Clinical Trial

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

Study acronym: CAR2BRAIN
Recruiting Phase 1
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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" and "CAR2BRAIN-CheckR" cohorts, combination therapy of NK-92/5.28.z with the anti-PD-1 antibody Ezabenlimab (BI 754091) will be tested.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2017-12-19; most recent amendment 2026-04-19.
Status change: Active, Not Recruiting → Recruiting 2026-04-19
Status change: Recruiting → Active, Not Recruiting 2024-03-26
Trial Details
NCT Number NCT03383978
Lead Sponsor Johann Wolfgang Goethe University Hospital
Collaborators: DRK Blutspendedienst Baden-Württemberg-Hessen gGmbH, Georg-Speyer-Haus, LOEWE Center Frankfurt Cancer Institute, German Cancer Research Center
Conditions Glioblastoma
Enrollment 42 participants
Start Date 2017-12-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-23