drugset
drugset / Trial / NCT03383978

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

NCT03383978 ↗

Phase 1 Recruiting 42 enrolled Johann Wolfgang Goethe University Hospital DRK Blutspendedienst Baden-Württemberg-Hessen gGmbH · collabGeorg-Speyer-Haus · collabGerman Cancer Research Center · collabLOEWE Center Frankfurt Cancer Institute · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2017-12-01
Primary completion
2027-12-31
Completion
2028-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Ezabenlimab Monoclonal antibody 240 mg Intravenous
Subject NK-92/5.28.z Cell therapy 1e+07 cells Other
Subject NK-92/5.28.z Cell therapy 1e+08 cells Other

Indications

glioblastoma