D2C7 + Anti-CD40 for Malignant Glioma - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Tumores cerebrales

Who Can Participate in the 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
  • Do not have any allergies to silicone, polyurethane, or titanium

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

Grupo etario
Adultos

What is Involved?

*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.

Si elige unirse a este estudio, podrá:

  • 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
  • Someterse a exámenes físicos
  • Dar muestras de sangre
  • 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.

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
Especialista en neuro-oncología
Protocol Number
IRB: PRO00104852
NCT: NCT04547777
Phase
Fase I
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción
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