Test of CD47-SIRPα Inhibitors on the Immune Microenvironment Colon Cancer
ConditionCancer of the Colon
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut Paoli-Calmettes
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The population studied concerns patients over the age of 18, suffering from colon cancer, undergoing immediate surgery or after chemotherapy.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
BLOOD AND TUMOR
Procedure/Surgerysampling of 24 ml of peripheral blood and samples of colon cancers with healthy tissue in parallel on the surgery piece
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
18 months from study launchSecondary outcomes
1
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.
Time frame
18 months from study launch2
Generate a T cell biobank by FACS isolating T cells using the CD3 surface marker directed against the human form
Time frame
48 month3
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)
Time frame
48 monthSponsors and contacts
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Source ClinicalTrials.gov