Last updated on August 2017

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 43 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. Eligible subjects will receive intratumoral infusion of MDNA55 administered via convection-enhanced delivery (CED).

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 target, IL4R, is an ideal but under-exploited target for the development of cancer therapeutics, as it is frequently and intensely expressed on a wide variety of human carcinomas. Expression levels of IL4R are low on the surface of healthy and normal cells, but increase several-fold on cancer cells. A majority of cancer biopsy and autopsy samples from adult and pediatric brain tumors, including recurrent glioblastoma biopsies, have been shown to over-express the IL4R. Cells that do not express the IL4R biomarker do not bind to MDNA55 and are, therefore, not subject to PE-mediated effects. This is a single-arm, open-label, multicenter study in approximately 43 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. 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 will be performed 14 days after CED infusion. Thereafter, efficacy and safety assessments will be performed at 30, 60, 120, 180, 270, and 360 days after CED infusion. Subjects who discontinue before the Day 360 visit will undergo all the procedures scheduled for the Day 360 visit at the time of discontinuation.

Clinical Study Identifier: NCT02858895

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Nicholas Butowski, MD

University of California San Francisco
San Francisco, CA United States
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Achal Achrol, MD

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

Boca Raton Regional Hospital
Boca Raton, FL United States
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Mark Souweidane, MD

Weill Cornell Medical Center - New York Presbyterian
New York, NY United States
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Dina Randazzo, MD

Duke University Medical Center
Durham, NC United States
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Michael Vogelbaum, MD, PhD

Cleveland Clinic
Cleveland, OH United States
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Russell Lonser, MD

Ohio State University
Columbus, OH United States
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Toral Patel, MD

University of Texas Southwestern Cancer Center
Dallas, TX United States
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Andrew Brenner, MD

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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