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
- 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
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?
If you choose to join this study, you will:
- 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
You will have regular follow-up visits after you leave the hospital. You will have a return clinic visit 2 weeks, 4 weeks, and 8 weeks after your hospital stay and then every 8 weeks for at least one year.
- 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
You will have regular follow-up visits after you leave the hospital. You will have a return clinic visit 2 weeks, 4 weeks, and 8 weeks after your hospital stay and then every 8 weeks for at least one year.
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 ACCRUAL