OncoMatch/Clinical Trials/NCT06455605
D2C7-IT + 2141-V11 Combination Post-resection in rGBM
Is NCT06455605 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including D2C7-IT and 2141 V11 for recurrent glioblastoma idh wildtype.
Treatment: D2C7-IT · 2141 V11 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 wild-type
IDHwt GBM
Allowed: MGMT promoter methylation
If the MGMT promoter in their tumor is known to be unmethylated, patients are not mandated to have received chemotherapy prior to participating in this trial. If the MGMT promoter in their tumor is known to be methylated or the MGMT promoter methylation status is unknown at time of screening, patients must have received at least one chemotherapy regimen prior to participating in this trial
Disease stage
Required: Stage WHO GRADE 4 (WHO)
Grade: 4 (WHO)
WHO grade 4 IDHwt GBM
Prior therapy
Must have received: surgical procedure — standard of care
Patient must have undergone resection per the recommendation of their treating physician 3-5 weeks prior to administration of D2C7-IT
Must have received: radiation therapy — standard of care
Patients who have not completed all standard of care treatments, including surgical procedure and radiation therapy
Cannot have received: chemotherapy
Exception: nitrosourea (6 weeks), metronomic dosed chemotherapy such as daily etoposide or cyclophosphamide (1 week)
Patients may not have received chemotherapy or bevacizumab ≤ 4 weeks [except for nitrosourea (6 weeks), or metronomic dosed chemotherapy such as daily etoposide or cyclophosphamide (1 week)] prior to starting the study drug unless patients have recovered from side effects of such therapy
Cannot have received: bevacizumab (bevacizumab)
Patients may not have received chemotherapy or bevacizumab ≤ 4 weeks ... prior to starting the study drug unless patients have recovered from side effects of such therapy
Cannot have received: immunotherapy
Patients may not have received immunotherapy ≤ 4 weeks prior to starting the study drug unless patients have recovered from side effects of such therapy
Cannot have received: tumor treating fields (Optune)
Patients may not have received treatment with tumor treating fields (e.g., Optune®) 1 week prior to starting the study drug
Cannot have received: radiation therapy
Exception: unless progressive disease outside of the radiation field or 2 progressive scans at least 4 weeks apart or histopathologic confirmation
Patients may not be less than 12 weeks from radiation therapy, unless progressive disease outside of the radiation field or 2 progressive scans at least 4 weeks apart or histopathologic confirmation
Lab requirements
Blood counts
Hemoglobin ≥ 9 g/dl prior to biopsy; Platelet count ≥ 100,000/µl unsupported is necessary for eligibility; Platelet count ≥ 125,000/µl required for biopsy/catheter insertion (can be attained with transfusion); Neutrophil count ≥ 1000 prior to biopsy
Kidney function
Creatinine ≤ 1.5 x normal range prior to biopsy
Liver function
Total bilirubin ≤ 1.5 x ULN prior to biopsy (Exception: Gilbert's Syndrome ≤ 3.0 x ULN); AST/ALT ≤ 2.5 x ULN
Hemoglobin ≥ 9 g/dl prior to biopsy; Platelet count ≥ 100,000/µl unsupported is necessary for eligibility ... Platelet count ≥ 125,000/µl is required for the patient to undergo biopsy and catheter insertion ... Neutrophil count ≥ 1000 prior to biopsy; Creatinine ≤ 1.5 x normal range prior to biopsy; Total bilirubin ≤ 1.5 x ULN prior to biopsy (Exception: ... Gilbert's Syndrome ... ≤ 3.0 x ULN); AST/ALT ≤ 2.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Duke University Medical Center · Durham, North Carolina
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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