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

NCT03383978 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-04-23

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

NK-92/5.28.z

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

DRUG

Ezabenlimab

Intravenous infusion of Ezabenlimab 240mg q 3 weeks

Sponsors & Collaborators

  • DRK Blutspendedienst Baden-Württemberg-Hessen gGmbH

    collaborator UNKNOWN

  • Georg-Speyer-Haus

    collaborator UNKNOWN

  • LOEWE Center Frankfurt Cancer Institute

    collaborator UNKNOWN

  • German Cancer Research Center

    collaborator OTHER

  • Johann Wolfgang Goethe University Hospital

    lead OTHER

Principal Investigators

  • Michael C Burger, PD Dr. med. · Johann W. Goethe University Hospital, Frankfurt am Main, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03383978 on ClinicalTrials.gov