New Antigens Against Glioblastoma (INAAG)

July 21, 2023 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Identification of New Antigens Against Glioblastoma

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

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

National monocentric study, enrolling approximately 120 patients with glioblastoma, males and females, no pedriatic age.

Description

Inclusion Criteria:

  • age > 18 years;
  • Written informed consent

Exclusion Criteria:

  • Not-availability of informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of the tumour specificity of the identified monoclonal antibodies
Time Frame: 4 years
Candidate monoclonal antibodies will be tested by immunohistochemistry (IHC) on sections of glioblastoma tissue and healthy counterpart.
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generate the single chain Fab antibody fragments (scFv) and then develop the Chimeric Antigen Receptor (CAR) T cells
Time Frame: 4 years
After defining a subset of potentially highly selective ~7 monoclonal antibodies, 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
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

June 15, 2023

First Submitted That Met QC Criteria

June 15, 2023

First Posted (Actual)

June 26, 2023

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5866

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glioblastoma Multiforme

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe