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D2C7-IT + 2141-V11 for Recurrent Glioblastoma

This study is testing the safety and effectiveness of a combination treatment, D2C7-IT and 2141-V11, for people with recurrent glioblastoma (rGBM). Glioblastoma is a type of brain cancer. The treatment involves infusing D2C7-IT and 2141-V11 directly into the brain where the tumor was removed, followed by injections of 2141-V11 in the neck. The study aims to see how safe this combination is over 5 years and how well it works over 6 years. You may be able to join if you are at least 18 years old, have a confirmed diagnosis of recurrent glioblastoma, and meet other health criteria. The study is planning to enroll about 46 participants. The current recruitment status is unclear.

Study design
This study plans to enroll about 46 participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
Participants will receive D2C7-IT and 2141-V11 infused into the brain, followed by repeated injections of 2141-V11 in the neck for at least a year, and potentially longer.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured for 5 years, and effectiveness will be measured for 6 years after the treatment.

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NCT06455605

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Darell Bigner
~46 participants
Updated 2025-10-23 on ClinicalTrials.gov
What's tested:D2C7-IT2141 V11

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Outcome - Safety
Measured over 5 years
+1 more outcome measured

Conditions

Recurrent Glioblastoma IDH Wildtype

Explore related trials

GlioblastomaIDH1 wt Allele

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Annick Desjardins, MD · PRINCIPAL_INVESTIGATOR · Duke University

Who to contact

Annick Desjardins, MD
[email protected]
919-684-5301
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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

1 week prior to starting the study drug 7. Patients may not be less than 12 weeks from radiation therapy, unless progressive disease outside of the radiation field or 2 progressive scans at least 4 weeks apart or histopathologic confirmation 8. Patients who have not completed all standard of care treatments, including surgical procedure and radiation therapy (Please note: For patients under 65 years old, standard radiation therapy is typically at least 59 Gy in 30 fractions over 6 weeks. For patients 65 years or older, standard RT is often reduced to a minimum 40 Gy in 15 fractions over 3 weeks.)

What this trial measures

  • Primary Outcome - Safety5 years

    Describe the safety of the combination of D2C7-IT+2141-V11 administered in non-enhancing tumor of recurrent GBM patients via CED, followed by cervical perilymphatic subcutaneous injections of 2141-V11. The proportion of patients who experience unacceptable toxicity will be reported.

  • Primary Outcome - Efficacy6 years

    To assess overall survival defined as the time between initiation of treatment with D2C7-IT+2141-V11 and death or last follow-up if alive. Median overall survival will be reported