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

ConditionRecurrent Glioblastoma IDH Wildtype

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorDarell Bigner

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old at the time of entry into the study

Histopathologically confirmed WHO grade 4 IDHwt GBM (high grade glioma with molecular features of glioblastoma will be eligible)

Karnofsky Performance Score (KPS) ≥ 70%

Hemoglobin ≥ 9 g/dl prior to biopsy

Disqualifiers

Females who are pregnant (negative pregnancy test at screening visit) or breast- feeding

Patients with an impending, life-threatening cerebral herniation syndrome, based on the assessment of the study neurosurgeons or their designate

Patients with an active infection requiring intravenous treatment or having an unexplained febrile illness (Tmax > 99.5°F/37.5°C)

Patients with known immunosuppressive disease or known human immunodeficiency virus infection

Trial design

Design model

Single group

Treatments tested in this trial

D2C7-IT
Drug
D2C7-IT will be dosed at 166,075 ng in 36 mL.
2141 V11
Drug
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.

Treatment groups

46 Participants

are divided into 1 treatment group

Group A: D2C7-IT + 2141-V11Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

Primary Outcome - Safety

Describe the safety of the combination of D2C7-IT+2141-V11 administered in non-enhancing tumor of recurrent GBM patients via CED, followed by cervical perilymphatic subcutaneous injections of 2141-V11. The proportion of patients who experience unacceptable toxicity will be reported.

Time frame

5 years

Primary Outcome - Efficacy

To assess overall survival defined as the time between initiation of treatment with D2C7-IT+2141-V11 and death or last follow-up if alive. Median overall survival will be reported

Time frame

6 years

Sponsors and contacts

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Darell Bigner

Lead sponsor

Duke University

Sponsor institution

Rockefeller University

Collaborator

Source ClinicalTrials.gov

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