New Antigens Against Glioblastoma

Not yet recruiting

• Conditions: Glioblastoma Multiforme

• Registration Number: NCT05917821
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-06-15
• Study First Submitted QC: 2023-06-15
• Study First Posted: 2023-06-26
• Last Update Submitted: 2023-07-21
• Last Update Posted: 2023-07-24
• Study Start: 2023-08-01
• Primary Completion: 2027-07-30
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• age > 18 years;
• Written informed consent

Exclusion Criteria

• Not-availability of informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Generate the single chain Fab antibody fragments (scFv) and then develop the Chimeric Antigen Receptor (CAR) T cells	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