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

Recruiting Phase 1 Interventional Study
Recurrent Glioblastoma IDH Wildtype
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
46 (estimated)
Sponsor
Darell Bigner · Other
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About 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 the…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years old at the time of entry into the study 2. Histopathologically confirmed WHO grade 4 IDHwt GBM (high grade glioma with molecular features of glioblastoma will be eligible) 3. Karnofsky Performance Score (KPS) ≥ 70% 4. Hemoglobin ≥ 9 g/dl prior to biopsy 5. Plat…
Contacts

Annick Desjardins, MD

919-684-5301

dukebrain1@dm.duke.edu

CONTACT

Stevie Threatt

919-684-5301

dukebrain1@dm.duke.edu

CONTACT