calmettes Institute