NCT05917821

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
17mo left

Started Aug 2023

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Aug 2023Sep 2027

First Submitted

Initial submission to the registry

June 15, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

July 24, 2023

Status Verified

May 1, 2023

Enrollment Period

4 years

First QC Date

June 15, 2023

Last Update Submit

July 21, 2023

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

  • Validation of the tumour specificity of the identified monoclonal antibodies

    Candidate monoclonal antibodies will be tested by immunohistochemistry (IHC) on sections of glioblastoma tissue and healthy counterpart.

    4 years

Secondary Outcomes (1)

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

    4 years

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • age \> 18 years;
  • Written informed consent

You may not qualify if:

  • Not-availability of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2023

First Posted

June 26, 2023

Study Start

August 1, 2023

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

July 24, 2023

Record last verified: 2023-05