RecruitingPhase 1NCT06455605

D2C7-IT + 2141-V11 Combination Post-resection in rGBM

Clinical Trial of D2C7-IT + 2141-V11 Combination Immunotherapy Administered Via Convection Enhanced Delivery in Non-enhancing Tumor Post-resection of Recurrent Glioblastoma, Followed by Cervical Perilymphatic Subcutaneous Injections of 2141-V11

Sponsor

Darell Bigner

Enrollment

46 participants

Start Date

Mar 17, 2025

Study Type

INTERVENTIONAL

Conditions

Recurrent Glioblastoma, IDH-Wildtype

Summary

The purpose of this study is to assess the safety and efficacy of the combination of D2C7-IT+2141-V11 administered in the non-enhancing tumor of patients with resected recurrent glioblastoma (rGBM) via convection enhanced delivery (CED), followed by subcutaneous cervical perilymphatic injections (CPLIs) of 2141-V11 2 and 4 weeks post infusion, then every 3 weeks for a year, and every 4-6 weeks thereafter if patients benefit from therapy.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two experimental treatments — D2C7-IT and 2141-V11 — delivered directly into the brain after surgery in patients with recurrent glioblastoma, the most aggressive type of brain tumor. These treatments are designed to target and kill cancer cells. **You may be eligible if...** - You are 18 or older - You have been diagnosed with recurrent glioblastoma (a grade 4 brain tumor) confirmed by pathology - You are in reasonably good functional health (Karnofsky score ≥ 70%) - Your blood counts (hemoglobin and platelets) meet the required thresholds **You may NOT be eligible if...** - Your hemoglobin or platelet counts are too low - Your overall health or functioning does not meet the study threshold - You have other conditions that make brain surgery or the study treatment unsafe 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 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

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NCT06455605

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