D2C7 + Anti-CD40 for Malignant Glioma

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
For more information about this study, please contact the team at 919-684-5301.

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
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 Enrollment