CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 42 target
Drug / intervention
NK-92/5.28.z +1 morebiological
Likely dose
Ezabenlimab 240mgfrom record
Key inclusion· 8
  • ✓Recurrent or refractory HER2-positive glioblastoma or gliosarcoma with planned relapse surgery or biopsy
  • ✓Age ≥18 years
  • ✓Life expectancy ≥3 months
  • ✓Karnofsky performance score ≥70%
Key exclusion· 16
  • ✕Anti-angiogenic therapy (e.g., bevacizumab) within 4 weeks prior to study entry
  • ✕Previous anti-PD-1 or anti-PD-L1 checkpoint inhibitor therapy (CAR2BRAIN-Check cohort only)
  • ✕Coagulation disorder (INR>1.4 or PTT>50sec) or therapeutic anticoagulation
  • ✕History of autoimmune disease including myasthenia gravis, myositis, autoimmune hepatitis, SLE, rheumatoid arthritis, IBD, vascular thrombosis, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03383978
NCT03383978Phase 1RecruitingOn TrackUpdated 2mo ago
Long Recruiting
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Multicenter, Open Label, Phase I Study of Intracranial Injection of NK-92/5.28.z Cells in Patients With Recurrent HER2-positive Glioblastoma

Johann Wolfgang Goethe University Hospital·interventional·Posted Dec 27, 2017·Updated Apr 23, 2026

In Brief

A Phase 1 clinical trial evaluating NK-92/5.28.z and Ezabenlimab for Glioblastoma. Currently recruiting, targeting 42 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlioblastoma
CountriesGermany
CollaboratorsDRK Blutspendedienst Baden-Württemberg-Hessen gGmbH, Georg-Speyer-Haus, LOEWE Center Frankfurt Cancer Institute, German Cancer Research Center

Timeline

Phase 1Recruiting
20182019202020212022202320242025202620272028
First PostedDec 27, 2017
Enrollment StartDec 1, 2017
Primary CompletionDec 31, 2027
Study CompletionJun 30, 2028
TodayJul 2, 2026
Enrollment to primary: 10.1 yearsPosted 8.5 years agoPrimary completion in 1.5 years

Interventions

NK-92/5.28.zbiological

Intracranial application of NK-92/5.28.z, 1x10E7-1x10E8

Ezabenlimabdrug

Intravenous infusion of Ezabenlimab 240mg q 3 weeks