RecruitingPhase 1Phase 2NCT05734560

D2C7-IT and 2141-V11 in Newly Diagnosed GBM Patients

Delivery of D2C7-IT and 2141-V11 Combination Immunotherapy in Residual Disease for Adult Patients With Newly Diagnosed MGMT Unmethylated Glioblastoma and Perilymphatic Subcutaneous Injections of 2141-V11


Sponsor

Darell Bigner

Enrollment

50 participants

Start Date

Sep 6, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this research study is to determine the safety and efficacy of administering a single intracerebral (within the brain) dose of investigational compounds called D2C7-immunotoxin (IT) and 2141-V11 in residual disease (within tumor margins) after surgery, followed by later repeated injections of 2141-V11 in the subcutaneous area (under the skin) around the lymph nodes of the head and neck for adults newly diagnosed with a type of cancerous brain tumor called glioblastoma. The word "investigational" means the study drugs are still being tested in research studies and are not approved by the U.S. Food and Drug Administration (FDA).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests two experimental immunotherapy drugs — D2C7-IT and 2141-V11 — delivered directly into the brain tumour through a catheter in patients newly diagnosed with glioblastoma (GBM), the most aggressive type of brain cancer. The drugs are given after completion of standard radiation therapy and chemotherapy. The goal is to test safety and whether these treatments can extend survival. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with glioblastoma (IDH wildtype, MGMT unmethylated, WHO grade 4) - You have completed standard radiation and chemotherapy (TMZ) - Your tumour has some remaining non-enhancing disease but the contrast-enhancing residual tumour is 3 cm or less - Your blood counts and organ function are adequate - You are in good enough health (Karnofsky score > 70%) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have a life-threatening brain herniation - You have an active serious infection, severe heart disease, or uncontrolled diabetes - You have HIV, hepatitis C, or known immunodeficiency - Your tumour involves the brainstem, cerebellum, or both sides of the brain - You are on more than 4 mg per day of dexamethasone (a steroid) within 2 weeks before treatment - You have had prior treatment for your GBM beyond standard surgery and radiation/chemo 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGD2C7-IT

D2C7-IT will be dosed at 166,075 ng in 36 mL.

DRUG2141-V11

2141-V11 will be dosed at 3 mg in 3.5 mL for CED administration. 2141-V11 in the cervical perilymphatic subcutaneous area will be dosed at 2 mg.


Locations(1)

Duke University Medical Center

Durham, North Carolina, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05734560