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NCT Number: NCT05955196

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

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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Key information

Conditions

Cancer of the Colon Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Establishment of patient derived organoids (minimum n=30) resembling the primary tissue sample

    Time frame: 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

  1. Establishment of a validated cryobank of patient derived organoids (minimum n=30)

    Time frame: 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.

  2. Generate a T cell biobank by FACS isolating T cells using the CD3 surface marker directed against the human form

    Time frame: 48 month

  3. 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 month

Study contacts

Contact information is provided by the study sponsor or research team.

Dominique GENRE, MD

CONTACT

[email protected]

+33491223778

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Acronym: MACROSWITCH

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Jul 21, 2023
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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