Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT06455605
Brief 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.
Study:
NCT06455605
Study Brief:
Protocol Section:
NCT06455605