D2C7 + Anti-CD40 for Malignant Glioma
What is the Purpose of this Study?
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.
What is the Condition Being Studied?
Brain Tumors
Who Can Participate in this Study?
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
Age Group
Adults
Participating Institutions
What is Involved?
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.
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
Protocol Number
IRB:
PRO00104852
NCT:
NCT04547777
ClinicalTrials.gov
View on ClinicalTrials.gov