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

Sponsor
Institut Paoli-Calmettes (Other)
Overall Status
Recruiting
CT.gov ID
NCT05955196
Collaborator
(none)
115
1
48
2.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: BLOOD AND TUMOR

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
115 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Test of CD47-SIRPα Inhibitors on the Immune Microenvironment Colon Cancer
Actual Study Start Date :
Jan 9, 2023
Anticipated Primary Completion Date :
Jan 9, 2025
Anticipated Study Completion Date :
Jan 9, 2027

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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.

  2. Generate a T cell biobank by FACS isolating T cells using the CD3 surface marker directed against the human form [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) [48 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut Paoli Calmettes Marseille France 13009

Sponsors and Collaborators

  • Institut Paoli-Calmettes

Investigators

  • Principal Investigator: Cécile de CHAISEMARTIN, MD, Paoli Calmettes Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:
NCT05955196
Other Study ID Numbers:
  • MACROSWITCH-IPC 2021-083
First Posted:
Jul 21, 2023
Last Update Posted:
Jul 21, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2023