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New treatment option for Glioblastoma
Official title Intracranial Injection of NK-92/5.28.z Cells in Combination With Intravenous Ezabenlimab in Patients With Recurrent HER2-positive Glioblastoma
ClinicalTrials.gov ID: NCT03383978
What this study is testing
What is NK-92/5.28.z?
NK-92/5.28.z is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for glioblastoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Recurrent or refractory HER2-positive glioblastoma or its variant gliosarcoma in which relapse surgery (partial or total) or a biopsy (biopsy only...
- Biopsy is necessary (as determined by the treating physician) to rule out the differential diagnosis of pseudoprogression prior to relapse surgery.
- Patients must be candidates for relapse surgery, which must be postponable for four weeks.
- Prior therapy must include the standard of care for glioblastoma (radiotherapy and alkylating chemotherapy, or at least a part thereof if the therapy...
- Age ≥ 18 years
You likely can't join if
- Anti-angiogenic therapy e.g. with bevacizumab in the last four weeks prior to study entry
- Previous anti-PD-1 or anti-PD-L1 directed checkpoint inhibitor therapy (only "CAR2BRAIN-Check" cohort)
- Coagulation disorder (INR\>1.4 or PTT\>50sec) or anticoagulation in therapeutic dosage
- History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus...
- Patients with Type I diabetes mellitus not on a stable dose of insulin regimen
- Psoriatic arthritis (however, patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are...
See the full eligibility criteria
- Recurrent or refractory HER2-positive glioblastoma or its variant gliosarcoma in which relapse surgery (partial or total) or a biopsy (biopsy only for the "CAR2BRAIN-CheckR" cohort) is being planned. Those patients with...
- Biopsy is necessary (as determined by the treating physician) to rule out the differential diagnosis of pseudoprogression prior to relapse surgery.
- Patients must be candidates for relapse surgery, which must be postponable for four weeks.
- Prior therapy must include the standard of care for glioblastoma (radiotherapy and alkylating chemotherapy, or at least a part thereof if the 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 normal, 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...
- 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 time of inclusion, dexamethasone up to a total dose of 4...
- Informed consent explained to and signed by patient; patient given copy of informed consent.
- Karnofsky performance score of ≥ 70%
- Anti-angiogenic therapy e.g. with bevacizumab in the last four weeks prior to study entry
- Previous anti-PD-1 or anti-PD-L1 directed checkpoint inhibitor therapy (only "CAR2BRAIN-Check" cohort)
- Coagulation disorder (INR\>1.4 or PTT\>50sec) or anticoagulation in therapeutic dosage
- History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis...
- Patients with Type I diabetes mellitus not on a stable dose of insulin regimen
- Psoriatic arthritis (however, patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are permitted provided that they meet all of the following conditions:
- Rash must cover less than 10% of body surface area
- Disease is well controlled at baseline and only requiring low potency topical steroids
- No acute exacerbations of underlying condition within the previous 12 months (not requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, high potency or...
- Patients with clinical or laboratory signs for immunodeficiency or under immunosuppressive medication other than corticosteroids
- Severe intercurrent infection
- Known HIV, HBV (defined by detection of HBsAg) or HCV positivity (defined by detection of HCV-IgG)
- Chronic heart failure NYHA ≥III
- Patients with a prior solid organ transplantation or allogenic haematopoietic stem cell transplantation
- Patients 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Heidelberg, Baden-Wurttemberg, Germany
- Mannheim, Baden-Wurttemberg, Germany
- Mainz, Rhineland-Palatinate, Germany
- Frankfurt, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Heidelberg, Baden-Wurttemberg, Germany; Mannheim, Baden-Wurttemberg, Germany; Mainz, Rhineland-Palatinate, Germany; Frankfurt, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.