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INAAG: New Antigens Against Glioblastoma

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05917821
Collaborator
(none)
120
Enrollment
51
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

In this study the investigators will select and develop potential therapeutic monoclonal antibodies for GB. Activities include tissue microarray (TMA) to test mAbs specificity and target distribution, selection of GB-specific functional mAbs, identification of candidate targets.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Identification of New Antigens Against Glioblastoma
    Anticipated Study Start Date :
    Jul 1, 2023
    Anticipated Primary Completion Date :
    Jul 30, 2027
    Anticipated Study Completion Date :
    Sep 30, 2027

    Outcome Measures

    Primary Outcome Measures

    1. Validation of the tumour specificity of the identified mAbs [4 years]

      Candidate mAbs will be tested by immunohistochemistry (IHC) on sections of GB tissue and healthy counterpart.

    Secondary Outcome Measures

    1. Generate the scFvs (single chain Fab antibody fragments) and then develop the CAR T cells [4 years]

      After defining a subset of potentially highly selective ~7 mAbs, together with the ~6 that showed preliminary activity in cytotoxic tests (either alone or conjugated), the investigators will perform a thorough analysis of their specificity on a TMA platform. After establishing the staining conditions, the investigators will test multiple tumor and multiple normal TMAs

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • age > 18 years;

    • Written informed consent

    Exclusion Criteria:
    • Not-availability of infomed consent

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    ClinicalTrials.gov Identifier:
    NCT05917821
    Other Study ID Numbers:
    • 5866
    First Posted:
    Jun 26, 2023
    Last Update Posted:
    Jun 26, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Glioblastoma

    Study Results

    No Results Posted as of Jun 26, 2023