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
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

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.

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
ClinicalTrials.gov