Purpose of this Study
We are doing this study to see if an experimental combination of drugs (D2C7-IT and 2141-V11) is a safe treatment for brain tumors.
Who Can Participate?
Eligibility
Adults 18 years of age and older who:
- Are diagnosed with Grade III or IV malignant glioma that has progressed or recurred
- Do not take a high dose of a steroid medicine called Decadron or dexamethasone
- Are not taking any types of medicines that affect your immune system
- Do not have any allergies to silicone, polyurethane, or titanium
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
*The study is currently open only to study subgroup #3. Subgroup #3 is the portion of the study when the study drug combination is given AND all participants in this portion will also have an investigational technology called the Tumor Monorail Device (TMD) implanted into their tumor.
If you choose to join this study, you will:
- Get the TMD implanted and have samples taken directly through the device
- Have the study drugs (D2C7-IT and 2141-V11) put into the area around your tumor
- Stay in the hospital for approximately 4 days
- Have physical exams
- Give blood samples
- Have MRI scans
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
A Phase 1 Trial of D2C7-IT in Combination with an Fc-engineered Anti-CD40 Monoclonal Antibody (2141-V11) Administered Intratumorally via Convection-Enhanced Delivery for Adult Patients with Recurrent Malignant Glioma
Principal Investigator
Annick
Desjardins
Protocol Number
PRO00104852
NCT ID
NCT04547777
Phase
I
Enrollment Status
Open to Enrollment