D2C7-IT + 2141-V11 for Brain Cancer

Overseen by Annick Desjardins, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Darell Bigner

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Annick Desjardins, MD

Principal Investigator

Duke University

Eligibility Criteria

This trial is for adults over 18 with a specific brain cancer called WHO grade 4 IDHwt GBM. They must have had surgery recently, be able to undergo MRI scans, and not be pregnant or breastfeeding. Participants need normal blood counts and organ function tests, agree to use birth control, and can't have certain medical conditions or recent treatments with other cancer therapies.

Inclusion Criteria

My brain tumor is a confirmed grade 4 and not IDH mutant.

I am 18 years old or older.

Hemoglobin ≥ 9 g/dl prior to biopsy

Exclusion Criteria

Patients with albumin allergy

I am not pregnant or breastfeeding.

I am at risk of a severe brain condition due to pressure increase.

Treatment Details

Interventions

• 2141-V11 (Virus Therapy)
• D2C7-IT (Virus Therapy)

Trial Overview The study tests D2C7-IT combined with 2141-V11 in patients who've had brain surgery for recurrent glioblastoma. The treatment involves direct infusion into the brain followed by injections near lymph nodes over several weeks to see if it's safe and effective against the tumor.

Participant Groups

Group I: D2C7-IT + 2141-V11 Experimental Treatment 2 Interventions

Single D2C7-IT intratumoral infusion (4613.2 ng/mL in 36 mL) over 72 hours followed by an 2141-V11 infusion over 7 hours. This is followed by injections of 2141-V11 (2mg) in the cervical perilymphatic (CPLI) subcutaneous area ipsilateral to the tumor at weeks 2, 4, 7, 10 and then every 3 weeks until week 49. After week 49 (equivalent of 1 year of every 3 weeks CPLI of 2141-V11), patients who have completed 1 year of CPL subcutaneous injections of 2141-V11 at 2 mg every 3 weeks, who benefit from the therapy, and desire to continue on therapy, will receive CPLI of 2141-V11 at 2 mg every 4-6 weeks.

Who Is Running the Clinical Trial?

Darell Bigner

Lead Sponsor

Trials

8

Recruited

380+

Rockefeller University

Collaborator

Trials

162

Recruited

16,700+