NCT06455605

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Darell Bigner · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Approximately 46 evaluable patients will be enrolled in this study. Enrolled patients must have previously undergone maximal safe surgical tumor resection, with histopathologic confirmation of recurrence of GBM. Post-operative MRI also must have demonstrated a residual area of non-enhancing disease (as assessed by T2/ FLAIR images) that is amenable to infusion (no larger than 3 x 3 cm of residual enhancing disease). Study participants will receive D2C7-IT and 2141-V11 infused in the residual disease via CED followed by repeated, imaging guided injections of 2141-V11 in the cervical perilymphatic subcutaneous area ipsilateral to the tumor.

Conditions

• Recurrent Glioblastoma IDH Wildtype

Interventions

Type	Name	Description
DRUG	D2C7-IT	D2C7-IT will be dosed at 166,075 ng in 36 mL.
DRUG	2141 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.

Timeline

• Start date: 2025-03-17
• Primary completion: 2029-01-31
• Completion: 2030-01-31
• First posted: 2024-06-12
• Last updated: 2025-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study