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

Cancer of the Colon Clinical Trial

— MACROSWITCH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05955196
• Other study ID #: MACROSWITCH-IPC 2021-083
• Status: Recruiting
• Start date: January 9, 2023
• Est. completion date: January 9, 2027

Study information

• Verified date: July 2023
• Source: Institut Paoli-Calmettes
• Contact: Dominique GENRE, MD
• Phone: +33491223778
• Email: drci.up[@]ipc.unicancer.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 115
• Est. completion date: January 9, 2027
• Est. primary completion date: January 9, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of the Colon
• Colonic Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Institut Paoli Calmettes	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establishment of patient derived organoids (minimum n=30) resembling the primary tissue sample	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.	18 months from study launch
Secondary	Establishment of a validated cryobank of patient derived organoids (minimum n=30)	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.	18 months from study launch
Secondary	Generate a T cell biobank by FACS isolating T cells using the CD3 surface marker directed against the human form		48 month
Secondary	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