Intracranial Injection of NK-92/5.28.z Cells in Patients With Recurrent HER2-positive Glioblastoma (CAR2BRAIN)
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ClinicalTrials.gov Identifier: NCT03383978 |
Recruitment Status :
Recruiting
First Posted : December 27, 2017
Last Update Posted : September 25, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glioblastoma | Biological: NK-92/5.28.z | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Multicenter, Open Label, Phase I Study of Intracranial Injection of NK-92/5.28.z Cells in Patients With Recurrent HER2-positive Glioblastoma |
Actual Study Start Date : | December 1, 2017 |
Estimated Primary Completion Date : | September 2022 |
Estimated Study Completion Date : | December 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: NK-92/5.28.z
Intracranial application of NK-92/5.28.z, 1x10E7-1x10E8
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Biological: NK-92/5.28.z
Intracranial application of NK-92/5.28.z, 1x10E7-1x10E8 |
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.03. [ Time Frame: 24 weeks ]
- Maximum tolerated dose (MTD) or maximum feasible dose (MFD). [ Time Frame: 24 weeks ]
- Period of detectability of NK-92/5.28.z cells in blood and cerebrospinal fluid (CSF) during the first 24 weeks after NK-92/5.28.z application with qPCR. [ Time Frame: 24 weeks ]qPCR detection of NK-92/5.28.z in blood or CSF
- Cytokine profile in the blood and the cerebrospinal fluid. [ Time Frame: 24 weeks ]
- NK-92- and/or CAR 5.28.z-directed immune response. [ Time Frame: 24 weeks ]
- Objective response rate. [ Time Frame: 24 weeks ]
- Progression-free survival. [ Time Frame: 24 weeks ]
- Overall survival. [ Time Frame: 24 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Recurrent or refractory HER2-positive glioblastoma or its variant gliosarcoma in which a relapse surgery (partial or total) or a biopsy (patients with a biopsy are only eligible for the escalation cohort) is being planned. In patients with a planned biopsy, a maximum diameter of the contrast-enhancing lesion from which the biopsy will be done of 3 cm measured in the most recent magnetic resonance imaging at the time of enrollment to the study is allowed.
- Prior therapy must include the standard of care for glioblastoma (radiotherapy plus concomitant and adjuvant chemotherapy with temozolomide according to the EORTC 26981 trial or at least a part thereof if the standard therapy was terminated prematurely due to therapy failure or poor tolerance).
- Age ≥ 18 years.
- Life expectancy ≥ 3 months.
- Bilirubin ≤ 3x normal, AST ≤ 5x normal, ALT ≤ 5x, serum creatinine ≤ 2x upper limit of normal for age, leukocyte count 3/nl, thrombocyte count 100/nl and Hb 8.0 g/dl.
- Blood oxygenation of 90% as measured by pulse oximetry on room air.
- Women must have a negative serum pregnancy test within 72h prior to the start of the first NK-92/5.28.z cell injection.
- Sexually active patients must be willing to utilize effective birth control methods throughout the study and for 24 weeks after the last NK-92/5.28.z cell injection. This includes two different forms of effective contraception (e.g. hormonal contraceptive and condom, IUD/IUS and condom) or sterilization.
- Patients should have been off other antineoplastic therapy for two weeks prior to entry in this study. Temozolomide will be allowed up to 48h preinjection. At the the time of inclusion, dexamethasone up to a total dose of 4 mg per day will be allowed if medically indicated.
- Informed consent explained to and signed by patient; patient given copy of informed consent.
- Karnofsky performance score of ≥ 50%.
Exclusion Criteria:
- Anti-angiogenic therapy e.g. with bevacizumab (Avastin®) in the last four weeks prior to study entry.
- Coagulation disorder (INR>1.4 or PTT>50sec) or anticoagulation at therapeutic dosage.
- Active autoimmune disease.
- Patients with clinical or laboratory signs for immunodeficiency or under immunosuppressive medication other than corticosteroids.
- Severe intercurrent infection.
- Known HIV, HBV or HCV positivity.
- Chronic heart failure NYHA ≥III.
- Patients with a prior solid organ transplantation or allogenic haematopoietic stem cell transplantation.
- Unable to undergo MRI.
- Pregnancy or breastfeeding.
- Drug or alcohol abuse.
- Severe psychiatric disorder which might interfere with the study treatment or examination.
- Simultaneous participation in another clinical trial. If a subject participated in a trial testing another IMP, such IMP should have been terminated at least 30 days before inclusion of the subject.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383978
Contact: Michael C Burger, PD Dr. med. | 0049696301 ext 87711 | michael.burger@kgu.de |
Germany | |
Johann W. Goethe University Hospital, Department of Neurosurgery | Recruiting |
Frankfurt, Germany, 60528 | |
Contact: Christian Senft, Prof. Dr. med. 0049696301 ext 5295 christian.senft@kgu.de | |
Johann W. Goethe University Hospital, Senckenberg Institute of Neurooncology | Recruiting |
Frankfurt, Germany, 60528 | |
Contact: Michael C Burger, PD Dr. med. 0049696301 ext 87711 michael.burger@kgu.de | |
Contact: Joachim P Steinbach, Prof. Dr. med. 0049696301 ext 87711 joachim.steinbach@med.uni-frankfurt.de |
Principal Investigator: | Michael C Burger, PD Dr. med. | Johann W. Goethe University Hospital, Frankfurt am Main, Germany |
Responsible Party: | Michael Burger, Principal Investigator, Johann Wolfgang Goethe University Hospital |
ClinicalTrials.gov Identifier: | NCT03383978 |
Other Study ID Numbers: |
EudraCT 2016-000225-39 |
First Posted: | December 27, 2017 Key Record Dates |
Last Update Posted: | September 25, 2020 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |