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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

INCLUSION CRITERIA:

1. Subjects must be ≥ 18 years old and have a life expectancy ≥ 12 weeks. 2. Histologically proven, primary (de novo) GB that has recurred or progressed (first or second recurrence, including this recurrence) 3. Confirmation that archived tissue is available from first diagnosis of GB for biomarker analysis. 4. Recurrent tumor must be supratentorial, contrast-enhancing GB no smaller than 1 cm x 1 cm (largest perpendicular dimensions) and no larger than 4 cm maximum in a single direction based on MRI taken within 14 days prior to catheter placement. 5. Karnofsky Performance Score (KPS) ≥ 70. 6. Subjects must be able and willing to undergo multiple brain MRI examinations. 7. Subjects must be able and willing to comply with all study procedures. 8. Any related toxicities following discontinuation of prior GB therapies must have resolved to CTCAE Grade 1 or lower prior to inclusion in this study.

EXCLUSION CRITERIA:

1. Prior treatment with cytotoxic chemotherapy. 1. Temozolomide (standard induction and / or maintenance dosing) within the past 4 weeks prior to planned infusion. 2. "Metronomic" Temozolomide (low-dose, continuous administration) within the past 7 days prior to planned infusion. 3. Nitrosoureas within the past 6 weeks prior to planned infusion. 4. Treatment with any other cytotoxic agent within the past 4 weeks prior to planned infusion. 2. Prior investigational treatment within the past 4 weeks or prior immunotherapy or antibody therapy within the past 4 weeks prior to planned infusion. 3. Prior treatment with bevacizumab (Avastin) or other vascular-endothelial growth factor (VEGF) inhibitors or VEGF-receptor signaling inhibitors within the past 4 weeks prior to planned infusion. 4. Prior therapy that included interstitial brachytherapy or Gliadel® Wafers (carmustine implants) within the past 12 weeks prior to planned infusion. 5. Prior surgery (including stereotactic radiosurgery and biopsy procedures) within the past 4 weeks prior to planned infusion. 6. Ongoing Optune© therapy within 5 days of planned infusion. 7. Secondary GB (i.e., GB that progressed from low-grade diffuse astrocytoma or AA) 8. Known mutation in either the isocitrate dehydrogenase 1 (IDH1) or the IDH2 gene. 9. Tumor in the brainstem (not including fluid-attenuated inversion recovery [FLAIR] changes), an infratentorial tumor, diagnosis of gliomatosis cerebri (highly infiltrative T2 hyperintense tumor with ill-defined margins encompassing at least three lobes of the brain. 10. Tumor with a mass effect (e.g. 1-2 cm midline shift) 11. Subjects with tumors for which the preponderance of tissue is not of the type in which convection would be possible (e.g. preponderance of cystic component) 12. Tumor with geometric features that make them difficult to adequately cover the tumor volume with infusate by using CED catheters. 13. Clinical symptoms that are thought by the Investigator to be caused by uncontrolled increased intracranial pressure, hemorrhage, or edema of the brain. 14. Any condition that precludes the administration of anesthesia. 15. Known to be human immunodeficiency virus positive. 16. Concurrent or a history of any significant medical illnesses that in the Investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the subject's ability to tolerate the study drug therapy and/or put the subject at additional risk or interfere with the interpretation of the results of this trial. 17. Known history of allergy to gadolinium contrast agents. 18. Presence of another type of malignancy requiring treatment within < 3 years prior to the screening visit, except for adequately treated carcinoma in-situ of the cervix, prostate cancer not actively treated, and basal or squamous cell carcinoma of the skin

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02858895
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Medicenna Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma, Grade IV Astrocytoma, Glioblastoma Multiforme, Grade IV Glioma
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

Experimental: MDNA55

Single infusion of MDNA55 via convection enhanced delivery (CED).* *Subjects may be eligible to receive a second administration of MDNA55.

Interventions

Drug: - MDNA55

MDNA55 is an engineered circularly permuted interleukin-4 (cpIL-4) genetically fused to the catalytic domain of the pseudomonas exotoxin A (PE).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California San Francisco, San Francisco, California

Status

Address

University of California San Francisco

San Francisco, California, 94143

Santa Monica, California

Status

Address

John Wayne Cancer Institute at Providence Saint John's Health Center

Santa Monica, California, 90404

Boca Raton Regional Hospital, Boca Raton, Florida

Status

Address

Boca Raton Regional Hospital

Boca Raton, Florida, 33486

Duke University Medical Center, Durham, North Carolina

Status

Address

Duke University Medical Center

Durham, North Carolina, 27710

Oregon Health & Science University, Portland, Oregon

Status

Address

Oregon Health & Science University

Portland, Oregon, 97239

Philadelphia, Pennsylvania

Status

Address

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19107

San Antonio, Texas

Status

Address

Cancer Therapy and Research Center at The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229