Clinical trial • Phase III • Neurology|Rare Disease

NK-92/5.28.z cells for Glioblastoma|HER2-positive glioblastoma|Recurrent glioblastoma

Phase III trial of NK-92/5.28.z cells for Glioblastoma|HER2-positive glioblastoma|Recurrent glioblastoma. 42 participants.

Overview

Trial Therapeutic Area
Neurology|Rare Disease
Trial Disease
Glioblastoma|HER2-positive glioblastoma|Recurrent glioblastoma
Trial Stage
Phase III
Drug Modality
Cell therapy|Monoclonal antibody

Key dates

Initial CTIS Submission Date
11-10-2024
First CTIS Authorization Date
24-10-2024

Trial design

Phase III trial across 4 sites in Germany.

Target Sample Size
42

Eligibility

Recruits 42 No vulnerable populations selected (isVulnerablePopulationSelected=false). No information provided on consent or assent processes in the available record..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected=false). No information provided on consent or assent processes in the available record.

Recruitment

Planned Sample Size
42
Recruitment Window Months
33

Geography

Total Number Of Sites
4
Total Number Of Participants
42

Germany

Earliest CTIS Part Ii Submission Date
11-10-2024
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
566
Number Of Sites
4
Number Of Participants
42

Sites

Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Neurochirurgische Klinik und Poliklinik
Principal Investigator Name
Jens Conrad
Principal Investigator Email
jens.conrad@unimedizin-mainz.de
Contact Person Name
Jens Conrad
Site Name
Goethe University Frankfurt
Department Name
Dr. Senckenberg Institute for Neurooncology
Principal Investigator Name
Michael Burger
Principal Investigator Email
burger@med.uni-frankfurt.de
Contact Person Name
Michael Burger
Contact Person Email
burger@med.uni-frankfurt.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Department of Neurosurgery
Principal Investigator Name
Sandro Krieg
Principal Investigator Email
sandro.krieg@med.uni-heidelberg.de
Contact Person Name
Sandro Krieg
Site Name
Heidelberg University
Department Name
Neurochirurgische Klinik Universitätsmedizin Mannheim
Principal Investigator Name
Miriam Ratliff
Principal Investigator Email
Miriam.Ratliff@umm.de
Contact Person Name
Miriam Ratliff
Contact Person Email
Miriam.Ratliff@umm.de

Sponsor

Primary sponsor

Full Name
Goethe University Frankfurt
Organisation Type
Educational Institution
Country Of Registered Address
Germany

Investigational products

Investigational Product Name
NK-92/5.28.z Cells
Active Substance
NK-92/5.28.z cells
Modality
Cell therapy
Routes Of Administration
Intracranial injection
Route
Intracranial injection
Investigational Product Name
Ezabenlimab
Active Substance
Ezabenlimab
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
Combination Treatment
Yes

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