[Information provided by:
ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]
|NCT03383978 : Intracranial Injection of NK-92/5.28.z (HER2.taNK) Cells in Patients With Recurrent HER2-positive Glioblastoma (Quilt 3.C001)|
|Ages||Min: 18 Years Max: N/A|
1. Recurrent or refractory HER2-positive glioblastoma or its variant gliosarcoma in which
a relapse surgery (partial or total) is being planned.
2. Prior therapy must include the standard of care for glioblastoma (radiotherapy plus
concomitant and adjuvant chemotherapy with temozolomide according to the EORTC 26981
3. Age = 18 years.
4. Life expectancy = 3 months.
5. 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.
6. Blood oxygenation of 90% as measured by pulse oximetry on room air.
7. Women must have a negative serum pregnancy test within 72h prior to the start of the
first NK-92/5.28.z cell injection.
8. 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.
9. 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
10. Informed consent explained to and signed by patient; patient given copy of informed
11. Karnofsky performance score of = 50%.
1. Previous anti-angiogenic therapy e.g. with bevacizumab (Avastin).
2. Coagulation disorder (INR>1.4 or PTT>50sec) or anticoagulation at therapeutic dosage.
3. Active autoimmune disease.
4. Patients with clinical or laboratory signs for immunodeficiency or under
immunosuppressive medication other than corticosteroids.
5. Severe intercurrent infection.
6. Known HIV, HBV or HCV positivity.
7. Chronic heart failure NYHA =III.
8. Patients with a prior solid organ transplantation or allogenic haematopoietic stem
9. Unable to undergo MRI.
10. Pregnancy or breastfeeding.
11. Drug or alcohol abuse.
12. Severe psychiatric disorder which might interfere with the study treatment or
13. 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.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03383978
| Link to official Clinicaltrials.gov listing