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

NCT06455605 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-10-23

No results posted yet for this study

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.

Conditions

  • Recurrent Glioblastoma IDH Wildtype

Interventions

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.

Sponsors & Collaborators

  • Rockefeller University

    collaborator OTHER

  • Darell Bigner

    lead OTHER

Principal Investigators

  • Annick Desjardins, MD · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-17
Primary Completion
2029-01-31
Completion
2030-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06455605 on ClinicalTrials.gov