Intracranial Injection of NK-92/​5.28.z Cells in Combination With Intravenous Ezabenlimab in Patients With Recurrent HER2-positive Glioblastoma (CAR2BRAIN)

Phase 1

Recruiting

• Conditions: Glioblastoma
• Interventions: Biological: NK-92/5.28.z; Drug: Ezabenlimab

• Registration Number: 2024-511988-29-01
• Lead Sponsor: Goethe University Frankfurt

Brief Summary

The main objective of this clinical study is to evaluate the safety and tolerability of NK-92/5.28.z and to determine the maximum tolerated dose or maximum feasible dose (MFD). Recommended phase 2 doses both for intraoperative injections only (RP2Diio) and repetitive injections (RP2Dri) will be determined. Frequent side effects and target organs of toxicity and their severity, duration and reversibility will be determined. Furthermore, pharmacokinetics and pharmacodynamics will be examined. In addition, potential signs of anti-tumor activity of NK-92/5.28.z cells will be analyzed. In the separate "CAR2BRAIN-Check" cohort, combination therapy of NK-92/5.28.z with the anti-PD-1 antibody Ezabenlimab (BI 754091) will be tested.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-10-24
• Last Update Posted: 2025-06-27

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NK-92/5.28.z + Ezabenlimab	NK-92/5.28.z	Intracranial application of NK-92/5.28.z, 1x10E7-1x10E8; intravenous infusion of Ezabenlimab 240mg q 3 weeks
NK-92/5.28.z + Ezabenlimab	Ezabenlimab	Intracranial application of NK-92/5.28.z, 1x10E7-1x10E8; intravenous infusion of Ezabenlimab 240mg q 3 weeks

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03.	24 weeks
Period of detectability of NK-92/5.28.z cells in blood and cerebrospinal fluid (CSF) during the first 24 weeks after NK-92/5.28.z application with qPCR.	24 weeks	qPCR detection of NK-92/5.28.z in blood or CSF
Cytokine profile in the blood and the cerebrospinal fluid.	24 weeks
Maximum tolerated dose (MTD) or maximum feasible dose (MFD) for NK-92/5.28.z	24 weeks

Secondary Outcome Measures

Name	Time	Method
Progression-free survival.	24 weeks
Objective response rate.	24 weeks
NK-92- and/or CAR 5.28.z-directed immune response.	24 weeks
Overall survival.	24 weeks

Trial Locations

Locations (4)

Goethe University Frankfurt; 🇩🇪 Frankfurt Am Main, Germany

Heidelberg University; 🇩🇪 Mannheim, Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR; 🇩🇪 Mainz, Germany

Universitaetsklinikum Heidelberg AöR; 🇩🇪 Heidelberg, Germany

Goethe University Frankfurt

🇩🇪Frankfurt Am Main, Germany

Michael Burger

Site contact

+4969630187711

burger@med.uni-frankfurt.de