Last updated on October 2018

Convection-Enhanced Delivery (CED) of MDNA55 in Adults With Recurrent or Progressive Glioblastoma

Brief description of study

This is a single-arm, open-label, multicenter study in approximately 52 adults with primary (de novo) GB that has recurred or progressed (first or second recurrence, including this recurrence) after treatment(s) including surgery and radiotherapy with or without chemotherapy and following discontinuation of any previous standard or investigational lines of therapy.

Detailed Study Description

The study drug, MDNA55, is a fusion protein comprising a genetically engineered Interleukin-4 (IL-4) linked to a modified version of the Pseudomonas aeruginosa exotoxin A (PE). MDNA55 binds to the IL-4 receptor (IL4R), over-expressed by cancer cells and non-malignant immunosuppressive cells of the tumor microenvironment (TME), and delivers a potent cell-killing agent, PE.

The study will be conducted at up to 10 clinical sites following institutional review board approval and completed informed consent.

Subjects that meet the study eligibility criteria will undergo surgery associated with study drug administration. MDNA55 will be administered locally by convection-enhanced delivery (CED).

Post-treatment follow-up assessment of safety and efficacy will be performed monthly for the first 6 months and bimonthly thereafter for approximately 1 year after study drug administrations. Subjects will continued to be followed for survival and post-study treatment(s) of GB after study completion or withdrawal.

Clinical Study Identifier: NCT02858895

Contact Investigators or Research Sites near you

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Nurse Line

University of California San Francisco
San Francisco, CA United States
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Naj Boucher

John Wayne Cancer Institute at Providence Saint John's Health Center
Santa Monica, CA United States
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Pilar Zuniga, MD

Boca Raton Regional Hospital
Boca Raton, FL United States
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Brain Tumor Center

Duke University Medical Center
Durham, NC United States
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Cathy Brewer, RN

Cleveland Clinic
Cleveland, OH United States
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Epp Goodwin

Cancer Therapy and Research Center at The University of Texas Health Science Center at San Antonio
San Antonio, TX United States
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Michael McGehee, MS

Oregon Health & Science University
Portland, OR United States
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Timothy Prior

Hospital of the University of Pennsylvania
Philadelphia, PA United States
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Karolina Karas

Mazovian Brodnowski Hospital
Warsaw, Poland
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