Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455605
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-07
Brief Title:
D2C7-IT 2141-V11 Combination Post-resection in rGBM
Sponsor:
Darell Bigner
Organization:
Duke University
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the safety and efficacy of the combination of D2C7-IT2141-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 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None