Convection-Enhanced Delivery (CED) of MDNA55 in Adults With Recurrent or Progressive Glioblastoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02858895|
Recruitment Status : Active, not recruiting
First Posted : August 8, 2016
Last Update Posted : May 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Grade IV Astrocytoma Glioblastoma Multiforme Grade IV Glioma||Drug: MDNA55||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Non-Randomized, Multi-Center Phase-2 Study of Convection-Enhanced Delivery (CED) of MDNA55 in Adults With Recurrent or Progressive Glioblastoma|
|Actual Study Start Date :||April 11, 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||March 2020|
Single infusion of MDNA55 via convection enhanced delivery (CED).*
*Subjects may be eligible to receive a second administration of MDNA55.
MDNA55 is an engineered circularly permuted interleukin-4 (cpIL-4) genetically fused to the catalytic domain of the pseudomonas exotoxin A (PE).
- Overall Survival (OS) [ Time Frame: 12 months ]OS, time from treatment until death
- Objective Response Rate (ORR) [ Time Frame: 12 months ]ORR, determined by independent central review (per RANO-based criteria)
- Progression Free Survival (PFS) [ Time Frame: 12 months ]PFS, time from treatment until disease progression (per RANO-based criteria) or death
- Serious adverse events (SAEs) [ Time Frame: 12 months ]Incidence of SAEs
- Treatment emergent adverse events (AEs) [ Time Frame: 12 months ]Incidence of Treatment-Emergent AEs
- Pharmacokinetics (PK) of MDNA55 [ Time Frame: 14 days ]Blood samples will be collected to determine levels of MDNA55
- Anti-MDNA55 antibody [ Time Frame: 12 months ]Blood samples will be collected to determine anti-drug antibody titers
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): NCT02858895
|United States, California|
|University of California San Francisco|
|San Francisco, California, United States, 94143|
|John Wayne Cancer Institute at Providence Saint John's Health Center|
|Santa Monica, California, United States, 90404|
|United States, Florida|
|Boca Raton Regional Hospital|
|Boca Raton, Florida, United States, 33486|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Texas|
|Cancer Therapy and Research Center at The University of Texas Health Science Center at San Antonio|
|San Antonio, Texas, United States, 78229|