Actively Recruiting
Intracranial Injection of NK-92/5.28.z Cells in Combination With Intravenous Ezabenlimab in Patients With Recurrent HER2-positive Glioblastoma
Led by Johann Wolfgang Goethe University Hospital · Updated on 2026-04-23
42
Participants Needed
5
Research Sites
552 weeks
Total Duration
On this page
Sponsors
J
Johann Wolfgang Goethe University Hospital
Lead Sponsor
D
DRK Blutspendedienst Baden-Württemberg-Hessen gGmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Intracranial Injection of NK-92/5.28.z Cells in Combination With Intravenous Ezabenlimab in Patients With Recurrent HER2-positive Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Recurrent or refractory HER2-positive glioblastoma or gliosarcoma with planned relapse surgery or biopsy
- Prior standard radiotherapy and alkylating chemotherapy for glioblastoma (exceptions for non-methylated MGMT-Promotor patients)
- Life expectancy of at least 3 months
- Liver enzymes and kidney function within specified limits
- Leukocyte count ≥ 3/nl, thrombocyte count ≥ 100/nl, and hemoglobin ≥ 8.0 g/dl
- Blood oxygenation ≥ 90% on room air
- Negative serum pregnancy test for women within 72 hours before first injection
- Willingness to use effective contraception during and for 24 weeks after treatment
- Off other antineoplastic therapy for at least two weeks before study entry
- Karnofsky performance score ≥ 70%
You will not qualify if you...
- Anti-angiogenic therapy within 4 weeks before study entry
- Prior anti-PD-1 or anti-PD-L1 checkpoint inhibitor therapy (for the combination therapy cohort)
- Coagulation disorders or therapeutic anticoagulation
- History of autoimmune diseases except stable hypothyroidism under treatment
- Unstable Type I diabetes mellitus
- Psoriatic arthritis or uncontrolled dermatologic conditions
- Immunodeficiency or immunosuppressive medication other than corticosteroids
- Severe infections
- Known HIV, HBV, or HCV infection
- Severe chronic heart failure (NYHA class III or higher)
- Previous solid organ or stem cell transplantation
- Unable to undergo MRI
- Pregnancy or breastfeeding
- Drug or alcohol abuse
- Severe psychiatric disorders affecting study participation
- Concurrent participation in another interventional clinical trial or recent investigational medication use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Neurochirurgische Klinik, Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
2
Neurochirurgische Klinik, Universitätsmedizin Mannheim
Mannheim, Baden-Wurttemberg, Germany, 68167
Actively Recruiting
3
Neurochirurgische Klinik, Universitätsmedizin Mainz
Mainz, Rhineland-Palatinate, Germany, 55131
Actively Recruiting
4
Johann W. Goethe University Hospital, Department of Neurosurgery
Frankfurt, Germany, 60590
Actively Recruiting
5
Johann W. Goethe University Hospital, Senckenberg Institute of Neurooncology
Frankfurt, Germany, 60590
Actively Recruiting
Research Team
M
Michael C Burger, PD Dr. med.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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