RecruitingPhase 1NCT04547777

Phase 1 Trial of D2C7-IT in Combination With 2141-V11 for Recurrent Malignant Glioma

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 Followed by Perilymphatic Injections of 2141-V11 and Assessment of the Tumor Monorail for Adult Patients With Recurrent Malignant Glioma


Sponsor

Darell Bigner

Enrollment

90 participants

Start Date

Jul 9, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase 1 study of an anti-CD40 monoclonal antibody (2141-V11) in combination with D2C7-IT for patients with recurrent World Health Organization (WHO) grade III or IV malignant glioma at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing two experimental treatments injected directly into the brain tumor — D2C7-IT (a targeted toxin) and 2141-V11 (an immune-activating antibody) — for patients with high-grade brain tumors (malignant glioma) that have come back after initial treatment. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of a recurrent high-grade (grade 3 or 4) brain tumor (malignant glioma or glioblastoma) in the upper part of the brain - Your tumor has been confirmed to have returned after prior treatment - You or your partner meets reproductive safety requirements - Your general health and brain function are adequate for the procedure **You may NOT be eligible if...** - You have a brain tumor in the brainstem or other inaccessible location - You have a very low performance status or significant neurological disability - You are pregnant or breastfeeding - You have serious active infections or uncontrolled medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGD2C7-IT

D2C7-IT intratumoral infusion

DRUG2141-V11

2141-11 intratumoral infusion


Locations(1)

Duke University Medical Center

Durham, North Carolina, United States

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NCT04547777


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